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Transcript
BMJ Open is committed to open peer review. As part of this commitment we make the peer review
history of every article we publish publicly available.
When an article is published we post the peer reviewers’ comments and the authors’ responses
online. We also post the versions of the paper that were used during peer review. These are the
versions that the peer review comments apply to.
The versions of the paper that follow are the versions that were submitted during the peer review
process. They are not the versions of record or the final published versions. They should not be cited
or distributed as the published version of this manuscript.
BMJ Open is an open access journal and the full, final, typeset and author-corrected version of
record of the manuscript is available on our site with no access controls, subscription charges or pay-
per-view fees (http://bmjopen.bmj.com).
If you have any questions on BMJ Open’s open peer review process please email
Participatory Research in Ottawa: Management and Point-of-Care for Tobacco Dependence (PROMPT) Project
Inner City Community Based Participatory Action Research
– a potential novel way to tackle the growing opioid use crises? Prospective Cohort Project
Journal: BMJ Open
Manuscript ID bmjopen-2017-018416
Article Type: Research
Date Submitted by the Author: 28-Jun-2017
Complete List of Authors: Pakhale, Smita; Ottawa Hospital; Ottawa Hospital Research Institute
Kaur, Tina; Ottawa Hospital Research Institute Charron, Catherine; Department of Medicine in Ottawa; Ottawa Hospital Florence, Kelly; The Bridge Engagement Centre Rose, Tiffany; The Bridge Engagement Centre Jama, Sadia; Ottawa Hospital Research Institute Boyd, Rob; Sandy Hill Community Health Centre Haddad, Joanne; Canadian Mental Health Association Ottawa Branch Alvarez, Gonzalo ; Ottawa Hospital; Ottawa Hospital Research Institute Tyndall, Mark; British Columbia Centre for Disease Control; University of British Columbia
<b>Primary Subject
Heading</b>: Addiction
Secondary Subject Heading: Public health, Smoking and tobacco, Health policy
Keywords: Health policy < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, Public health < INFECTIOUS DISEASES, EPIDEMIOLOGY, SOCIAL MEDICINE
For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml
Participatory Research in Ottawa: Management and Point-of-Care
for Tobacco Dependence (PROMPT) Project
Inner City Community Based Participatory Action Research – a potential novel way to
tackle the growing opioid use crises? Prospective Cohort Project
Dr. Smita Pakhale, MD, MSc1,2,3*, Tina Kaur, MPH2, Dr. Catherine Charron, MD1,3, Kelly Florence4, Tiffany Rose4, Sadia Jama, MSc2, Robert Boyd, BA5, Joanne Haddad, RN6, Dr. Gonzalo Alvarez, MD, MSc1,2,3, Dr. Mark Tyndall, MD, PhD7,8 1The Ottawa Hospital, Ottawa, Canada 2The Ottawa Hospital Research Institute (OHRI), Ottawa, Canada 3University of Ottawa, Ottawa, Canada 4Community (peer) Researcher, the Bridge Engagement Centre, Ottawa, Canada 5Oasis, Sandy Hill Community Health Centre, Ottawa, Canada 6Canadian Mental Health Association, the Ottawa Branch, Canada 7British Columbia Centre for Disease Control, Vancouver, Canada 8University of British Columbia, Vancouver, Canada *Corresponding Author: Dr. Smita Pakhalé, MD, FRCPC, MSc (Epi & Biostat) Associate Scientist - Ottawa Hospital Research Institute Assistant Professor - University of Ottawa Staff Respirologist - Division of Respiratory Medicine The Ottawa Hospital 501 Smyth Road Ottawa, Ontario, K1H 8L6 Canada Phone: 613-737-8899 Ex. 79428 email: [email protected] http://www.ohri.ca/Profiles/pakhale.asp SP, KF, MT contributed to the conception and design of the study. SP, TK, KF, TR, CC, RB, and JH, made substantial contributions to the acquisition of the data, data entry, or data analysis and data interpretation. SP, TK, CC, KF, TR, SJ, RB, JH, and MT were all involved in the drafting of the manuscript or the revisions made to the manuscript. All authors have given final approval of the version of the manuscript submitted for publication, and agree to be accountable for all aspects of the work. Key Words: Tobacco dependence, patient engagement, opioid crises, community-based participatory action research, peer-led, drug use, substance use disorder Word Count: 5441
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Objective: To determine the feasibility of a Community-Based Participatory tobacco-dependence strategy (PROMPT) in Ottawa’s inner city population. Design: Community-Based Participatory Prospective cohort Intervention: We recruited 80 people who use drugs, followed them for six months while providing access to counselling, nicotine replacement therapy and peer-support in a community setting. Setting: Community research office located in downtown Ottawa, at the centre of low-income housing, Ottawa shelter services, and street based drug consumption.
Primary Outcome: retention rate at 6-month follow up; Secondary Outcome: biochemically-validated 7-day point prevalence smoking abstinence at 26 weeks, defined as self-reported abstinence in the past 7 days with exhaled carbon monoxide ≤ 10 ppm. Results: The average age of participants’ was 43.8 years with a mean of 27.3 years of smoking. Participants were 70% male, 33.7% reported less than a high-school education, 21% identified as indigenous, and 43.8% reported an income between $1000-1999/month. Baseline mean daily cigarette use was 20.5 cigarettes and 9.3 cigarettes at study end with mean reduction of 11.2 cigarettes at six months (p=0.0001). The 6 month follow-up rate was 42.5%. Considerable reduction in other substance use was reported (18.8%, p=0.0011), including a reduction in the opioids heroin (6.3%, p=0.0241), fentanyl (2.6%), and OxyContin (3.8%). Study findings also reveal psycho-socio-economic benefits such as improved health, return to work, and greater community engagement. Conclusions: The PROMPT project describes socio-economic variables associated with tobacco and poly-substance use. A program focused on tobacco dependence, easily accessible in the community, and led by community peers with lived experience is feasible to implement and successful in supporting positive life changes. PROMPT’s patient engagement model is an effective harm-reduction strategy for the growing opioid use crisis and can improve the health outcomes of marginalized at-risk populations worldwide.
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Tobacco smoking is a leading preventable cause of morbidity and mortality in Canada and globally.(1) The effects of nicotine, the pharmacologically active agent in tobacco products, is acutely toxic as nicotine readily enters the body through the lungs and is distributed rapidly throughout the blood-stream.(1) Beyond the addictive properties of nicotine, it activates multiple biologic pathways that play a role in hampering fetal growth and development, the immune system, the cardiovascular system, and the central nervous system; in addition to stimulating carcinogenesis.(1) The life expectancy of tobacco smokers is cut short as smoking is documented to shorten life far more than most other risk factors for premature death; smokers are estimated to lose more than a decade of life in comparison to non-smokers.(1) Despite a steady decline in cigarette smoking since 1964, large disparities in rates of tobacco use remain evident across groups defined by race, ethnicity, educational level, and socioeconomic status (SES) and across regions in all high-income countries including Canada.(1-3) Major health disparities exist between smokers and non-smokers and are evident with lower socio-economic status groups having disproportionately increased rates of tobacco use.(4) Globally, disadvantaged groups between the ages of 35 and 69 are much more likely to die from tobacco smoking.(3,5) Tobacco is responsible for about half of the socioeconomic difference in death rates for this age range.(3,6) Specifically, smoking tobacco rates are higher among the long-term unemployed, homeless or insecurely housed, mentally ill, prisoners, single parents, people with limited education, people with low income, and some groups of immigrants and ethnic minorities(7,8) which are more likely to be socioeconomically disadvantaged.(8-12) Poly-substance use and tobacco use are common co-occurrences in homeless or insecurely housed most at-risk populations in North America.(13) Although the city of Ottawa (Canada) has one of the lowest smoking rates in the Province of Ontario at 9-12 %,(14,15) major disparities exist as disproportionately higher rates of tobacco smoking were observed among people who use drugs (PWUD). According to the PROUD (Participatory Research in Ottawa: Understanding Drugs) study of Ottawa inner city residents who use multiple drugs, 96 % of respondents reported they had smoked cigarettes in the past year.(15,16) Furthermore, similar trends are observed in the United States, for example 29% of the general population smoked in comparison to 75-100% for people who abuse alcohol, PWUD, and those receiving methadone maintenance. Many people recovering from poly-substance addictions die from smoking related illnesses.(17,18) Reducing smoking, particularly among lower SES groups provides opportunities to improve the health and well-being of the community at large while also reducing the burden of health care.(11,19) Despite well-established benefits of smoking cessation,(1,20) common misconceptions exist when treating PWUD for example that smoking cessation will interfere with drug dependence treatment by becoming an additional stressor. Health care providers may bring in their own biases and feel that smoking tobacco is not a priority issue in comparison to other substance use.(17) This very issue surfaced at a community knowledge forum for this study (PROMPT) on May 2015, where a public health nurse states: “I am always conflicted as to when is the best time to discuss tobacco issues with my clients when they have so many other things going on”; to which a PROMPT participant replies: “Anytime is a good time! We all are fed up with smoking tobacco because of the day-to-day challenges, but it is very hard to quit. Any help
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is always welcome!” (16) It is well documented that 44-80 % of PWUD are interested in quitting tobacco,(20,21) 72 % of PWUD reported trying to quit tobacco smoking previously, and 69 % expressed interest in participating in a group smoking cessation program. Moreover, 82 % of PWUD indicated interest in receiving a prescription for nicotine replacement medication, and among those who considered cessation, approximately 56 % reported being interested in both group intervention and nicotine replacement.(20,21) Therefore, the motivation and active effort toward quitting smoking tobacco exists within the PWUD community - however there is a lack of comprehensive programs designed to cater to the most at-risk individuals in Ottawa. Few research studies have followed poly-substance users and tracked their smoking activity as well as smoking cessation efforts. Importantly, with the growing crises of opioid use in the US and Canada, we urgently need novel strategies to deal with the synchronicity of co-addictions.(22-24) A synchronicity that is captured well in the following quote by a PROMPT project community
(peer) researcher at a community knowledge forum: “It’s like milk and cookies, you drink and you smoke, you do drugs and you smoke”. Consequently, a community-based participatory action research project was conducted in the inner city population of Ottawa with PWUD.(15) The purpose of the project was to assess the feasibility of implementing a community-based participatory tobacco dependence strategy in Ottawa’s inner city, in addition to obtaining a better understanding of tobacco smoking patterns and tobacco and poly-substance use reduction and cessation efforts. The PROMPT project aimed to demonstrate that a program focused on tobacco-dependence available in the community and with meaningful ‘patient engagement’ of community members, representative of the target population, is feasible and able to improve quality of life and reduce tobacco use.
Methods
The Participatory Research in Ottawa: Management and Point-of-Care for Tobacco Dependence (PROMPT) project was a prospective cohort study with PWUD using a community-based participatory action model. The inclusion criteria were: 1) currently living in Ottawa for at least past 3 months prior to enrolment, 2) 16 years or older, 3) have used drugs in the past year (excluding marijuana and alcohol), and 4) had smoked tobacco in the past 7 days. The project was approved by the Ottawa Health Science Network Research Ethics Board and written informed consent was obtained from all participants. Four individuals with lived experience, members of the PROMPT target population (ex/current tobacco smoker, homeless or at-risk for homelessness, poly-substance user), were selected as community (peer) researchers. The community researchers were selected through a low-threshold, inclusive, and informal interview process. Individuals from the community were encouraged to ‘apply’ with no formal application process, only verbal communication through community members sufficed. The informal interviews were conducted at the project site with community members. Prospective candidates were assessed for their passion and interest in community well-being; prior experience in similar community-based projects was optional. The PROUD project conducted at the same site demonstrated tobacco inequity (96% vs. 9-12% smoking rates) in this population, and in light of the findings of that study and particular characteristics of the population we ensured that the research question on tobacco dependence management was relevant to the applicants. Furthermore, a partnership between community researchers and academics was formed and regular meetings were held throughout the project.
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All members of the team (including community researchers) participated in the design of the project and questionnaires, including item development, development of strategies for recruitment and retention using a social network approach, data entry, data cleaning, data analysis, preparation of posters/abstracts/handouts, and manuscript preparation and knowledge mobilization. The complete details of the citizen/patient/peer engagement in the PROMPT project, ‘The Ottawa Citizen Engagement and Action Model’ (OCEAM), have been described in detail in another publication.(15) The community researchers underwent intensive training prior to participant enrollment. This training mainly focused on privacy, confidentiality, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, harm reduction, the role of peer interviewers, interviewing skills, obtaining study consent from participants, administering surveys with iPads, and administering lung function testing and certification for hand-held spirometry and oscillometry. Community researchers were given an honorarium ($15/hour) for their time spent conducting project related activities such as trainings, meetings, consenting, follow-ups, social networking for recruitment and retention, knowledge mobilization and data cleaning and analysis. At the baseline visit community researchers acquired consent, administered iPad based baseline questionnaires, two point-of-care lung function tests, hand-held spirometry and oscillometry. Community researchers also administered a monthly iPad based follow-up survey for six months ending with the administration of hand-held spirometry and oscillometry at the last follow-up. Participants were given $20 at the baseline enrollment and $25 at each monthly visit to compensate for their time and effort.
The structure of our recruitment strategy, interviewing and point-of-care testing, closely followed the principles of community-based research. As pairs, community researchers conducted street-based recruitment five days a week assessing eligibility and providing appointment times for enrolment, either on the same day or as per the potential participants’ convenience. Coercion for participation was avoided by pairing of community researchers and through rigorous ethics training. The consent process was conducted at the community research office, followed by a 45-minute one-on-one interview with community researchers using direct data entry through an iPad survey. After the training, community researchers created a handy list of project requirements which they posted in all interview rooms in order to adhere to project protocol and procedures. They also did their best, throughout the life of the project, to navigate their social networks to encourage participants to attend life-skills workshops, nurse counselling, and monthly follow-up appointments. All participants were enrolled in the Smoking Treatment for Ontario Patients (STOP) program led by the Centre for Addiction and Mental Health (CAMH), Toronto, in order to receive free and ‘off-label’ Nicotine Replacement Therapy (NRT). After consenting for the PROMPT project, participants met with an expert tobacco dependence treatment nurse from the Ottawa chapter of the Canadian Mental Health Association (CMHA). The CMHA nurse was specifically hired for the PROMPT project and was available onsite twice a week to offer one-on-one counseling and individualized NRT available through the STOP program. The participants could meet the nurse as frequently as requested by the participant or as deemed clinically necessary by the nurse. Expired CO was measured during the visits with the nurse with a Bedfont Micro Smokerlyzer Carbon Monoxide (CO) monitor (Bedfont Technical Instruments Ltd,
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Sittingbourne, Kent, United Kingdom) for biochemical confirmation of self-reported quitting. We followed the current clinical practice of the Canadian Mental Health Association to prescribe and dispense the amount of NRT titrated to suppress nicotine cravings. This could be refereed as "off-label" use of NRT, because the standard prescription of NRT, especially of nicotine patches, is titrated according to the number of daily cigarettes used. To further involve the community, weekly peer-led life skills workshops were conducted on a variety of topics such as financial literacy, banking, peer-support, HIV/Hepatitis C education, pet-care, cooking, mindfulness and art. The topics for these weekly workshops were generated by the community researchers and participants. Community researchers took the lead on organizing and conducting these workshops, in order to create a ‘safe space’ for participants, so that they do not feel intimidated. Volunteers from community organizations such as the Community Veterinary Outreach and Centre-ebo, Financial Education Centre, Ottawa helped facilitate some of the life-skills workshops. In addition, quarterly Community Knowledge Forums were designed and conducted by community researchers and project participants. These knowledge mobilization forums helped disseminate project outcomes and were attended by PROMPT participants, neighborhood community members and healthcare allies and occasionally by the local media, the Ottawa Police, and members of the provincial parliament.(25) PROMPT project related activities were exclusively conducted at a Community Research Centre, near the largest homeless shelter in Ottawa, located downtown in Ottawa’s popular ByWard market which is at the centre of open drug consumption and homelessness. A Community Advisory Committee (CAC) was formed at the centre with five voting members (PROMPT community researchers and participants) and five non-voting members from neighborhood community healthcare agencies with balanced sex, gender, race, language and indigenous representation. The CAC members were selected through an adaptation of the process used to select the PROMPT project’s community researchers. Community researchers reached out to the community to select and interview potential CAC members. The CAC meets monthly and the members named the Centre appropriately as the Bridge Engagement Centre (the Bridge), a place to bridge gaps between different communities. Data and measures: The participants underwent an expired carbon monoxide (CO) test, spirometry, and an oscillometry test at baseline and at the end of the project, 6 months after enrollment. Seven questionnaires were administered by the community researchers to all participants at baseline: 1) demographic information: detailed tobacco smoking history, drug use questionnaire and the social network questionnaire (all questionnaires designed with community researchers), 2) Fagerstorm Test for Nicotine Dependence (FTND),(26) 3) the BOLD core questionnaire used in the CanCOLD study which aims to evaluate respiratory symptoms (cough, phlegm, whistling/wheezing, shortness of breath),(27,28) 4) Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT): an open-access disease-specific questionnaire,(29) 5) EQ-5D-3L: a well-validated five item questionnaire which measures generic quality of life (30), 6) Patient Health Questionnaire (PHQ-8): an eight-item open-access questionnaire which is used to establish provisional depressive disorder diagnoses as well as grade depressive symptom severity,(31) and 7) the Generalized Anxiety Disorder (GAD) questionnaire, a 7-item questionnaire to assess generalized anxiety disorder.(15–21) A brief follow-up questionnaire was
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administered by the community researchers at monthly follow-ups, pertaining to questions regarding current tobacco smoking status and the barriers and facilitators of smoking. A questionnaire was administered by the community researchers at 6 months to inquire about the overall experience with the project as well as the changes and challenges in tobacco smoking and poly-substance use experienced over the course of the project. All project related materials, including the consent form were in English. Language fluency was not formally assessed in participants with other than English as a first language. PHQ-8: Substance use disorders and depression often occur simultaneously within the same individual.(32) To assess the prevalence and impact for this cohort, an eight-item version of the Patient Health Questionnaire (PHQ-8) was used. The PHQ-8 consists of eight items on which the DSM-IV diagnosis of depressive disorders is based. Each participant answers the 8 questions with four responses (not at all to nearly every day (0 to 3)) assigned to each category. The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 0-4 represents no significant depressive symptoms; 5-9 mild depressive symptoms; 10-14, moderate; 15-19, moderately severe; and 20-24, severe.(33) GAD-7: The Generalized Anxiety Disorder 7-Item (GAD-7) questionnaire is a self-administered one-dimensional scale to assess the presence of the symptoms of generalized anxiety disorder (GAD) referred to in the DSM-IV. The score for each of 7 items ranges from 0 (not at all) to 3 (nearly every day), with a possible total score of 0 to 21. The total score may be categorized into four severity groups: minimal/no anxiety (0–4), 2) mild (5–9), 3) moderate (10–14), or severe (15–21) with an optimum cut-off value for GAD at 10 points.(34) EQ-5D-3L: One of the most frequently applied general health status measures is the EuroQol questionnaire (EQ-5D-3L). The EQ-5D-3L is a brief questionnaire used to evaluate the health related quality of life for this cohort.(35) The questionnaire consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression - which provides a single index value for health status for each individual.(36) The participants were also given a visual analogue scale (EQ-VAS) and asked to rate their health on a 20 cm vertical scale that ranges from 0-100, with 0 representing ‘the worst health you can imagine’ and 100 representing ‘the best health you can imagine’.(36)
Statistical analyses
Statistical analyses were performed using SAS version 9.3. Descriptive statistics were computed to provide an understanding of the population characteristics and distribution of the main study variables. A retention rate of 40% with full data collection at 6 month follow-up was considered to be adequate for the project to be considered feasible, a priori. Paired t-tests were conducted to compare baseline and study end (six month) outcomes of tobacco smoking per day, and between the first and last month of follow-up for illicit substance use. Baseline illicit substance use was not available because the initial survey asked for drug use ever and not current use. Follow-up data collection captured current illicit substance use. A multiple comparison correction was not necessary as only one test was conducted per study variable. We employed an Intention-To-Treat (ITT) analysis a priori, as we were expecting losses to follow-up.
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Between March and August 2016, the community researchers recruited, consented and completed baseline assessments on 80 participants. The baseline characteristics of these participants are presented in Table 1. Most participants were male (70%), Caucasian (77.5%), and between the ages of 41 and 50, with many participants having completed their high school education (31.3%), 26.3% starting higher education, and 5.0% completing college or university degrees. A larger proportion of participants had an average monthly income between $1000-$1999 and with most reporting some level of food insecurity. Majority reported English as a first language, and other participants were felt to be satisfactorily fluent in spoken and written English by the project staff. There was no significant difference in baseline demographic data between participants who were followed to project end (n=34) relative to participants lost to follow-up.
Table 1: Demographic characteristics (n=80)
Participant Characteristics Baseline (N=80) Study End (N=34) Loss to Follow-Up
(N=46)
Gender
Male Female
70.0% 30.0%
59% 41%
78% 22%
Age
16-30 31-40 41-50 51-65 N/A
14.8% 8.7% 44.4% 30.9% 1.2%
12% 6% 41% 41% 0%
17% 11% 48% 24% 0%
Ethnicity:
Caucasian: First Nations: Inuit: Métis**: East Asian: Other:
77.5% 16.3% 1.2% 1.2% 1.3% 2.5%
71% 20% 0% 3% 3% 3%
83% 15% 2% 0% 0% 2%
Education
Grade School/Some High School High School Graduate/GED Some College or University College/University Completed None N/A
33.7% 31.3% 26.3% 5.0% 1.2% 2.5%
35% 32% 24% 6% 3% 0%
33% 31% 29% 4% 2% 1%
Monthly Income
<$499 $500-$999 $1000-$1999 $2000-$2999 N/A
11.3% 33.7% 43.8% 10.0% 1.2%
6% 29% 56% 9% 0%
15% 37% 35% 11% 2%
Food Insecurity
Always Most of the time Occasionally Sometimes Usually Never N/A*
15.0% 11.2% 16.3% 26.2% 10.0% 18.8% 2.5%
18% 6% 12% 26% 9% 29% 0%
13% 15% 20% 26% 11% 11% 4%
*N/A=missing or refuse to answer; ** Métis - are a group of peoples in Canada who trace their descent to First Nations peoples and European settlers. They represent the majority of those identifying as Métis, though smaller communities also exist in the United States. They are recognized as one of Canada's aboriginal or indigenous peoples under the Constitution Act of 1982, along with First Nations and Inuit peoples.
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In Table 2, baseline information regarding self-reported health conditions, smoking and drug use related data for project participants is provided. Most participants at baseline smoked between 15-25 cigarettes daily for a period of 21-30 years, and many bought company branded cigarettes from convenience stores. However, over half of the participants also bought contraband cigarettes from a local dealer and the majority reported using crack and marijuana in their lifetime. Table 2. Baseline tobacco smoking, self-reported health conditions and poly-substance use (N-80)
Participant Characteristics Baseline (N=80) Study End (N=34) Loss to Follow-Up (N=46)
Supplementary Table 1 demonstrates the frequency of depressive symptoms as measured by the PHQ-8, generalized anxiety symptoms as measured by GAD-7 and the generic quality of life as measured by the EQ-5D-3L visual analogue scale. Mild anxiety was estimated to be present in 30% of participants and 32.6% of participants had moderate to severe anxiety scores. Mild depressive symptoms were present in 20% of participants and moderate to severe depression symptoms were present in 15% of participants. Mean EQ-5D-3L Visual Analog Scale was 62.2, with a standard deviation of 17. Supplementary Table 2 shows that the majority of participants accessed at least two types of nicotine replacement therapy (NRT) of the four types of NRT available in the project: the gum, lozenge, inhaler, and patch. While it is expected that participants that followed to study end accessed the most NRT and visited the nurse most often, the costs associated with both the NRT accessed and the visits to the nurse are not substantially greater than the costs associated with participants lost to follow-up. Supplementary Table 3 provides changes in self-reported tobacco smoking and poly-substance use over the six month follow-up. Participants smoked an average of 20.5 cigarettes at baseline in comparison to 9.3 cigarettes at the 6 months follow-up, with an average reduction of 11.2 cigarettes (p=.0001). Participants reported significant reductions in illicit substance use (18.8%. p=0.0011) between baseline and study-end, including a reduction in the opioids heroin (6.3%, p=0.0241), fentanyl (2.6%), and oxycontin (3.8%). Drug use data reporting was not uniform e.g. some participants had reported the use of crack in dollar figures where as others had reported in grams. Community researchers helped us translate the dollar figure and grams data in order to create harmonized data for analysis.
Figure 1 demonstrates the frequency of participants following up at monthly follow-up visits. Despite missing appointments, all participants were encouraged to come to the centre. Community researchers mobilized their social networks to encourage attendance at the follow-up visits. Feedback from participants and community researchers indicated two main reasons for loss to follow up: first, the follow-up rate would have been better had we provided participants with either transportation or food for the weekly life-skills workshops. It was not possible to provide such support due to funding constraints. Second, we also lost participants to incarceration as this community is subject to higher rates of enforcement for petty crimes and low level drug trafficking and are often targeted by "drug sweeps" before key tourism seasons in Ottawa, the capital city of Canada.
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Figures 2 and 3 demonstrate self-reported data from 34 participants at six months regarding changes in smoking and poly-substance use. Tobacco smoking quit rate was defined as biochemically-validated 7-day point prevalence smoking abstinence prevalence at the 6-month follow-up visit. Reduced use for cigarettes smoking and other drug use were defined as a self-reported reduction since project enrolment and/or the last follow-up visit. Data about tobacco use and drug use was collected at the same time point at the monthly follow-up visits and at the final 6-month post project survey. At around the 2nd month follow-up mark, the community researchers were a bit overwhelmed as there were too many participants at a time for their monthly follow-up visits. Hence, the project coordinator (TK) tried to help out by administering a few monthly follow-up iPad surveys. However, community researchers quickly noticed that when the project coordinator (TK) conducted the monthly follow-up interview, the self-reported drug use was less than when they conducted the interviews. Hence, a decision was made that only community researchers would conduct the monthly follow-up interviews and not the project coordinator. Out of the total recruited participants (n=80), 32.5% (p=0.0001) reported reducing their tobacco use while 18.8% (p=0.0011) reported reducing their poly-substance use, since the beginning of the program with ITT. Figure 2: Poly-substance use and tobacco smoking at the 6 month follow-up visit
0%
5%
10%
15%
20%
25%
30%
35%
Quit Reduced Same Increased
Substance use
Smoking
Poly-substance use
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Figure 3: Poly-substance use trend over six months
Supplementary Figure 1 provides the frequency of participants who reported having problems within each dimension of EQ-5D-3L. Approximately 24.4% of the participants reported problems with mobility, 6.3% with self-care, 15.2% with usual activities, 62.0% with pain, and 55.7% with anxiety. The average EQ-VAS score was 62.2 with a range of 3-100.(36)
Supplementary Figure 2 shows the reduction of cigarette use, paralleled by a reduction in
exhale CO levels measured at each participant follow-up over the full study period (11.2 cigarettes, p=0.0001). Exhale CO monitoring served as biochemical feedback for participants and as objective data on smoking cessation for the project.
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Discussion & Conclusion The PROMPT project was a Community-Based Participatory Action project with a longitudinal cohort study design that describes the detailed socio-economic variables associated with tobacco smoking and poly-substance use in the most at-risk marginalized inner city population of Ottawa (Canada). The project demonstrated that a comprehensive program focussed on tobacco dependence management available in a community and implemented in a true partnership with community (peer) researchers is feasible and can produce outcomes beyond tobacco smoking reduction or cessation. In the PROMPT cohort, participants at baseline smoked an average of 20.5 cigarettes per day. However, with time mean cigarette use reduced significantly (9.3, p=0.0001) in the majority of the participants (see figure 2). Smoking reduction is known to lead to smoking cessation (37), and hence we think that with a longer duration of support, a higher percentage of smoking cessation would have been achieved in our cohort. Moreover, a sizeable number of participants at study end self-reported a reduction and in some cases cessation of other poly-substance use (18.8%, p=0.0011) (see figure 3). Within opioid use a considerable reduction of heroin use (6.3%, p=0.0241) was observed, in addition to a reduction in the use of fentanyl (2.6%) and OxyContin (3.8%). Qualitative findings show that PROMPT participants experienced considerable psycho-socio-economic benefits such as better health (weight gain, improved breathing and physical exercise, enrollment in drug treatment etc.) and social outcomes (e.g. returning to work force, moving to a better place to live, reunification with family, greater community engagement etc.). Overall qualitative findings reveal that the quality of life of a third of the participants improved significantly. The following quotes speak to the changes in quality of life experienced by PROMPT participants:
“Now that I am smoking so less, I did not have to sneak behind my grandkids when I
went to play with them over the weekend. Else, I always had to make up a story and sneak
out hurriedly to take a few puffs, because the cravings were so bad. I had no cravings this
weekend and played for the full four hours with my grandkids, felt so good.” (Participant 1) “My chronic back pain is so much better now that I am smoking only 2-3 cigarettes.” (Participant 2) “I didn’t realize that smoking had such a large affect on my breathing and general
health. Now that I think about it everyone who smokes crack or uses [other illicit
substances such as heroin, fentanyl, cocaine etc.] also smokes cigarettes”.(Participant 3) It is well known that socioeconomic status in a society influences one’s health and well-being. Groups that have been traditionally disadvantaged, such as inner city populations tend to have high rates of tobacco smoking. (8) Furthermore, smoking rates have been declining in Canada, the US and among other high-income countries; however the decline has been slower or nonexistent among low SES groups. Health interventions such as PROMPT tackle social determinants of health that facilitate substance use and poor health. The wide-ranging benefits (e.g. return to work, improved social capital, seeking out health care etc.) of holistic interventions can contribute considerably to the reduction of disparities in morbidity and mortality in marginalized communities with an estimated economic value of $1.02 trillion (38).
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In clinical settings, tobacco use is strongly associated with poly-substance use.(13) The neurobiology of addiction demonstrates that tobacco may have the strongest physiological pull and thus may be the most difficult to quit. Addiction research speaks to the entangled nature of tobacco and poly-substance use strengthened by shared neurobiological processes that trigger dopamine release in the reward pathway of the brain creating pleasure and an additive effect that enhances enjoyment and dependence.(39) Adolescent research and animal studies confirm the ‘gateway to illicit drugs’ hypothesis that suggests the introduction of tobacco at an early age increases the likelihood of future illicit drug use.(40-42) Moreover, epidemiological research on addiction reveals better treatment and recovery outcomes for poly-substance users that quit tobacco use in comparison to counterparts that continue to smoke tobacco.(43-45) The above findings in the literature were evident in the many testimonials of community researchers and project participants throughout the PROMPT project. At one of the PROMPT community knowledge forums, one participant said, “For me, it was not so hard to quit crack, cocaine and
even heroin, but this beast is just so tough!” referring to cigarette smoking with his hand gesture. Tobacco use reduction and quitting leading to the reduction and quitting of other poly-substance use (as seen in PROMPT participants) is thus neuro-biologically plausible.(1) Studies in various clinical populations have reported high rates of tobacco use among persons with depression and anxiety. (46) According to research, current smokers were 2.5 times more likely to have an anxiety disorder; however, if they were former smokers there is no significant difference in the odds of having an anxiety disorder. (46) As noted in the PROMPT cohort, 30.0% reported mild anxiety, 18.8% reported moderate anxiety, and 13.8% reported severe anxiety (see supplementary table 3). According to Statistics Canada, the lifetime prevalence of GAD in the general population is approximately 5% in Canada.(47) Furthermore, the high comorbidity of anxiety and depressive disorders and the high correlation between depressive and anxiety measures is well known. Not surprisingly, our depression measure, the PHQ-8, strongly correlated with the GAD-7 and therefore in the PROMPT cohort we observed that 37.5% had mild depressive symptoms, 20.0% had moderate depressive symptoms, and 12.5 and 1.25% had moderately severe and severe depressive symptoms, respectively (see supplementary table 3).(31) There is no dearth of literature that documents that both neurobiological and psychosocial factors reinforce the use of nicotine in people with psychiatric illnesses (48;49). For individuals with chronic mental illness, smoking is a major part of their daily routine and is an activity that provides some structure and a sense of routine to a day with few activities.(48;49)
The PROMPT project utilized a community-based participatory approach with meaningful ‘patient engagement’ of community (peer) researchers that were truly representative of the study’s target population. The PROMPT community (peer) researchers were seen as confidants and were able to encourage participants by providing examples of their own struggles and the successes they experienced in their personal journeys to recovery. With complex social determinants of health at play in this population, the community-based participatory approach allowed PROMPT participants to develop social networks and enhance their knowledge of available community resources and supports. Furthermore, the participants found that the various community capacity building events and activities led by their peers were very helpful for their continued engagement and provided them additional support, if and when needed it. According to Davidson et al, peer support staffs are viewed more like friends than non-peer case managers or clinical staff for several reasons, a major one being that they share personal stories with the
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participants which allows for the development of social relationships. Furthermore, the relationships community (peer) researchers developed with participants were reciprocal as they both learned from each other and provided support to one another. (50) The impact of community based projects and peer to peer support in the project is revealed in the following quote by a PROMPT participant:
I really feel like I belong somewhere, I do not like to call it a program, it is a group.
Program feels like something forced upon you, this is so welcoming, I feel like coming
here and I get help.” (Participant 4)
Future research and additional programming is required to understand the mechanisms by which interventions such as PROMPT help marginalized hard-to-reach inner city populations. A community-based participatory action research approach, “by the people, for and with the
people”, is promising as it provides a novel approach to complex public health issues such as poverty and isolation leading to homelessness, tobacco smoking and poly-substance use. Marginalized populations need additional, personalized, holistic and peer-led support to reduce inequities in health. The holistic and compassionate approach designed and operationalized in PROMPT can be a part of the strategy dealing with the growing opioid crises in US and Canada (51). In addition, this strategy could be adapted for other complex and chronic health issues such as diabetes and obesity in different populations and in different settings including community-based integrated care. A service ally and leader of a neighbourhood agency said the following on the need for projects like PROMPT:
“PROMPT’s approach is so essential for this community as we see at our hospice that
almost all the beds are occupied by one or the other tobacco related end-stage diseases,
mostly lung cancers, it is so sad”. He also added that “We urgently need to know what
works”. (Service Ally and Social Services Executive Director)
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We are indebted to all of our PROMPT community researchers, without their trust in the academic research team and dedication towards harm reduction this project would not have been possible. PROMPT participants’ demonstrated resilience throughout the project; and despite their day-to-day struggles they kept coming for follow-ups - we are so very grateful for your inner strength. We thank Dr. Peter Selby and his team at the CAMH in Toronto, Canada for their belief in us and support with the STOP program. We are also thankful to the Ottawa chapter of CMHA for providing excellent nurses for our project. To our local healthcare allies: the Shepherds of Good Hope, Ottawa Inner City Health Inc., Sandy Hill Community Health Centre (CHC), Somerset West CHC - we could not have implemented the project without your in-kind support. Our Community Advisory Committee at the Bridge, comprised of K. McNaughton (Ottawa Inner City Health Inc.), R. Boyd (Oasis, Sandy Hill CHC), S. Willmott (Somerset CHC), J. Haddad (CMHA), S. Pakhale (PROMPT lead scientist), Tara, Rick, Ted and Petrina (PROMPT participants) and K. Florence (a PROMPT community researcher), meets monthly at the Bridge and guides the mission and vision of the space along with overseeing smooth functioning of all projects. We are indebted to the vision, dedication and passion of the CAC. We are thankful to the Ottawa Hospital, especially Dr. Jack Kitts, Dr. Jim Worthington, Dr. Jeff Turnbull, Dr. Mike Tierney, Dr. Bill Cameron, Dr. Ian Graham, Dr. Antoine Hakim and the administrative staff for administrative and moral support in maintaining our community space, the Bridge Engagement Centre. We thank the EuroQol questionnaire team (EQ-5D-3L) for allowing us to use the questionnaire pro-bono for this project.
No competing interests
Funding: This work was supported by the Champlain Local Health Integration Network, Department of Medicine and the Divisions of Respirology and Cardiology at the Ottawa Hospital, Ottawa, Canada. "All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work." All available data can be obtained by contacting the corresponding author.
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Table Legends Table 1: Demographic characteristics (n=80) Table 2: Baseline tobacco smoking, self-reported health conditions and poly-substance use Supplementary Table 1: Results from the baseline GAD-7, PHQ-8 and EQ-5D-3L questionnaires Supplementary Table 2: Access to Nicotine Replacement Therapy, Canadian Mental Health Association Nurse, and Associated Costs Supplementary Table 3: Mean cigarettes per day (CPD) and poly-substance use data at monthly follow-ups collected at the same time point (Intention-To-Treat Analysis)
Figure Legends
Figure 1: Frequency of participants following up monthly up to six months Figure 2: Poly-substance use and tobacco smoking at the 6 month follow-up visit Figure 3: Poly-substance use trend over six months Supplementary Figure 1: Frequency of participants reporting each dimension of the EQ-5D-3L at the baseline Supplementary Figure 2: Mean cigarettes per day and exhaled CO per month of six month study duration.
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Participants 13* (a) Report numbers of individuals at each stage of study—eg numbers potentially eligible, examined for eligibility,
confirmed eligible, included in the study, completing follow-up, and analysed 5-8
(b) Give reasons for non-participation at each stage 11-12
(c) Consider use of a flow diagram 12
Descriptive data 14* (a) Give characteristics of study participants (eg demographic, clinical, social) and information on exposures and
potential confounders 5-8
(b) Indicate number of participants with missing data for each variable of interest 9-14
(c) Cohort study—Summarise follow-up time (e.g., average and total amount) 9-14
Outcome data 15* Cohort study—Report numbers of outcome events or summary measures over time 9-14
Case-control study—Report numbers in each exposure category, or summary measures of exposure N/A
Cross-sectional study—Report numbers of outcome events or summary measures N/A
Main results 16 (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95%
confidence interval). Make clear which confounders were adjusted for and why they were included N/A
(b) Report category boundaries when continuous variables were categorized N/A
(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period N/A
Other analyses 17 Report other analyses done—eg analyses of subgroups and interactions, and sensitivity analyses N/A
Discussion
Key results 18 Summarise key results with reference to study objectives 15-17
Limitations 19 Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction
and magnitude of any potential bias 2, 15-17
Interpretation 20 Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results
from similar studies, and other relevant evidence 15-17
Generalisability 21 Discuss the generalisability (external validity) of the study results 15-17
Other information
Funding 22 Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on
which the present article is based 18
*Give information separately for cases and controls in case-control studies and, if applicable, for exposed and unexposed groups in cohort and cross-sectional studies.
Note: An Explanation and Elaboration article discusses each checklist item and gives methodological background and published examples of transparent reporting. The STROBE
checklist is best used in conjunction with this article (freely available on the Web sites of PLoS Medicine at http://www.plosmedicine.org/, Annals of Internal Medicine at
http://www.annals.org/, and Epidemiology at http://www.epidem.com/). Information on the STROBE Initiative is available at www.strobe-statement.org.
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Management and Point-of-Care for Tobacco Dependence (PROMPT): a feasibility mixed methods Community Based
Participatory Action Research project in Ottawa, Canada
Journal: BMJ Open
Manuscript ID bmjopen-2017-018416.R1
Article Type: Research
Date Submitted by the Author: 11-Sep-2017
Complete List of Authors: Pakhale, Smita; Ottawa Hospital; Ottawa Hospital Research Institute Kaur, Tina; Ottawa Hospital Research Institute Charron, Catherine; Department of Medicine in Ottawa; Ottawa Hospital
Florence, Kelly; The Bridge Engagement Centre Rose, Tiffany; The Bridge Engagement Centre Jama, Sadia; Ottawa Hospital Research Institute Boyd, Rob; Sandy Hill Community Health Centre Haddad, Joanne; Canadian Mental Health Association Ottawa Branch Alvarez, Gonzalo ; Ottawa Hospital; Ottawa Hospital Research Institute Tyndall, Mark; British Columbia Centre for Disease Control; University of British Columbia
<b>Primary Subject Heading</b>:
Addiction
Secondary Subject Heading: Public health, Smoking and tobacco, Health policy
Keywords:
Health policy < HEALTH SERVICES ADMINISTRATION & MANAGEMENT,
Public health < INFECTIOUS DISEASES, EPIDEMIOLOGY, SOCIAL MEDICINE
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Management and Point-of-Care for Tobacco Dependence (PROMPT): a feasibility mixed
methods Community Based Participatory Action Research project in Ottawa, Canada
Dr. Smita Pakhale, MD, MSc1,2,3*, Tina Kaur, MPH2, Dr. Catherine Charron, MD1,3, Kelly Florence4, Tiffany Rose4, Sadia Jama, MSc2, Robert Boyd, BSc5, Joanne Haddad, RN6, Dr. Gonzalo Alvarez, MD, MSc1,2,3, Dr. Mark Tyndall, MD, PhD7,8 1The Ottawa Hospital, Ottawa, Canada 2The Ottawa Hospital Research Institute (OHRI), Ottawa, Canada 3University of Ottawa, Ottawa, Canada 4Community (Peer) Researcher, the Bridge Engagement Centre, Ottawa, Canada 5Oasis, Sandy Hill Community Health Centre, Ottawa, Canada 6Canadian Mental Health Association, the Ottawa Branch, Canada 7British Columbia Centre for Disease Control, Vancouver, Canada 8University of British Columbia, Vancouver, Canada *Corresponding Author: Dr. Smita Pakhalé, MD, FRCPC, MSc (Epidemiology & Biostatistics) Associate Scientist - Ottawa Hospital Research Institute Assistant Professor - University of Ottawa Staff Respirologist - Division of Respiratory Medicine The Ottawa Hospital 501 Smyth Road Ottawa, Ontario, K1H 8L6 Canada Phone: 613-737-8899 Ex. 79428 Email: [email protected] http://www.ohri.ca/Profiles/pakhale.asp SP, KF, MT contributed to the conception and design of the study. SP, TK, KF, TR, CC, RB, and JH, made substantial contributions to the acquisition of the data, data entry, or data analysis and data interpretation. SP, TK, CC, KF, TR, SJ, RB, JH, and MT were all involved in the drafting of the manuscript or the revisions made to the manuscript. All authors have given final approval of the version of the manuscript submitted for publication, and agree to be accountable for all aspects of the work. Key Words: Tobacco dependence, patient engagement, opioid crises, community-based participatory action research, peer-led, drug use, substance use disorder Word Count: 8983
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Abstract Objective: To determine the feasibility of a Community-Based Participatory Tobacco-Dependence Strategy (PROMPT) in the inner city population of Ottawa (Canada). Design: A feasibility mixed methods prospective cohort study following principles of Community Base Participatory Action Research. Intervention: We recruited 80 people who use drugs, followed them for six months while providing access to counselling, nicotine replacement therapy and peer-support in a community setting. Setting: Community research office located in downtown Ottawa, adjacent to low-income housing, Ottawa shelter services, and street based drug consumption.
Primary Outcome: retention rate at 6-month follow up; Secondary Outcome: biochemically-validated 7-day point prevalence smoking abstinence at 26 weeks, defined as self-reported abstinence in the past 7 days with exhaled carbon monoxide ≤ 10 ppm. Results: The average age of participants’ was 43.8 years with a mean of 27.3 years of smoking. Participants were 70% male, 33.7% reported less than a high-school education, 21% identified as indigenous, and 43.8% reported an income between $1000-1999/month. Baseline mean daily cigarette use was 20.5 cigarettes and 9.3 cigarettes at study end with mean reduction of 11.2 cigarettes at six months (p=0.0001). The 6 month follow-up rate was 42.5%. Considerable reduction in other substance use was reported (18.8%, p=0.0011), including a reduction in the opioids heroin (6.3%, p=0.0241), fentanyl (2.6%), and oxycontin (3.8%). Study findings also reveal psycho-socio-economic benefits such as improved health, return to work, and greater community engagement. Conclusions: The PROMPT project describes socio-economic variables associated with tobacco and poly-substance use. A program focused on tobacco dependence, easily accessible in the community, and led by community peers with lived experience is feasible to implement and successful in supporting positive life changes. PROMPT’s patient engagement model is an effective harm-reduction strategy for the growing opioid use crisis and can improve the health outcomes of marginalized at-risk populations worldwide.
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Introduction Tobacco smoking is a leading preventable cause of morbidity and mortality in Canada and globally.(1) The effects of nicotine, the pharmacologically active agent in tobacco products, is acutely toxic as nicotine readily enters the body through the lungs and is distributed rapidly throughout the bloodstream.(1) Beyond the addictive properties of nicotine, it activates multiple biologic pathways that play a role in hampering fetal growth and development, the immune system, the cardiovascular system, and the central nervous system; in addition to stimulating carcinogenesis.(1) The life expectancy of tobacco smokers is cut short as smoking is documented to shorten life far more than most other risk factors for premature death; smokers are estimated to lose more than a decade of life in comparison to non-smokers.(1) Despite a steady decline in cigarette smoking since 1964, large disparities in rates of tobacco use remain evident across groups defined by race, ethnicity, educational level, and socioeconomic status (SES) and across regions in all high-income countries including Canada.(1-3) Major health disparities exist between smokers and non-smokers and are evident with lower socio-economic status groups having disproportionately higher rates of tobacco use.(4) Globally, disadvantaged groups between the ages of 35 and 69 are much more likely to die from tobacco smoking.(3;5) Tobacco is responsible for about half of the socioeconomic difference in death rates for this age range. (3;6) Specifically, smoking tobacco rates are higher among the long-term unemployed, homeless or at-risk for homelessness, mentally ill, prisoners, single parents, people with limited education, people with low income, and some groups of immigrants and ethnic minorities (7;8) which are more likely to be socioeconomically disadvantaged.(8-12) Poly-substance use and tobacco use are common co-occurrences in homeless or at-risk for homelessness populations in North America.(13) Although the city of Ottawa (Canada) has one of the lowest smoking rates in the Province of Ontario (9-12 %),(14;15) major disparities exist as disproportionately higher rates of tobacco smoking were observed among people who use drugs (PWUD). According to the PROUD (Participatory Research in Ottawa: Understanding Drugs) study of Ottawa inner city residents who use multiple drugs, 96 % of respondents reported they had smoked cigarettes in the past year.(15;16) Furthermore, similar trends are observed in the United States, for example 29% of the general population smoked in comparison to 75-100% for people who abuse alcohol, PWUD, and those receiving methadone maintenance. Many people recovering from poly-substance addictions die from smoking related illnesses.(17;18) Reducing the harm associated with cigarette smoking among lower SES groups creates opportunities for improving the health and well-being of disadvantaged communities, in addition to reducing the disproportionate burden of smoking related illness on the health care system.(11;19) A harm reduction paradigm emphasizes a pragmatic approach to substance use, removing moral judgement, and instead prioritizing health problems associated with substance abuse in order to reduce and minimize individual and societal consequences.(20) Moreover, a harm reduction approach acknowledges that many substance users may never achieve (or even have the desire to achieve) abstinence and that in light of this reality it is important to provide non-abstinence based alternatives to reduce exposure to risk and harm from substance misuse. (20) The success of harm reduction among illicit drug users carries over to tobacco harm reduction efforts, which in addition to a reduction in smoking also includes the use of nicotine replacement therapy (e.g. nicotine patch, gum, inhaler etc.). Among alternative nicotine products,
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nicotine replacement therapies are the least harmful with a marked reduction in cardiovascular disease and negligible carcinogenic risk or risk for acquiring respiratory disease.(21)
Mental illness is strongly associated with the initiation and maintenance of cigarette smoking. (22) Individuals with mental health issues smoke tobacco at an alarmingly high rate, and as a result experience an increased risk for smoking related illnesses. Smokers with mental health issues often start smoking at a younger age, are heavy smokers, and are less likely to participate and succeed in smoking reduction and cessation efforts. In particular, smoking is highly prevalent among individuals with anxiety and/or depression, who are more likely than individuals with other mental health issues to experience failed cessation attempts and relapse post-cessation.(22) Some studies propose a self-medication theory where individuals with mental health issues use substances to cope with their mental illness, while other studies suggest that smoking may act as a catalyst for the development of mental health issues. The opposite is also true as there is evidence that a reduction or cessation of smoking behaviour can improve the physical and mental health related Quality of Life (QOL) of smokers. One study in particular demonstrated a reduction in panic disorder and agoraphobia among quitters;(22) and another demonstrated that smokers were more likely to report poor physical and mental health related QOL when compared to non-smokers and former smokers.(23) Despite well-established benefits of tobacco harm reduction and smoking cessation,(1;24) common misconceptions exist when treating PWUD, for example that smoking cessation will interfere with drug dependence treatment by becoming an additional stressor. Health care providers may bring in their own biases and feel that smoking tobacco is not a priority issue in comparison to other substance use.(17) Yet, research shows that 44-80 % of PWUD are interested in quitting tobacco, 72 % of PWUD reported trying to quit tobacco smoking, and 69 % expressed interest in participating in a group smoking cessation program. Moreover, 82 % of PWUD indicated interest in receiving a prescription for nicotine replacement medication, and among those who considered cessation, approximately 56 % reported being interested in both group intervention and nicotine replacement.(24;25) Therefore, the motivation to quit smoking tobacco exists within the PWUD community - however there is a lack of programs designed to cater to at-risk, drug using, street based individuals. Very few research studies have followed poly-substance users and tracked their smoking activity as well as smoking cessation efforts. Importantly, with the growing crises of opioid use in the US and Canada, novel strategies to deal with the synchronicity of co-addictions are urgently needed.(26-28) Consequently, a community-based participatory action research project was conducted in the inner city population of Ottawa with PWUD.(15) The purpose of the project was to assess the feasibility of implementing a community-based participatory tobacco dependence strategy in Ottawa’s inner city. Feasibility centred outcomes include the impact of the project on the tobacco and poly-substance use of participants, the levels of loss to follow-up in a project that recruits active drug users, and the role of peer researchers in the implementation of the project and in the smoking cessation efforts of participants. Ultimately, the PROMPT project aims to demonstrate that a program focused on tobacco-dependence available in the community with meaningful ‘patient engagement’ of community members representative of the target population is feasible and able to improve quality of life and reduce tobacco use.
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The Participatory Research in Ottawa: Management and Point-of-Care for Tobacco Dependence (PROMPT) project was a feasibility mixed methods prospective cohort study with PWUD using a community-based participatory action model. The inclusion criteria was: 1) currently living in Ottawa for at least past 3 months prior to enrolment, 2) 16 years or older, 3) have used drugs in the past year (excluding marijuana and alcohol), and 4) had smoked tobacco in the past 7 days. The exclusion criteria for the study included: 1) consent declined (refusal from participant or decision maker); 2) any person accessing addictions treatment (in-patient drug rehabilitation) and hence unavailable for follow up; 3) any person currently or recently (in the past 30 days) enrolled in a smoking cessation program; and 4) anyone with a terminal illness with a life expectancy of less than 3 months. The Ottawa Health Science Network Research Ethics Board approved the study and written informed consent was obtained from all participants. Four individuals with lived experience, members of the PROMPT target population (ex/current tobacco smoker, homeless or at-risk for homelessness, poly-substance user), were selected as community (peer) researchers. The community researchers were selected through a low-threshold, inclusive, and informal interview process. The informal interviews were conducted at the project site with community members. Prospective candidates were assessed for their passion and interest in community wellbeing; prior experience in similar community-based projects was optional. A partnership between community researchers and academics was formed and regular meetings were held throughout the project. All members of the team (including community researchers) participated in the design of the project and questionnaires, including item development, development of strategies for recruitment and retention using a social network approach, data entry, data cleaning, data analysis, preparation of posters/abstracts/handouts, and manuscript preparation and knowledge mobilization. The com patient engagement approach used in the PROMPT project, ‘The Ottawa Citizen Engagement and Action Model’ (OCEAM), is described in detail in another publication.(15) The community researchers underwent intensive training prior to participant enrolment. The training focused on privacy, confidentiality, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, harm reduction, the role of peer interviewers, interviewing skills, obtaining study consent from participants, administering surveys with iPads, and administering lung function testing and certification for hand-held spirometry and oscillometry. After the training, community researchers created a list of project requirements that they posted in all interview rooms in order to adhere to the project’s protocol and procedures. Community researchers were given an honorarium ($15/hour) for the time spent conducting project related activities such as trainings, meetings, consenting, follow-ups, social networking for recruitment and retention, knowledge mobilization and data cleaning and analysis. Throughout the life of the project, community researchers also navigated their social networks to encourage participants to attend life-skills workshops, nurse counselling, and monthly follow-up appointments.
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The structure of the recruitment strategy, interviewing and point-of-care testing, closely followed the principles of community-based participatory action research. As pairs, community researchers conducted street-based recruitment five days a week assessing eligibility and providing appointment times for enrolment, either on the same day or as per the potential participants’ convenience. Coercion for participation was avoided by pairing of community researchers and through rigorous ethics training. At the baseline visit community researchers acquired consent, administered iPad based baseline questionnaires, two point-of-care lung function tests, and hand-held spirometry and oscillometry. The consent process was conducted at the community research office. Community researchers also administered a monthly iPad based follow-up survey for six months ending with the administration of hand-held spirometry and oscillometry at the last follow-up. Participants were given $20 at baseline enrolment and $25 at each monthly visit to compensate for their time and effort. All participants were enrolled in the Smoking Treatment for Ontario Patients (STOP) program led by the Centre for Addiction and Mental Health (CAMH), Toronto Branch, in order to receive free and ‘off-label’ Nicotine Replacement Therapy (NRT). After providing consent to participate in the PROMPT project participants met with an expert tobacco dependence treatment nurse from the Ottawa chapter of the Canadian Mental Health Association (CMHA). The CMHA nurse was specifically hired for the PROMPT project and was available onsite twice a week to offer one-on-one counselling and individualized NRT available through the STOP program. The participants could meet the nurse as frequently as requested by the participant or as deemed clinically necessary by the nurse. The study followed the current clinical practice of the Canadian Mental Health Association to prescribe and dispense the amount of NRT titrated to suppress nicotine cravings. This could be refereed as "off-label" use of NRT, because the standard prescription of NRT, especially of nicotine patches, is titrated according to the number of daily cigarettes used. The CMHA nurse provided brief counselling sessions (approximately 20 minutes) using motivational interviewing techniques and strategies to help participants strengthen their motivation to change and reduce their dependence on nicotine. The nurse and academic staff also supported participants in their efforts to access housing, health care services, and legal support by writing letters of support and connecting participants to community resources. Lastly, exhaled CO was measured during visits with the nurse using a Bedfont Micro Smokerlyzer for biochemical confirmation of self-reported quitting. To further involve the community, weekly peer-led life skills workshops were conducted on a variety of topics such as financial literacy, banking, peer-support, HIV/Hepatitis C education, pet-care, cooking, mindfulness meditation and art. Community researchers took the lead in organizing and conducting these workshops. Volunteers from community organizations helped facilitate some of the life-skills workshops. In addition, quarterly Community Knowledge Forums were designed and conducted by community researchers and project participants. The knowledge mobilization forums helped disseminate project outcomes and were attended by PROMPT participants, community members, healthcare service provider allies, and occasionally by the local media, the Ottawa Police, and members of the provincial parliament.(29). PROMPT project related activities were conducted at a Community Research Centre, near Ottawa’s largest homeless shelter, located downtown in Ottawa’s popular ByWard market which
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is at the centre of open drug consumption and homelessness. A Community Advisory Committee (CAC) was formed at the centre with five voting members (PROMPT community researchers and participants) and five non-voting members from neighbourhood community healthcare agencies with balanced sex, gender, race, language and indigenous representation. Community researchers reached out to the community to interview and select CAC members. The CAC meets monthly and the members named the Centre appropriately as the Bridge Engagement Centre (the Bridge), a place to bridge gaps between different communities.
Data and Measures
The participants underwent an expired carbon monoxide (CO) test, spirometry, and an oscillometry test at baseline and at the end of the project, 6 months after enrolment. Seven questionnaires were administered by the community researchers to all participants at baseline: 1) demographic information: detailed tobacco smoking history, drug use questionnaire and a social network questionnaire, 2) Fagerstorm Test for Nicotine Dependence (FTND),(30) 3) the BOLD core questionnaire used in the CanCOLD study which aims to evaluate respiratory symptoms (cough, phlegm, whistling/wheezing, shortness of breath),(31;32) 4) Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT): an open-access disease-specific questionnaire,(33) 5) EQ-5D-3L: a well-validated five item questionnaire which measures generic quality of life,(34) 6) Patient Health Questionnaire (PHQ-8): an eight-item open-access questionnaire which is used to establish provisional depressive disorder diagnoses as well as grade depressive symptom severity,(35) and 7) the Generalized Anxiety Disorder (GAD) questionnaire, a 7-item questionnaire to assess generalized anxiety disorder.(15–21) A brief follow-up questionnaire was administered by the community researchers at monthly follow-ups, pertaining to questions regarding current tobacco smoking status and the barriers and facilitators of smoking. The community researchers administered a questionnaire at 6 months to inquire about participants overall experience with the project as well as the changes and challenges in tobacco smoking and poly-substance use experienced over the course of the project. All project related materials, including the consent form were in English. PHQ-8: Substance use disorders and depression often occur simultaneously within the same individual.(36) To assess the prevalence and impact for this cohort, an eight-item version of the Patient Health Questionnaire (PHQ-8) was used. The PHQ-8 consists of eight items on which the DSM-IV diagnosis of depressive disorders is based. Each participant answers the 8 questions with four responses (not at all to nearly every day (0 to 3)) assigned to each category. The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0-4 represents no significant depressive symptoms; 5-9 mild depressive symptoms; 10-14 moderate; 15-19 moderately severe; and 20-24 severe.(37) GAD-7: The Generalized Anxiety Disorder 7-Item (GAD-7) questionnaire is a self-administered one-dimensional scale to assess the presence of the symptoms of generalized anxiety disorder (GAD) referred to in the DSM-IV. The score for each of 7 items ranges from 0 (not at all) to 3 (nearly every day) with a possible total score of 0 to 21. The total score may be categorized into four severity groups: minimal/no anxiety (0–4), 2) mild (5–9), 3) moderate (10–14), or severe (15–21) with an optimum cut-off value for GAD at 10 points.(38)
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EQ-5D-3L: One of the most frequently applied general health status measures is the EuroQol questionnaire (EQ-5D-3L). The EQ-5D-3L is a brief questionnaire used to evaluate the health related quality of life for this cohort.(39) The questionnaire consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression which provides a single index value for health status for each individual.(40) The participants were also given a visual analogue scale (EQ-VAS) and asked to rate their health on a 20 cm vertical scale that ranges from 0-100 with 0 representing ‘the worst health you can imagine’ and 100 representing ‘the best health you can imagine’.(40)
Data Analyses
The difficulty accessing the target population, the precarious nature of the target population’s living situation, and budget constraints determined the sample size. Potential confounders were included in the development of the study exclusion criteria. A retention rate of 40% with full data collection at the 6-month follow-up was considered adequate for the project to be considered feasible, a priori. As a result of the day-to-day challenges faced by the target population (e.g. housing instability, high incarceration rate, food insecurity, intermittent telephone access etc.) the study investigators estimated a high loss to follow-up, and decided a retention rate of at least 40% was reasonable and in line with the literature on high drop-out rates for smoking cessation projects and projects with low-income communities.(41;42) Other feasibility centered outcomes were based on monthly follow-up data, such as self-reported and biochemically validated tobacco use; the proportion of participants that participated in each follow-up; and the role of peer researchers on project implementation and impact. In particular, the variables used to measure both the primary and secondary outcome include cigarette use per day and exhaled CO as measured by a Bedfont Micro Smokerlyzer, respectively. The monthly follow-up questionnaire included open-ended questions, in order to get as much qualitative feedback as possible from participants. A thematic analysis was conducted as a means to identify recurring patterns (i.e. themes) in the data. The themes were determined not only by quantity but also quality in relation to study outcomes. Saturation was achieved when variation decreased, and no new themes developed in the data.
Statistical analyses were performed using SAS version 9.3. Descriptive statistics were computed to provide an understanding of the population characteristics and distribution of the main study variables. Paired t-tests were conducted to compare baseline and study end (six month) outcomes of tobacco smoking per day, and between the first and last month of follow-up for illicit substance use. Baseline illicit substance use was not available because the initial survey asked for drug use ever and not current use. Follow-up data collection captured current illicit substance use. A multiple comparison correction was not necessary as only one test was conducted per study variable. We employed an Intention-To-Treat (ITT) analysis a priori, as we were expecting losses to follow-up.
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Results Between March and August 2016, the community researchers recruited, consented and completed baseline assessments on 80 participants. The baseline characteristics of these participants are presented in Table 1. Most participants were male (70%), Caucasian (77.5%), and between the ages of 41 and 50. Many of the participants (31.3%) completed their high school education, some of the participants started higher education (26.3%), and a few (5.0%) completed college or university. A large proportion of participants had an average monthly income between $1000-$1999, with many reporting some level of food insecurity as measured by the frequency in which participants experienced hunger and were unable to afford food. Lastly, the majority of participants reported English as their first language. There was no significant difference in baseline demographic data between participants who were followed to project end (n=34) relative to participants lost to follow-up.
Table 1: Demographic characteristics (n=80)
Participant Characteristics Baseline %
(N=80)
Study End %
(N=34)
Loss to Follow-Up %
(N=46)
Gender
Male Female
70.0 30.0
59 41
78 22
Age
16-30 31-40 41-50 51-65 N/A
14.8 8.7 44.4 30.9 1.2
12 6 41 41 0
17 11 48 24 0
Ethnicity:
Caucasian: First Nations: Inuit: Métis**: East Asian: Other:
77.5 16.3 1.2 1.2 1.3 2.5
71 20 0 3 3 3
83 15 2 0 0 2
Education
Grade School/Some High School High School Graduate/GED Some College or University College/University Completed None N/A
33.7 31.3 26.3 5.0 1.2 2.5
35 32 24 6 3 0
33 31 29 4 2 1
Monthly Income
<$499 $500-$999 $1000-$1999 $2000-$2999 N/A
11.3 33.7 43.8 10.0 1.2
6 29 56 9 0
15 37 35 11 2
Food Insecurity
Always Most of the time Occasionally Sometimes Usually Never N/A*
15.0 11.2 16.3 26.2 10.0 18.8 2.5
18 6 12 26 9 29 0
13 15 20 26 11 11 4
*N/A=missing or refuse to answer; ** Métis - are a group of peoples in Canada who trace their descent to First Nations peoples and European settlers. They represent the majority of those identifying as Métis, though smaller communities also exist in the United States. They are recognized as one of Canada's aboriginal or indigenous peoples under the Constitution Act of 1982, along with First Nations and Inuit peoples.
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In Table 2, baseline information regarding self-reported health conditions, smoking and drug use related data for project participants is provided. Most of the participants at baseline smoked between 15-25 cigarettes daily for a period of 21-30 years, and purchased company branded cigarettes from convenience stores. However, over half of the participants also bought contraband cigarettes from a local dealer. The majority of participants reported using crack and marijuana in their lifetime. Table 2. Baseline tobacco smoking, self-reported health conditions and poly-substance use (N-80)
Participant Characteristics Baseline % (N=80) Study End % (N=34) Loss to Follow-Up %
Supplementary Table 1 demonstrates the frequency of depressive symptoms as measured by the PHQ-8, generalized anxiety symptoms as measured by GAD-7, and the generic quality of life as measured by the EQ-5D-3L visual analogue scale. Mild anxiety was estimated to be present in 30% of participants and 32.6% of participants had moderate to severe anxiety scores. Mild depressive symptoms were present in 20% of participants and moderate to severe depression symptoms were present in 15% of participants. Mean EQ-5D-3L Visual Analog Scale was 62.2, with a standard deviation of 17. Supplementary Table 2 shows that the majority of participants accessed at least two types of nicotine replacement therapy (NRT) of the four types of NRT available in the project: the gum, lozenge, inhaler, and patch. While it is expected that participants that followed to study end accessed the most NRT and visited the nurse most often, the costs associated with both the NRT accessed and the visits to the nurse are not substantially greater than the costs associated with participants lost to follow-up. Supplementary Table 3 provides changes in self-reported tobacco smoking and poly-substance use over the study’s six-month follow-up period. Participants smoked an average of 20.5 cigarettes at baseline in comparison to 9.3 cigarettes at the 6 month follow-up, with an average reduction of 11.2 cigarettes (p=.0001). Participants also reported significant reductions in illicit substance use (18.8%. p=0.0011) between baseline and study-end, including a reduction in the opioids heroin (6.3%, p=0.0241), fentanyl (2.6%), and oxycontin (3.8%). Drug use data reporting was not uniform for example some participants reported the use of crack in dollar figures whereas others reported in grams. Community researchers helped us translate the dollar figure and grams data in order to harmonized data for analysis.
Figure 1 demonstrates the frequency of participants following up at monthly follow-up visits. Community researchers mobilized their social networks to encourage attendance at follow-up visits. Feedback from participants and community researchers indicated two main reasons for loss to follow up: lack of transportation or food during follow-ups, and loss of participants to incarceration as the target community is subject to higher rates of enforcement for petty crimes and low level drug trafficking and are often targeted by "drug sweeps" before key tourism seasons.
Figures 2 and 3 demonstrate self-reported data from 34 participants at six months regarding changes in smoking and poly-substance use. Tobacco smoking quit rate was defined as biochemically-validated 7-day point prevalence smoking abstinence prevalence at the 6-month follow-up visit. Reduced use for cigarettes smoking and other drug use was defined as self-reported reduction since project enrolment and the last follow-up visit. Data about tobacco use and illicit drug use was collected at monthly follow-up visits and at the final 6-month post project survey. At around the 2nd follow-up, the community researchers were a bit overwhelmed with the number of participants at monthly follow-up visits. Hence, the project coordinator (TK) tried to help by administering a few monthly follow-up surveys. However, the community researchers quickly noticed that when the project coordinator (TK) conducted the monthly follow-up interview, the self-reported drug use was less than when they conducted the interviews. Hence, a decision was made that only community researchers would conduct the monthly follow-up interviews. Out of the total recruited participants (n=80), 32.5% (p=0.0001)
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reported reducing their tobacco use while 18.8% (p=0.0011) reported reducing their poly-substance use, since the beginning of the program with ITT. Supplementary Figure 1 provides the frequency of participants who reported having problems within each dimension of EQ-5D-3L. Approximately 24.4% of the participants reported problems with mobility, 6.3% with self-care, 15.2% with usual activities, 62.0% with pain, and 55.7% with anxiety. The average EQ-VAS score was 62.2 with a range of 3-100.(36) Supplementary Figure 2 shows the reduction of cigarette use, paralleled by a reduction in exhale CO levels measured at each participant follow-up over the full study period (11.2 cigarettes, p=0.0001). Exhale CO monitoring served as biochemical feedback for participants and as objective data on smoking cessation for the project. Several themes materialized from a thematic analysis of the qualitative data collected during the project’s six-month follow-up period. The first theme that emerged was regarding the role of peer researchers and their impact on participant outcome. Many of the participants believed their progress was due to the support they received from the project’s peer researchers. The peer researchers leadership and coordination of monthly follow-ups, outreach, and project related workshops’ helped create a sense of community and connection that many participants believe helped them manage their concurrent addictions. When asked what helped them reduce or quit, many of the participants mentioned the study’s community researchers:
“Felt well supported by Kelly and Tiffany” (Participant 1)
“Outreach by Kelly and Tiffany” (Participant 2)
Moreover, the impact of using a community based approach and peer-to-peer model is touched upon in the following quote by a PROMPT participant:
I really feel like I belong somewhere, I do not like to call it a program, it is a group.
Program feels like something forced upon you, this is so welcoming, I feel like coming
here and I get help.” (Participant 3)
Another theme that was present in the data captured the health benefits of smoking cessation. The following quotes speak to the changes in quality of life experienced by PROMPT participants, after reducing or quitting tobacco and other substances:
“Now that I am smoking less, I did not have to sneak out on my grandkids when I went to
play with them over the weekend. Else, I always had to make up a story and sneak out
hurriedly to take a few puffs, because the cravings were so bad. I had no cravings this
weekend and played for the full four hours with my grandkids, felt so good.”
(Participant 4)
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“My chronic back pain is so much better now that I am smoking only 2-3 cigarettes.” (Participant 5)
During the end of the study many of the participants started to make the connection between their smoking and other substance use:
“I didn’t realize that smoking had such a large effect on my breathing and general
health. Now that I think about it everyone who smokes crack or uses [other illicit
substances such as heroin, fentanyl, cocaine etc.] also smokes cigarettes.” (Participant 6) Finally, many of the participants reported that free access to personalized Nicotine Replacement Therapy (any combination and/or dose regiment) was helpful in their efforts to reduce or quit smoking tobacco:
“The NRT was helpful, especially being able to choose whatever mix I needed to help me
kick the habit” (Participant 7)
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Discussion & Conclusion The PROMPT project was a feasibility mixed methods prospective cohort study that describes the detailed psycho-socio-economic variables associated with tobacco smoking and poly-substance use in the most at-risk marginalized inner city population of Ottawa (Canada). The project demonstrated that a comprehensive program focussed on tobacco dependence management available in community and implemented in true partnership with community (peer) researchers is feasible (greater than 40% retention rate) and can produce outcomes beyond tobacco smoking reduction or cessation. In the PROMPT cohort, participants at baseline smoked an average of 20.5 cigarettes per day. However, with time mean cigarette use reduced significantly (9.3, p=0.0001) in the majority of the participants (see figure 2). Smoking reduction is known to lead to smoking cessation,(43) and thus a longer duration of support may well have produced a higher percentage of smoking cessation in the study cohort. Cessation was defined as smokers with exhaled carbon monoxide ≤ 10 ppm (see figure 2). Moreover, a sizeable number of participants at study end self-reported a reduction and in some cases cessation of other poly-substance use (18.8%, p=0.0011) (see figure 3). Within opioid use a considerable reduction in heroin use (6.3%, p=0.0241) was observed, in addition to a reduction in the use of fentanyl (2.6%) and OxyContin (3.8%). Participants that followed up the longest were more successful in reducing cigarette smoking and illicit substance use, and in improving their overall socioeconomic status, relative to participants who were lost to follow-up early in the project. Qualitative findings show that PROMPT participants experienced considerable psycho-socio-economic benefits such as better health (weight gain, improved breathing and physical exercise, enrolments in school and drug treatment etc.) and social outcomes (e.g. returning to work force, moving to a better place to live, reunification with family, greater community engagement, getting a pet etc.). Overall qualitative findings reveal that the quality of life of a third of the participants improved significantly; and that community based research involving peer-to-peer engagement holds the potential for improving health and meaningfully engaging marginalized communities in health research. It is well known that socioeconomic status in a society influences one’s health and wellbeing. Groups that have been traditionally disadvantaged, such as inner city populations tend to have high rates of tobacco smoking.(8) Furthermore, smoking rates have been declining in Canada, the US and among other high-income countries; however the decline has been slower or nonexistent among low SES groups. Health interventions such as PROMPT tackle social determinants of health that facilitate substance use and poor health. The wide-ranging benefits (e.g. return to work, improved social capital, seeking out health care etc.) of holistic interventions can contribute considerably to the reduction of disparities in morbidity and mortality in marginalized communities with an estimated economic value of $1.02 trillion.(44) This is especially important as the findings of the study show that the majority of participants are relatively young (see table 1) and have been smoking for at least 10 years (see table 2) putting them at high risk for chronic disease burden and many years of productive life lost. In clinical settings, tobacco use is strongly associated with poly-substance use.(13) The neurobiology of addiction demonstrates that tobacco may have the strongest physiological pull and thus may be the most difficult to quit. Addiction research speaks to the entangled nature of tobacco and poly-substance use strengthened by shared neurobiological processes that trigger
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dopamine release in the reward pathway of the brain creating pleasure and an additive effect that enhances enjoyment and dependence.(45) Adolescent research and animal studies confirm the ‘gateway to illicit drugs’ hypothesis that suggests the introduction of tobacco at an early age increases the likelihood of future illicit drug use.(46-48) Moreover, epidemiological research on addiction reveals better treatment and recovery outcomes for poly-substance users that quit tobacco use in comparison to counterparts that continue to smoke tobacco.(49-51) Tobacco use reduction and quitting leading to the reduction and quitting of other poly-substance use (as seen in PROMPT participants) is thus neuro-biologically plausible.(1) Studies in various clinical populations have reported high rates of tobacco use among persons with depression and anxiety.(52) According to research, current smokers were 2.5 times more likely to have an anxiety disorder; however, if they were former smokers there is no significant difference in the odds of having an anxiety disorder.(52) As noted in the PROMPT cohort, 30.0% reported mild anxiety, 18.8% reported moderate anxiety, and 13.8% reported severe anxiety (see supplementary table 3). According to Statistics Canada, the lifetime prevalence of GAD in the general population is approximately 5% in Canada.(53) Furthermore, the high comorbidity of anxiety and depressive disorders and the high correlation between depressive and anxiety measures is well known. Not surprisingly, our depression measure, the PHQ-8, strongly correlated with the GAD-7 and therefore in the PROMPT cohort we observed that 37.5% had mild depressive symptoms, 20.0% had moderate depressive symptoms, and 12.5 and 1.25% had moderately severe and severe depressive symptoms, respectively (see supplementary table 3).(35) There is no dearth of literature that documents that both neurobiological and psychosocial factors reinforce the use of nicotine in people with psychiatric illnesses.(54;55) For individuals with chronic mental illness, smoking is a major part of their daily routine and is an activity that provides some structure and a sense of routine to a day with few activities.(54;55)
The PROMPT project utilized a community-based participatory action approach with meaningful ‘patient engagement’ with community (peer) researchers that were truly representative of the study’s target population. The PROMPT community (peer) researchers were seen as confidants and were able to encourage participants by providing examples of their own struggles and the successes they experienced in their personal journeys to recovery. With complex social determinants of health at play in this population, the community-based participatory approach allowed PROMPT participants to develop social networks and enhance their knowledge of available community resources and supports. Furthermore, the participants found that the various community capacity building events and activities led by their peers encouraged their continued engagement and provided them additional support, if and when they needed it. According to Davidson et al, peer support staffs are viewed more like friends than non-peer case managers or clinical staff for several reasons, a major one being that they share personal stories with the participants which allows for the development of social relationships. Furthermore, the relationships community (peer) researchers developed with participants were reciprocal as they both learn from each other and provide support to one another.(56)
Future research and additional programming is required to understand the mechanisms by which interventions such as PROMPT help marginalized hard-to-reach inner city populations. A community-based participatory action research approach, “by the people, for the people”, is promising as it provides a novel approach to complex public health issues such as poverty and
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isolation leading to homelessness, tobacco smoking and poly-substance use. The PROMPT project’s patient centered, personalized, tailored approach to dispensing NRT and developing a quit plan and supports appropriate for active drug users is difficult to replicate in a clinical setting and necessitates a community based approach. The project’s success recruiting, engaging, and improving the health outcomes of a highly vulnerable hard-to-reach population surpassed initial expectations of feasibility and tobacco reduction and cessation. The impact of the project speaks to the need for additional, personalized, and holistic community based peer-led support to reduce health inequities in marginalized communities.(57) The PROMPT model’s holistic and compassionate approach can be also be used as part of the strategy dealing with the growing opioid crises in US and Canada.(58) Additionally, the model holds the potential to be adapted for other complex and chronic health issues such as diabetes and obesity in different populations and in different settings including community-based integrated care.
Study Limitations & Delimitations One limitation of the project was that it was conducted in one inner city setting. Nonetheless, many of the inner city populations across the US and Canada have a demographic profile similar to the participant profile in the PROMPT project. Thus, the project can be implemented in similar settings across the US and Canada. Furthermore, a larger study with a greater sample size will need to be conducted to demonstrate an effect on clinical outcomes. Lastly, while the findings are promising, the lack of a control limits the inferences that can be made from the study results. The PROMPT study was a mixed method feasibility study designed to lay the foundation for a Randomized Clinical Trial (RCT), and as such a control was not necessary. A plan is underway to conduct a multi-centre randomized control trial (RCT) to examine the impact and potential of the PROMPT model.
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Acknowledgments and Disclosures We are indebted to all of our PROMPT community researchers, without their trust in the academic research team and dedication towards harm reduction this project would not have been possible. PROMPT participants’ demonstrated resilience throughout the project; and despite their day-to-day struggles they kept coming for follow-ups, we are so very grateful for your inner strength. We thank Dr. Peter Selby and his team at the CAMH in Toronto, Canada for their belief in the PROMPT model and support through the STOP program. We are also thankful to the Ottawa chapter of CMHA for providing excellent nurses for our project. To our local healthcare allies: the Shepherds of Good Hope, Ottawa Inner City Health Inc., Sandy Hill Community Health Centre (CHC), Somerset West CHC, we could not have implemented the project without your in-kind support. Our Community Advisory Committee at the Bridge, comprised of K. McNaughton (Ottawa Inner City Health Inc.), R. Boyd (Oasis, Sandy Hill CHC), S. Willmott (Somerset CHC), J. Haddad (CMHA), S. Pakhale (PROMPT lead scientist), Tara, Rick, Ted and Petrina (PROMPT participants) and K. Florence (a PROMPT community researcher), meets monthly at the Bridge and guides the mission and vision of the space along with overseeing the smooth functioning of all projects. We are indebted to the vision, dedication and passion of the Bridge CAC. We are thankful to the Ottawa Hospital, especially Dr. Jack Kitts, Dr. Jim Worthington, Dr. Jeff Turnbull, Dr. Mike Tierney, Dr. Bill Cameron, Dr. Ian Graham, Dr. Antoine Hakim and the administrative staff for administrative and moral support in maintaining our community space, the Bridge Engagement Centre. We thank the EuroQol questionnaire team (EQ-5D-3L) for allowing us to use the questionnaire pro-bono for this project.
No competing interests
Funding: This work was supported by the Champlain Local Health Integration Network, Department of Medicine and the Divisions of Respirology and Cardiology at the Ottawa Hospital, Ottawa, Canada. "All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work." All available data can be obtained by contacting the corresponding author.
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(1) U.S.Department of Health and Human Services. The Health Consequences of Smoking-50 Years of Progress- A Report of the Surgeon General. http://wwwsurgeongeneral gov/library/reports/50-years-of-progress/exec-summary pdf 2014 [cited 2014 Sep 8];Available from:URL:http://www.surgeongeneral.gov/library/reports/50-years-of-progress/exec-summary.pdf
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(6) Jha P, Peto R, Zatonski W, Boreham J, Jarvis MJ, Lopez AD. Social inequalities in male mortality, and in male mortality from smoking: indirect estimation from national death rates in England and Wales, Poland, and North America. The Lancet 2006;368(9533):367-70.
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(14) Wielgosz A, Jaffey J, Williams K, Papadakis S, Simpson D, Dojeiji L. Champlain Cardiovascular Disease Prevention Network. Atlas of cardiovascular health in the Champlain region 2011. 2011.
(15) Pakhale S, Kaur T, Florence K, Rose T, Boyd R, Haddad J, et al. The Ottawa Citizen Engagement and Action Model (OCEAM): A Citizen engagement Strategy Operationalized Through The Participatory Research in Ottawa, Management and Point-of-care of Tobacco (PROMPT) Study. Research Involvement and Engagement 2016;2(1):1-18.
(16) Lazarus L, Shaw A, LeBlanc S, Martin A, Marshall Z, Weersink K. Establishing a community-based participatory research partnership among people who use drugs in Ottawa: the PROUD cohort study. Harm Reduction Journal 2014;11.
(17) Clarke JG, Stein MD, McGarry KA, Gogineni A. Interest in smoking cessation among injection drug users. The American Journal on Addictions 2001;10(2):159-66.
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(27) Gomes T. Ottawa must act quickly on opioid crisis. Toronto Star 2016Available from: URL: https://www.thestar.com/opinion/commentary/2016/09/06/ottawa-must-act-quickly-on-opioid-crisis.html
(28) Gershon L. Five Studies: Understanding America's Opioid Crisis. Pacific Standard 2016Available from:URL:https://psmag.com/five-studies-understanding-america-s-opioid-crisis-453cb1775a63#.ph3mvackk
(29) PROMPT quit smoking program helps butt out drug use. CBC News 2016Available from: URL: http://www.cbc.ca/news/canada/ottawa/prompt-quit-smoking-drug-program-1.3536743
(30) Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict 1991;86.
(31) Bourbeau J, Tan WC, Benedetti A, Aaron SD, Chapman KR, Coxson HO. Canadian Cohort Obstructive Lung Disease (CanCOLD): Fulfilling the Need for Longitudinal Observational Studies in COPD. COPD: J Chron Obstruct Pulmon Dis 2012;11.
(32) Buist AS, McBurnie MA, Vollmer WM, Gillespie S, Burney P, Mannino DM. International variation in the prevalence of COPD (The BOLD Study): a population-based prevalence study. Lancet 2001;370.
(33) Jones PW, Brusselle G, Dal Negro RW, Ferrer M, Kardos P, Levy ML. Properties of the COPD assessment test in a cross-sectional European study. Eur Respir J 2011;38.
(34) Simon Pickard A, Wilke C, Jung E, Patel S, Stavem K, Lee TA. Use of a preference-based measure of health (EQ-5D) in COPD and asthma. Respir Med 2008;102.
(35) Kroenke K, Spitzer RL, Williams JB. The PHQ-9: Validity of a Brief Depression Severity Measure. J Gen Intern Med 2001;16.
(36) Swendsen JD, Merikangas KR. The comorbidity of depression and substance use disorders. Clinical psychology review 2000;20(2):173-89.
(37) Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. Journal of affective disorders 2009;114(1):163-73.
(38) Ruiz MA, Zamorano E, Garc+¡a-Campayo J, Pardo A, Freire O, Rejas J. Validity of the GAD-7 scale as an outcome measure of disability in patients with generalized anxiety disorders in primary care. Journal of affective disorders 2011;128(3):277-86.
(39) van der Zanden BP, Dijkgraaf MG, Blanken P, de Borgie CA, van Ree JM, van den Brink W. Validity of the EQ-5D as a generic health outcome instrument in a heroin-dependent population. Drug and alcohol dependence 2006;82(2):111-8.
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(40) Tran BX, Ohinmaa A, Nguyen LT. Quality of life profile and psychometric properties of the EQ-5D-5L in HIV/AIDS patients. Health and Quality of life outcomes 2012;10(1):1.
(41) Belita E, Sidani S. Attrition in Smoking Cessation Intervention Studies: A Systematic Review. CJNR (Canadian Journal of Nursing Research) 2015;47(4):21-40.
(42) Courtney RJ, Clare P, Boland V, Martire KA, Bonevski B, Hall W, et al. Predictors of retention in a randomised trial of smoking cessation in low-socioeconomic status Australian smokers. Addictive Behaviors 2017;64:13-20.
smoking cessation: results from a double blind, randomized, placeboΓÇÉcontrolled trial of
nicotine gum with 2ΓÇÉyear followΓÇÉup. Addiction 2003;98(10):1395-402.
(44) Thornton RL, Glover CM, Cené CW, Glik DC, Henderson JA, Williams DR. Evaluating strategies for reducing health disparities by addressing the social determinants of health. Health Affairs. 2016 Aug1;35(8):1416-23.HealthAffairs20162016Availablefrom:URL: http://content.healthaffairs.org/content/35/8/1416.short
(45) Mendelsohn C, Wodak AM A. Smoking cessation in people with alcohol and other drug problems. Australian Family Physician 2016 Aug 1;45:569-73.
(46) Reed SC, Izenwasser S. Nicotine produces long-term increases in cocaine reinforcement in adolescent but not adult rats. Brain Research.
(47) McQuown S, Dao J, Belluzzi J, Leslie F. Differential behavioral and neurochemical effects of nicotine treatment in adolescent and adult rats. The FASEB Journal 2008;22(1_MeetingAbstracts):905-3.
(48) Corrigall WA. Nicotine self-administration in animals as a dependence model. Nicotine & Tobacco Research 1999 Mar 1;1(1):11-20.
(49) Weinberger AH, Funk AP, Goodwin RD. A review of epidemiologic research on smoking behavior among persons with alcohol and illicit substance use disorders. Preventive Medicine.
(50) Lemon SC, Friedmann PD, Stein MD. The impact of smoking cessation on drug abuse treatment outcome. Addictive Behaviors 2003 Sep;28(7):1323-31.
(51) Kohn CS, Tsoh JY, Weisner CM. Changes in smoking status among substance abusers: baseline characteristics and abstinence from alcohol and drugs at 12-month follow-up. Drug Alcohol Depend 2003 Jan 24;69(1):61-71.
(52) Degenhardt L, Hall W. The relationship between tobacco use, substance-use disorders and mental health: results from the National Survey of Mental Health and Well-being. Nicotine & Tobacco Research 2001;3(3):225-34.
(55) el-Guebaly N, Cathcart J, Currie S, Brown D, Gloster S. Smoking cessation approaches for persons with mental illness or addictive disorders. Psychiatric Services 2002.
(56) Rowe M, Bellamy C, Baranoski M, Wieland M, O'Connell MJ, Benedict P, et al. A peer-support, group intervention to reduce substance use and criminality among persons with severe mental illness. Psychiatric Services 2007.
(57) Wilson SR, Strub P, Buist AS, Knowles SB, Lavori PW, Lapidus J, et al. Shared treatment decision making improves adherence and outcomes in poorly controlled asthma. Am J Respir Crit Care Med 2010;181(6):566-77.
(58) Clarke H, Katz J. No quick fix to society's opioid crisis. Toronto Star 2016Available from: URL: https://www.thestar.com/opinion/commentary/2016/09/26/no-quick-fix-to-societys-opioid-crisis.html
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Table Legends Table 1: Demographic characteristics (n=80) Table 2: Baseline tobacco smoking, self-reported health conditions and poly-substance use Supplementary Table 1: Results from the baseline GAD-7, PHQ-8 and EQ-5D-3L questionnaires Supplementary Table 2: Access to Nicotine Replacement Therapy, Canadian Mental Health Association Nurse, and Associated Costs Supplementary Table 3: Mean cigarettes per day (CPD) and poly-substance use data at monthly follow-ups collected at the same time point (Intention-To-Treat Analysis)
Figure Legends
Figure 1: Frequency of participants following up monthly up to six months Figure 2: Poly-substance use and tobacco smoking at the 6 month follow-up visit Figure 3: Poly-substance use trend over six months Supplementary Figure 1: Frequency of participants reporting each dimension of the EQ-5D-3L at the baseline Supplementary Figure 2: Mean cigarettes per day and exhaled CO per month of six month study duration.
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Participants 13* (a) Report numbers of individuals at each stage of study—eg numbers potentially eligible, examined for eligibility,
confirmed eligible, included in the study, completing follow-up, and analysed 13
(b) Give reasons for non-participation at each stage 13
(c) Consider use of a flow diagram 13
Descriptive data 14* (a) Give characteristics of study participants (eg demographic, clinical, social) and information on exposures and
potential confounders 6
(b) Indicate number of participants with missing data for each variable of interest 10-11
(c) Cohort study—Summarise follow-up time (e.g., average and total amount) 7-9
Outcome data 15* Cohort study—Report numbers of outcome events or summary measures over time 10-15
Case-control study—Report numbers in each exposure category, or summary measures of exposure N/A
Cross-sectional study—Report numbers of outcome events or summary measures N/A
Main results 16 (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95%
confidence interval). Make clear which confounders were adjusted for and why they were included N/A
(b) Report category boundaries when continuous variables were categorized N/A
(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period N/A
Other analyses 17 Report other analyses done—eg analyses of subgroups and interactions, and sensitivity analyses N/A
Discussion
Key results 18 Summarise key results with reference to study objectives 17-19
Limitations 19 Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction
and magnitude of any potential bias 19
Interpretation 20 Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results
from similar studies, and other relevant evidence 17-19
Generalisability 21 Discuss the generalisability (external validity) of the study results 17-19
Other information
Funding 22 Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on
which the present article is based 20
*Give information separately for cases and controls in case-control studies and, if applicable, for exposed and unexposed groups in cohort and cross-sectional studies.
Note: An Explanation and Elaboration article discusses each checklist item and gives methodological background and published examples of transparent reporting. The STROBE
checklist is best used in conjunction with this article (freely available on the Web sites of PLoS Medicine at http://www.plosmedicine.org/, Annals of Internal Medicine at
http://www.annals.org/, and Epidemiology at http://www.epidem.com/). Information on the STROBE Initiative is available at www.strobe-statement.org.
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Management and Point-of-Care for Tobacco Dependence (PROMPT): a feasibility mixed methods Community Based
Participatory Action Research project in Ottawa, Canada
Journal: BMJ Open
Manuscript ID bmjopen-2017-018416.R2
Article Type: Research
Date Submitted by the Author: 25-Oct-2017
Complete List of Authors: Pakhale, Smita; Ottawa Hospital; Ottawa Hospital Research Institute Kaur, Tina; Ottawa Hospital Research Institute Charron, Catherine; Department of Medicine in Ottawa; Ottawa Hospital
Florence, Kelly; The Bridge Engagement Centre Rose, Tiffany; The Bridge Engagement Centre Jama, Sadia; Ottawa Hospital Research Institute Boyd, Rob; Sandy Hill Community Health Centre Haddad, Joanne; Canadian Mental Health Association Ottawa Branch Alvarez, Gonzalo ; Ottawa Hospital; Ottawa Hospital Research Institute Tyndall, Mark; British Columbia Centre for Disease Control; University of British Columbia
<b>Primary Subject Heading</b>:
Addiction
Secondary Subject Heading: Public health, Smoking and tobacco, Health policy
Keywords:
Health policy < HEALTH SERVICES ADMINISTRATION & MANAGEMENT,
Public health < INFECTIOUS DISEASES, EPIDEMIOLOGY, SOCIAL MEDICINE
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Management and Point-of-Care for Tobacco Dependence (PROMPT): a feasibility mixed
methods Community Based Participatory Action Research project in Ottawa, Canada
Dr. Smita Pakhale, MD, MSc1,2,3*, Tina Kaur, MPH2, Dr. Catherine Charron, MD1,3, Kelly Florence4, Tiffany Rose4, Sadia Jama, MSc2, Robert Boyd, BA5, Joanne Haddad, RN6, Dr. Gonzalo Alvarez, MD, MSc1,2,3, Dr. Mark Tyndall, MD, PhD7,8 1The Ottawa Hospital, Ottawa, Canada 2The Ottawa Hospital Research Institute (OHRI), Ottawa, Canada 3University of Ottawa, Ottawa, Canada 4Community (Peer) Researcher, the Bridge Engagement Centre, Ottawa, Canada 5Oasis, Sandy Hill Community Health Centre, Ottawa, Canada 6Canadian Mental Health Association, the Ottawa Branch, Canada 7British Columbia Centre for Disease Control, Vancouver, Canada 8University of British Columbia, Vancouver, Canada *Corresponding Author: Dr. Smita Pakhalé, MD, FRCPC, MSc (Epidemiology & Biostatistics) Associate Scientist - Ottawa Hospital Research Institute Assistant Professor - University of Ottawa Staff Respirologist - Division of Respiratory Medicine The Ottawa Hospital 501 Smyth Road Ottawa, Ontario, K1H 8L6 Canada Phone: 613-737-8899 Ex. 79428 Email: [email protected] http://www.ohri.ca/Profiles/pakhale.asp SP, KF, MT contributed to the conception and design of the study. SP, TK, KF, TR, CC, SJ, RB and JH made substantial contributions to the acquisition of the data, data entry, or data analysis and data interpretation. SP, TK, CC, KF, TR, SJ, RB, JH, GA and MT were all involved in the drafting of the manuscript or the revisions made to the manuscript. All authors have given final approval of the version of the manuscript submitted for publication, and agree to be accountable for all aspects of the work. Key Words: Tobacco dependence, patient engagement, opioid crises, community-based participatory action research, peer-led, drug use, substance use disorder Word Count: 9095
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Abstract Objective: To determine the feasibility of a Community-Based Participatory Tobacco-Dependence Strategy (PROMPT) in the inner city population of Ottawa (Canada). Design: A feasibility mixed methods prospective cohort study following principles of Community Base Participatory Action Research. Intervention: We recruited 80 people who use drugs, followed them for six months while providing access to counselling, nicotine replacement therapy and peer-support in a community setting. Setting: Community research office located in downtown Ottawa, adjacent to low-income housing, Ottawa shelter services, and street based drug consumption.
Primary Outcome: retention rate at 6-month follow up; Secondary Outcome: biochemically-validated 7-day point prevalence smoking abstinence at 26 weeks, defined as self-reported abstinence in the past 7 days with exhaled carbon monoxide ≤ 10 ppm. Results: The average age of participants’ was 43.8 years with a mean of 27.3 years of smoking. Participants were 70% male, 33.7% reported less than a high-school education, 21% identified as indigenous, and 43.8% reported an income between $1000-1999/month. Baseline mean daily cigarette use was 20.5 cigarettes and 9.3 cigarettes at study end with mean reduction of 11.2 cigarettes at six months (p=0.0001). The 6 month follow-up rate was 42.5%. Considerable reduction in other substance use was reported (18.8%), including a reduction in the opioids heroin (6.3%), fentanyl (2.6%), and oxycontin (3.8%). Study findings also reveal psycho-socio-economic benefits such as improved health, return to work, and greater community engagement. Conclusions: The PROMPT project describes socio-economic variables associated with tobacco and poly-substance use. A program focused on tobacco dependence, easily accessible in the community, and led by community peers with lived experience is feasible to implement and successful in supporting positive life changes. PROMPT’s patient engagement model is an effective harm-reduction strategy for the growing opioid use crisis and can improve the health outcomes of marginalized at-risk populations worldwide.
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Introduction Tobacco smoking is a leading preventable cause of morbidity and mortality in Canada and around the world.(1) The effects of nicotine, the pharmacologically active agent in tobacco products, is acutely toxic as nicotine readily enters the body through the lungs and is distributed rapidly throughout the bloodstream.(1) Beyond the addictive properties of nicotine, it activates multiple biologic pathways that play a role in hampering fetal growth and development, the immune system, the cardiovascular system, and the central nervous system; in addition to stimulating carcinogenesis.(1) The life expectancy of tobacco smokers is cut short as smoking is documented to shorten life far more than most other risk factors for premature death; smokers are estimated to lose more than a decade of life in comparison to non-smokers.(1) Despite a steady decline in cigarette smoking since 1964, large disparities in rates of tobacco use remain evident across groups defined by race, ethnicity, educational level, and socioeconomic status (SES) and across regions in all high-income countries including Canada.(1-3) Major health disparities exist between smokers and non-smokers and are evident with lower socio-economic status groups having disproportionately higher rates of tobacco use.(4) Globally, disadvantaged groups between the ages of 35 and 69 are much more likely to die from tobacco smoking.(3;5) Tobacco is responsible for about half of the socioeconomic difference in death rates for this age range. (3;6) Specifically, smoking tobacco rates are higher among the long-term unemployed, homeless or at-risk for homelessness, mentally ill, prisoners, single parents, people with limited education, people with low income, and some groups of immigrants and ethnic minorities (7;8) which are more likely to be socioeconomically disadvantaged.(8-12) Poly-substance use and tobacco use are common co-occurrences in homeless or at-risk for homelessness populations in North America.(13) Although the city of Ottawa (Canada) has one of the lowest smoking rates in the Province of Ontario (9-12 %),(14;15) major disparities exist as disproportionately higher rates of tobacco smoking were observed among people who use drugs (PWUD). According to the PROUD (Participatory Research in Ottawa: Understanding Drugs) study of Ottawa inner city residents who use multiple drugs, 96 % of respondents reported they had smoked cigarettes in the past year.(15;16) Furthermore, similar trends are observed in the United States, for example 29% of the general population smoked in comparison to 75-100% for people who abuse alcohol, PWUD, and those receiving methadone maintenance. Many people recovering from poly-substance addictions die from smoking related illnesses.(17;18) Reducing the harm associated with cigarette smoking among lower SES groups creates opportunities for improving the health and well-being of disadvantaged communities, in addition to reducing the disproportionate burden of smoking related illness on the health care system.(11;19) A harm reduction paradigm emphasizes a pragmatic approach to substance use, removing moral judgement, and instead prioritizing health problems associated with substance abuse in order to reduce and minimize individual and societal consequences.(20) Moreover, a harm reduction approach acknowledges that many substance users may never achieve (or even have the desire to achieve) abstinence and that in light of this reality it is important to provide non-abstinence based alternatives to reduce exposure to risk and harm from substance misuse. (20) The success of harm reduction among illicit drug users carries over to tobacco harm reduction efforts, which in addition to a reduction in smoking also includes the use of nicotine replacement therapy (e.g. nicotine patch, gum, inhaler etc.). Among alternative nicotine products, nicotine replacement therapies are the least harmful with a marked reduction in cardiovascular
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disease and negligible carcinogenic risk or risk for acquiring respiratory disease.(21)
Mental illness is strongly associated with the initiation and maintenance of cigarette smoking. (22) Individuals with mental health issues smoke tobacco at an alarmingly high rate, and as a result experience an increased risk for smoking related illnesses. Smokers with mental health issues often start smoking at a younger age, are heavy smokers, and are less likely to participate and succeed in smoking reduction and cessation efforts. In particular, smoking is highly prevalent among individuals with anxiety and/or depression, who are more likely than individuals with other mental health issues to experience failed cessation attempts and relapse post-cessation.(22) Some studies propose a self-medication theory where individuals with mental health issues use substances to cope with their mental illness, while other studies suggest that smoking may act as a catalyst for the development of mental health issues. The opposite is also true as there is evidence that a reduction or cessation of smoking behaviour can improve the physical and mental health related Quality of Life (QOL) of smokers. One study in particular demonstrated a reduction in panic disorder and agoraphobia among quitters;(22) and another demonstrated that smokers were more likely to report poor physical and mental health related QOL when compared to non-smokers and former smokers.(23) Despite well-established benefits of tobacco harm reduction and smoking cessation,(1;24) common misconceptions exist when treating PWUD, for example that smoking cessation will interfere with drug dependence treatment by becoming an additional stressor. Health care providers may bring in their own biases and feel that smoking tobacco is not a priority issue in comparison to other substance use.(17) Yet, research shows that 44-80 % of PWUD are interested in quitting tobacco, 72 % of PWUD reported trying to quit tobacco smoking, and 69 % expressed interest in participating in a group smoking cessation program. Moreover, 82 % of PWUD indicated interest in receiving a prescription for nicotine replacement medication, and among those who considered cessation, approximately 56 % reported being interested in both group intervention and nicotine replacement.(24;25) Therefore, the motivation to quit smoking tobacco exists within the PWUD community - however there is a lack of programs designed to cater to at-risk, drug using, street based individuals. Very few research studies have followed poly-substance users and tracked their smoking activity as well as smoking cessation efforts. Importantly, with the growing crises of opioid use in the US and Canada, novel strategies to deal with the synchronicity of co-addictions are urgently needed.(26-28) Consequently, a community-based participatory action research project was conducted in the inner city population of Ottawa with PWUD.(15) The purpose of the project was to assess the feasibility of implementing a community-based participatory tobacco dependence strategy in Ottawa’s inner city. Feasibility centred outcomes include the impact of the project on the tobacco and poly-substance use of participants, the levels of loss to follow-up in a project that recruits active drug users, and the role of peer researchers in the implementation of the project and in the smoking cessation efforts of participants. Ultimately, the PROMPT project aims to demonstrate that a program focused on tobacco-dependence available in the community with meaningful ‘patient engagement’ of community members representative of the target population is feasible and able to improve quality of life and reduce tobacco use.
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The Participatory Research in Ottawa: Management and Point-of-Care for Tobacco Dependence (PROMPT) project was a feasibility mixed methods prospective cohort study with PWUD using a community-based participatory action model. The study inclusion criteria was: 1) currently living in Ottawa for at least past 3 months prior to enrolment, 2) 16 years or older, 3) have used drugs in the past year (excluding marijuana and alcohol), and 4) had smoked tobacco in the past 7 days. The exclusion criteria included: 1) consent declined (refusal from participant or decision maker); 2) any person accessing addictions treatment (in-patient drug rehabilitation) and hence unavailable for follow up; 3) any person currently or recently (in the past 30 days) enrolled in a smoking cessation program; and 4) anyone with a terminal illness with a life expectancy of less than 3 months. The Ottawa Health Science Network Research Ethics Board approved the study and written informed consent was obtained from all participants. Four individuals with lived experience, members of the PROMPT target population (ex/current tobacco smoker, homeless or at-risk for homelessness, poly-substance user), were selected as community (peer) researchers. The community researchers were selected through a low-threshold, inclusive, and informal interview process. The informal interviews were conducted at the project site with community members. Prospective candidates were assessed for their passion and interest in community wellbeing; prior experience in similar community-based projects was optional. A partnership between community researchers and academics was formed and regular meetings were held throughout the project. All members of the team (including community researchers) participated in the design of the project and questionnaires, including item development, development of strategies for recruitment and retention using a social network approach, data entry, data cleaning, data analysis, preparation of posters/abstracts/handouts, and manuscript preparation and knowledge mobilization. The patient engagement approach used in the PROMPT project, ‘The Ottawa Citizen Engagement and Action Model’ (OCEAM), is described in detail in another publication.(15) The community researchers underwent intensive training prior to participant enrolment. The training focused on privacy, confidentiality, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, harm reduction, the role of peer interviewers, interviewing skills, obtaining study consent from participants, administering surveys with iPads, and administering lung function testing and certification for hand-held spirometry and oscillometry. After the training, community researchers created a list of project requirements that they posted in participant interview rooms as an added measure to adhere to the project’s protocol and procedures. Community researchers were given an honorarium ($15/hour) for the time spent conducting project related activities such as trainings, meetings, consenting, follow-ups, social networking for recruitment and retention, knowledge mobilization, and data cleaning and analysis. Throughout the life of the project, community researchers also navigated their social networks to encourage participants to attend life-skills workshops, nurse counselling, and monthly follow-up appointments.
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The structure of the recruitment strategy, interviewing and point-of-care testing, closely followed the principles of community-based participatory action research. As pairs, community researchers conducted street-based recruitment five days a week assessing eligibility and providing appointment times for enrolment, either on the same day or as per the potential participants’ convenience. Coercion for participation was avoided by pairing of community researchers and through rigorous ethics training. At the baseline visit community researchers acquired consent, administered iPad based baseline questionnaires, two point-of-care lung function tests, and hand-held spirometry and oscillometry. The consent process was conducted at the community research office. Community researchers also administered a monthly iPad based follow-up survey for six months ending with the administration of hand-held spirometry and oscillometry at the last follow-up. Participants were given $20 at baseline enrolment and $25 at each monthly visit to compensate for their time and effort. All participants were enrolled in the Smoking Treatment for Ontario Patients (STOP) program led by the Centre for Addiction and Mental Health (CAMH), Toronto Branch, in order to receive free and ‘off-label’ Nicotine Replacement Therapy (NRT). After providing consent to participate in the PROMPT project participants met with an expert tobacco dependence treatment nurse from the Ottawa chapter of the Canadian Mental Health Association (CMHA). The CMHA nurse was specifically hired for the PROMPT project and was available onsite twice a week to offer one-on-one counselling and individualized NRT available through the STOP program. The participants could meet the nurse as frequently as requested by the participant or as deemed clinically necessary by the nurse. The study followed the current clinical practice of the Canadian Mental Health Association to prescribe and dispense an amount of NRT titrated to suppress nicotine cravings. This could be refereed as "off-label" use of NRT, because the standard prescription of NRT, especially of nicotine patches, is titrated according to the number of daily cigarettes used. The CMHA nurse provided brief counselling sessions (approximately 20 minutes) using motivational interviewing techniques and strategies to help participants strengthen their motivation to change and reduce their dependence on nicotine. The nurse and academic staff also supported participants in their efforts to access housing, health care services, and legal support by writing letters of support and connecting participants to community resources. Lastly, exhaled CO was measured during visits with the nurse using a Bedfont Micro Smokerlyzer for biochemical confirmation of self-reported quitting. To further involve the community, weekly peer-led life skills workshops were conducted on a variety of topics such as financial literacy, banking, peer-support, HIV/Hepatitis C education, pet-care, cooking, mindfulness meditation and art. Community researchers took the lead in organizing and conducting these workshops. Volunteers from community organizations helped facilitate some of the life-skills workshops. In addition, quarterly Community Knowledge Forums were designed and conducted by community researchers and project participants. The knowledge mobilization forums helped disseminate project outcomes and were attended by PROMPT participants, community members, healthcare service provider allies, and occasionally by the local media, the Ottawa Police, and members of the provincial parliament.(29). PROMPT project related activities were conducted at a Community Research Centre, near Ottawa’s largest homeless shelter, located downtown in Ottawa’s popular ByWard market which
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is at the centre of open drug consumption and homelessness. A Community Advisory Committee (CAC) was formed at the centre with five voting members (PROMPT community researchers and participants) and five non-voting members from neighbourhood community healthcare agencies with balanced sex, gender, race, language and indigenous representation. Community researchers reached out to the community to interview and select CAC members. The CAC meets monthly and the members named the Centre appropriately as the Bridge Engagement Centre (the Bridge), a place to bridge gaps between different communities.
Data and Measures
The participants underwent an expired carbon monoxide (CO) test, spirometry, and an oscillometry test at baseline and at the end of the project, 6 months after enrolment. Seven questionnaires were administered by the community researchers to all participants at baseline: 1) demographic information: detailed tobacco smoking history, drug use questionnaire and a social network questionnaire, 2) Fagerstorm Test for Nicotine Dependence (FTND),(30) 3) the BOLD core questionnaire used in the CanCOLD study which aims to evaluate respiratory symptoms (cough, phlegm, whistling/wheezing, shortness of breath),(31;32) 4) Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT): an open-access disease-specific questionnaire,(33) 5) EQ-5D-3L: a well-validated five item questionnaire which measures generic quality of life,(34) 6) Patient Health Questionnaire (PHQ-8): an eight-item open-access questionnaire which is used to establish provisional depressive disorder diagnoses as well as grade depressive symptom severity,(35) and 7) the Generalized Anxiety Disorder (GAD) questionnaire, a 7-item questionnaire to assess generalized anxiety disorder.(15–21) A brief follow-up questionnaire was administered by the community researchers at monthly follow-ups, pertaining to questions regarding current tobacco smoking status and the barriers and facilitators of smoking. The community researchers administered a questionnaire at 6 months to inquire about participants overall experience with the project as well as the changes and challenges in tobacco smoking and poly-substance use experienced over the course of the project. All project related materials, including the consent form were in English. PHQ-8: Substance use disorders and depression often occur simultaneously within the same individual.(36) To assess the prevalence and impact for this cohort, an eight-item version of the Patient Health Questionnaire (PHQ-8) was used. The PHQ-8 consists of eight items on which the DSM-IV diagnosis of depressive disorders is based. Each participant answers the 8 questions with four responses (not at all to nearly every day (0 to 3)) assigned to each category. The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0-4 represents no significant depressive symptoms; 5-9 mild depressive symptoms; 10-14 moderate; 15-19 moderately severe; and 20-24 severe.(37) GAD-7: The Generalized Anxiety Disorder 7-Item (GAD-7) questionnaire is a self-administered one-dimensional scale to assess the presence of the symptoms of generalized anxiety disorder (GAD) referred to in the DSM-IV. The score for each of the 7 items ranges from 0 (not at all) to 3 (nearly every day) with a possible total score of 0 to 21. The total score may be categorized into four severity groups: minimal/no anxiety (0–4), 2) mild (5–9), 3) moderate (10–14), or severe (15–21) with an optimum cut-off value for GAD at 10 points.(38)
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EQ-5D-3L: A frequently applied general health status measure is the EuroQol questionnaire (EQ-5D-3L). The EQ-5D-3L was a brief questionnaire used to evaluate the health related quality of life of the PROMPT cohort.(39) The questionnaire consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression which provides a single index value for health status for each individual.(40) The participants were also given a visual analogue scale (EQ-VAS) and asked to rate their health on a 20 cm vertical scale that ranges from 0-100 with 0 representing ‘the worst health you can imagine’ and 100 representing ‘the best health you can imagine’.(40)
Data Analyses
The difficulty accessing the target population, the precarious nature of the target population’s living situation, and budget constraints determined the sample size. Potential confounders were included in the development of the study exclusion criteria. A retention rate of 40% with full data collection at the 6-month follow-up was considered adequate for the project to be considered feasible, a priori. As a result of the day-to-day challenges faced by the target population (e.g. housing instability, high incarceration rate, food insecurity, intermittent telephone access etc.) the study investigators estimated a high loss to follow-up, and decided a retention rate of at least 40% was reasonable and in line with the literature on high drop-out rates for smoking cessation projects and projects with low-income communities.(41;42) Other feasibility centered outcomes were based on monthly follow-up data, such as self-reported and biochemically validated tobacco use; the proportion of participants that participated in each follow-up; and the role of peer researchers on project implementation and impact. In particular, the variables used to measure both the primary and secondary outcome include cigarette use per day and exhaled CO as measured by a Bedfont Micro Smokerlyzer, respectively. The monthly follow-up questionnaire included open-ended questions, in order to get as much qualitative feedback as possible from participants. A thematic analysis was conducted in order to identify recurring patterns (i.e. themes) in the data. The themes were determined not only by quantity but also quality in relation to study outcomes. Saturation was achieved when variation decreased, and no new themes emerged from the data.
Statistical analyses were performed using SAS version 9.3. Descriptive statistics were computed to provide an understanding of population characteristics and distribution of the main study variables. Paired t-tests (with Bonferroni correction) were conducted to compare baseline data and monthly follow-up data (six months) on tobacco smoking per day. Baseline illicit substance use was not available because the initial survey asked for drug use ever and not current use. Follow-up data collection captured current illicit substance use. We employed an Intention-To-Treat (ITT) analysis a priori, as we were expecting losses to follow-up.
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Between March and August 2016, the community researchers recruited, consented and completed baseline assessments on 80 participants. The baseline characteristics of the study’s participants are presented in Table 1. Most participants were male (70%), Caucasian (77.5%), and between the ages of 41 and 50. Many of the participants (31.3%) completed their high school education, some of the participants started higher education (26.3%), and a few (5.0%) completed college or university. A large proportion of participants had an average monthly income between $1000-$1999, with many reporting some level of food insecurity as measured by the frequency in which participants experienced hunger and were unable to afford food. Lastly, the majority of participants reported English as their first language. There was no significant difference in baseline demographic data between participants who were followed to project end (n=34) relative to participants lost to follow-up.
Table 1: Demographic characteristics (n=80)
Participant Characteristics Baseline %
(N=80)
Study End %
(N=34)
Loss to Follow-Up %
(N=46)
Gender
Male Female
70.0 30.0
59 41
78 22
Age
16-30 31-40 41-50 51-65 N/A
14.8 8.7 44.4 30.9 1.2
12 6 41 41 0
17 11 48 24 0
Ethnicity:
Caucasian: First Nations: Inuit: Métis**: East Asian: Other:
77.5 16.3 1.2 1.2 1.3 2.5
71 20 0 3 3 3
83 15 2 0 0 2
Education
Grade School/Some High School High School Graduate/GED Some College or University College/University Completed None N/A
33.7 31.3 26.3 5.0 1.2 2.5
35 32 24 6 3 0
33 31 29 4 2 1
Monthly Income
<$499 $500-$999 $1000-$1999 $2000-$2999 N/A
11.3 33.7 43.8 10.0 1.2
6 29 56 9 0
15 37 35 11 2
Food Insecurity
Always Most of the time Occasionally Sometimes Usually Never N/A*
15.0 11.2 16.3 26.2 10.0 18.8 2.5
18 6 12 26 9 29 0
13 15 20 26 11 11 4
*N/A=missing or refuse to answer; ** Métis - are a group of peoples in Canada who trace their descent to First Nations peoples and European settlers. They represent the majority of those identifying as Métis, though smaller communities also exist in the United States. They are recognized as one of Canada's aboriginal or indigenous peoples under the Constitution Act of 1982, along with First Nations and Inuit peoples.
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In Table 2, baseline information regarding self-reported health conditions, smoking and drug use related data for project participants is provided. Most of the participants at baseline smoked between 15-25 cigarettes daily for a period of 21-30 years, and purchased company branded cigarettes from convenience stores. However, over half of the participants also bought contraband cigarettes from a local dealer. The majority of participants reported using crack and marijuana in their lifetime. Table 2. Baseline tobacco smoking, self-reported health conditions and poly-substance use (N-80)
Participant Characteristics Baseline % (N=80) Study End % (N=34) Loss to Follow-Up %
Supplementary Table 1 demonstrates the frequency of depressive symptoms as measured by the PHQ-8, generalized anxiety symptoms as measured by GAD-7, and the generic quality of life as measured by the EQ-5D-3L visual analogue scale. Mild anxiety was estimated to be present in 30% of participants and 32.6% of participants had moderate to severe anxiety scores. Mild depressive symptoms were present in 20% of participants and moderate to severe depression symptoms were present in 15% of participants. Mean EQ-5D-3L Visual Analog Scale was 62.2, with a standard deviation of 17. Supplementary Table 2 shows that the majority of participants accessed at least two types of nicotine replacement therapy (NRT) of the four types of NRT available in the project: the gum, lozenge, inhaler, and patch. While it is expected that participants that followed to study end accessed the most NRT and visited the nurse most often - the costs associated with NRT accessed and visits to the nurse are not substantially greater than the costs incurred by participants lost to follow-up. Supplementary Table 3 provides changes in self-reported tobacco smoking and poly-substance use over the study’s six-month follow-up period. Participants smoked an average of 20.5 cigarettes at baseline in comparison to 9.3 cigarettes at the 6-month follow-up. A paired t-test comparing tobacco use per day at baseline with monthly follow-ups revealed an average reduction of 11.2 cigarettes (p=0.0001) from baseline to study end. Participants also reported reductions in illicit substance use (18.8%.) between baseline and study-end, including a reduction in the opioids heroin (6.3%), fentanyl (2.6%), and oxycontin (3.8%). Drug use data reporting was not uniform, for example some participants reported the use of crack in dollar figures whereas others reported in grams. Community researchers helped translate the dollar figures into grams in order to harmonize data for data analysis.
Figure 1 demonstrates the frequency of participants following up at monthly follow-up visits. Community researchers mobilized their social networks to encourage attendance at follow-up visits. Feedback from participants and community researchers indicated two main reasons for loss to follow up: lack of transportation or food during follow-ups, and loss of participants to incarceration as the target community is subject to higher rates of enforcement for petty crimes and low level drug trafficking and are often targeted by "drug sweeps" before key tourism seasons.
Figures 2 and 3 demonstrate self-reported data from 34 participants at six months regarding changes in smoking and poly-substance use. The tobacco smoking quit rate was defined as biochemically-validated 7-day point prevalence smoking abstinence prevalence at the 6-month follow-up visit. Reduced use for cigarettes smoking and other drug use was defined as self-reported reduction from project enrolment to the last follow-up visit. Data about tobacco use and illicit drug use was collected at monthly follow-up visits and at the final 6-month post project survey. At around the 2nd follow-up, the community researchers were a bit overwhelmed with the number of participants at monthly follow-up visits. The project coordinator (TK) tried to help by administering a few monthly follow-up surveys. However, the community researchers quickly observed that when the project coordinator (TK) conducted the monthly follow-up interview, the self-reported drug use was less than when they conducted the interviews. A decision was made that only community researchers would conduct the monthly follow-up interviews. Out of the
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total recruited participants (n=80), 32.5% (p=0.0001) reported reducing their tobacco use while 18.8% reported reducing their poly-substance use, since the beginning of the program with ITT. Supplementary Figure 1 provides the frequency of participants who reported having problems within each dimension of EQ-5D-3L. Approximately 24.4% of the participants reported problems with mobility, 6.3% with self-care, 15.2% with usual activities, 62.0% with pain, and 55.7% with anxiety. The average EQ-VAS score was 62.2 with a range of 3-100.(36) Supplementary Figure 2 shows the reduction of cigarette use, paralleled by a reduction in exhaled CO levels measured at each participant follow-up over the full study period (11.2 cigarettes, p=0.0001). Exhaled CO monitoring served as biochemical feedback for participants and as objective data on smoking cessation for the project.
Qualitative Results Several themes materialized from a thematic analysis of the qualitative data collected during the project’s six-month follow-up period. The first theme that emerged was regarding the role of peer researchers and their impact on participant outcome. Many of the participants believed their progress was due to the support they received from the project’s peer researchers. The leadership and coordination of peer researchers at monthly follow-ups, outreach, and project related workshops helped create a sense of community and connection that many participants report helped them manage their concurrent addictions. When asked what helped them reduce or quit, many of the participants mentioned the study’s community researchers:
“Felt well supported by Kelly and Tiffany” (Participant 1)
“Outreach by Kelly and Tiffany” (Participant 2)
Moreover, the impact of using a community based approach and peer-to-peer model was touched upon in the data, such as the following quote by a PROMPT participant:
“I really feel like I belong somewhere, I do not like to call it a program, it is a group.
Program feels like something forced upon you, this is so welcoming, I feel like coming
here and I get help.” (Participant 3)
Another theme that was present in the data captured the health benefits of smoking cessation. The following quotes speak to the changes in quality of life experienced by PROMPT participants, after reducing or quitting tobacco and other substances:
“Now that I am smoking less, I did not have to sneak out on my grandkids when I went to
play with them over the weekend. Else, I always had to make up a story and sneak out
hurriedly to take a few puffs, because the cravings were so bad. I had no cravings this
weekend and played for the full four hours with my grandkids, felt so good.”
(Participant 4)
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“My chronic back pain is so much better now that I am smoking only 2-3 cigarettes.” (Participant 5)
During the end of the study many of the participants started to associate smoking with other substance use:
“I didn’t realize that smoking had such a large effect on my breathing and general
health. Now that I think about it everyone who smokes crack or uses [other illicit
substances such as heroin, fentanyl, cocaine etc.] also smokes cigarettes.” (Participant 6) Finally, many of the participants reported that free access to “off-label” personalized Nicotine Replacement Therapy helped them in their efforts to reduce or quit smoking tobacco:
“The NRT was helpful, especially being able to choose whatever mix I needed to help me
kick the habit” (Participant 7)
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Discussion & Conclusion The PROMPT project was a feasibility mixed methods prospective cohort study that describes the detailed psycho-socio-economic variables associated with tobacco smoking and poly-substance use in the most at-risk marginalized inner city population of Ottawa (Canada). The project demonstrated that a comprehensive program focussed on tobacco dependence management available in community and implemented in true partnership with community (peer) researchers is feasible (greater than 40% retention rate) and may even produce outcomes beyond tobacco smoking reduction or cessation. In the PROMPT cohort, participants at baseline smoked an average of 20.5 cigarettes per day. However, with time mean cigarette use reduced significantly (9.3, p=0.0001) in the majority of the participants (see figure 2). Smoking reduction is known to lead to smoking cessation,(43) and thus a longer duration of support may well have produced a higher percentage of smoking cessation in the study cohort. Cessation was defined as smokers with exhaled carbon monoxide ≤ 10 ppm (see figure 2). Moreover, a sizeable number of participants at study-end self-reported a reduction and in some cases cessation of other poly-substance use (18.8%) (see figure 3). Within opioid use a self-reported reduction was observed in heroin (6.3%), fentanyl (2.6%) and OxyContin (3.8%). Participants that followed up the longest were more likely to report a reduction in cigarette smoking and illicit substance use, in addition to an improvement in overall socioeconomic status, relative to participants that were lost to follow-up early in the project. Qualitative findings show that PROMPT participants experienced considerable psycho-socio-economic benefits such as better health (weight gain, improved breathing and physical exercise, enrolments in school and drug treatment etc.) and social outcomes (e.g. returning to the work force, improved housing, reunification with family, greater community engagement etc.). Overall qualitative findings reveal that the quality of life of a third of the participants improved significantly; and that community based research involving peer-to-peer engagement holds the potential for improving health and meaningfully engaging marginalized communities in health research. It is important to note, however, that while observational research has been documented to be consistent with randomized control trials in estimating the magnitude of the effects of treatment (44;45) – the outcomes of the PROMPT project will be further investigated in a pragmatic multi-centre RCT with homeless (at-risk for homelessness) People Who Use Drugs in Canada and the US. It is well known that socioeconomic status in a society influences one’s health and wellbeing. Groups that have been traditionally disadvantaged, such as inner city populations tend to have high rates of tobacco smoking.(8) Furthermore, smoking rates have been declining in Canada, the US and among other high-income countries; however the decline has been slower or nonexistent among low SES groups. Health interventions such as PROMPT tackle social determinants of health that facilitate substance use and poor health. The wide-ranging benefits (e.g. return to work, improved social capital, seeking out health care etc.) of holistic interventions can contribute considerably to the reduction of disparities in morbidity and mortality in marginalized communities with an estimated economic value of $1.02 trillion.(46) This is especially important as the findings of the study show that the majority of participants are relatively young (see table 1) and have been smoking for at least 10 years (see table 2), qualifying the majority of PROMPT participants as high risk for chronic disease burden and many years of productive life lost.
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In clinical settings, tobacco use is strongly associated with poly-substance use.(13) The neurobiology of addiction demonstrates that tobacco may have the strongest physiological pull and thus may be the most difficult to quit. Addiction research speaks to the entangled nature of tobacco and poly-substance use strengthened by shared neurobiological processes that trigger dopamine release in the reward pathway of the brain creating pleasure and an additive effect that enhances enjoyment and dependence.(47) Adolescent research and animal studies confirm the ‘gateway to illicit drugs’ hypothesis that suggests the introduction of tobacco at an early age increases the likelihood of future illicit drug use.(48-50) Moreover, epidemiological research on addiction reveals better treatment and recovery outcomes for poly-substance users that quit tobacco use in comparison to counterparts that continue to smoke tobacco.(51-53) The potential for tobacco use reduction and quitting to lead to the reduction and quitting of other poly-substance use (as seen in PROMPT participants) is thus neuro-biologically plausible.(1) Studies in various clinical populations have reported high rates of tobacco use among persons with depression and anxiety.(54) According to research, current smokers were 2.5 times more likely to have an anxiety disorder; however, if they were former smokers there is no significant difference in the odds of having an anxiety disorder.(54) As noted in the PROMPT cohort, 30.0% reported mild anxiety, 18.8% reported moderate anxiety, and 13.8% reported severe anxiety (see supplementary table 3). According to Statistics Canada, the lifetime prevalence of GAD in the general population is approximately 5% in Canada.(55) Furthermore, the high comorbidity of anxiety and depressive disorders and the high correlation between depressive and anxiety measures is well known. Not surprisingly, our depression measure, the PHQ-8, strongly correlated with the GAD-7 and therefore in the PROMPT cohort we observed that 37.5% had mild depressive symptoms, 20.0% had moderate depressive symptoms, and 12.5 and 1.25% had moderately severe and severe depressive symptoms, respectively (see supplementary table 3).(35) There is no dearth of literature that documents that both neurobiological and psychosocial factors reinforce the use of nicotine in people with psychiatric illnesses.(56;57) For individuals with chronic mental illness, smoking is a major part of their daily routine and is an activity that provides some structure and a sense of routine to a day with few activities.(56;57)
The PROMPT project utilized a community-based participatory action approach with meaningful ‘patient engagement’ with community (peer) researchers that were truly representative of the study’s target population. The PROMPT community (peer) researchers were seen as confidants and were able to encourage participants by providing examples of their own struggles and the successes they experienced in their personal journeys to recovery. With complex social determinants of health at play in the PROMPT population, the project’s community-based participatory approach allowed PROMPT participants to develop social networks and enhance their knowledge of available community resources and supports. Furthermore, the participants found that the various community capacity building events and activities led by their peers encouraged their continued engagement and provided them additional support, if and when they needed it. According to Davidson et al, peer support staffs are viewed more like friends than non-peer case managers or clinical staff for several reasons, a major one being that they share personal stories with the participants which allows for the development of social relationships. Furthermore, the relationships community (peer) researchers developed with participants was reciprocated as both parties learned from each other and provide support to one another.(58)
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Future research and additional programming is required to understand the mechanisms by which interventions such as PROMPT help marginalized hard-to-reach inner city populations. A community-based participatory action research approach, “by the people, for the people”, is promising as it provides a novel approach to complex public health issues such as poverty and isolation leading to homelessness, tobacco smoking and poly-substance use. The PROMPT project’s patient centered, personalized, tailored approach to dispensing NRT and developing a quit plan and supports appropriate for active drug users is difficult to replicate in a clinical setting and necessitates a community based approach. The project’s success recruiting, engaging, and improving the health outcomes of a highly vulnerable hard-to-reach population surpassed initial expectations of feasibility and tobacco reduction and cessation. The impact of the project speaks to the need for additional, personalized, and holistic community based peer-led support to reduce health inequities in marginalized communities.(59) The PROMPT model’s holistic and compassionate approach can be also be used as part of the strategy dealing with the growing opioid crises in the US and Canada.(60) Additionally, the model holds the potential to be adapted for other complex and chronic health issues such as diabetes and obesity in different populations and in different settings including community-based integrated care.
Study Limitations & Delimitations A limitation of the project was that it was conducted in one inner city setting. Nonetheless, many of the inner city populations across the US and Canada have a demographic profile similar to the participant profile in the PROMPT project. Thus, the project can be implemented in similar settings across the US and Canada. Additionally, a larger study with a greater sample size will need to be conducted to demonstrate an effect on clinical outcomes. Lastly, while the findings are promising, the lack of a control limits the inferences that can be made from the study results. The PROMPT study was a mixed method feasibility study designed to lay the foundation for a Randomized Clinical Trial (RCT). A plan is underway to conduct a pragmatic multi-centre randomized control trial (RCT) to examine the impact and potential of the PROMPT model.
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Acknowledgments and Disclosures We are indebted to all of our PROMPT community researchers, without their trust in the academic research team and dedication towards harm reduction this project would not have been possible. PROMPT participants demonstrated resilience throughout the project; and despite their day-to-day struggles they kept coming for follow-ups, we are so very grateful for your inner strength. We thank Dr. Peter Selby and his team at the CAMH in Toronto, Canada for their belief in the PROMPT model and support through the STOP program. We are also thankful to the Ottawa chapter of CMHA for providing excellent nurses for our project. To our local healthcare allies: the Shepherds of Good Hope, Ottawa Inner City Health Inc., Sandy Hill Community Health Centre (CHC), Somerset West CHC, we could not have implemented the project without your in-kind support. Our Community Advisory Committee at the Bridge, comprised of K. McNaughton (Ottawa Inner City Health Inc.), R. Boyd (Oasis, Sandy Hill CHC), S. Willmott (Somerset CHC), J. Haddad (CMHA), S. Pakhale (PROMPT lead scientist), Tara, Rick, Ted and Petrina (PROMPT participants) and K. Florence (a PROMPT community researcher), meets monthly at the Bridge and guides the mission and vision of the space along with overseeing the smooth functioning of all projects. We are indebted to the vision, dedication and passion of the Bridge CAC. We are thankful to the Ottawa Hospital, especially Dr. Jack Kitts, Dr. Jim Worthington, Dr. Jeff Turnbull, Dr. Mike Tierney, Dr. Bill Cameron, Dr. Ian Graham, Dr. Antoine Hakim and the administrative staff for administrative and moral support in maintaining our community space, the Bridge Engagement Centre. We thank the EuroQol questionnaire team (EQ-5D-3L) for allowing us to use the questionnaire pro-bono for this project. Last but certainly not least we are very grateful to all the reviewers of this manuscript, your feedback has been immensely helpful.
No competing interests
Funding: This work was supported by the Champlain Local Health Integration Network; Department of Medicine and the Divisions of Respirology and Cardiology at the Ottawa Hospital, Ottawa, Canada. "All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work." All available data can be obtained by contacting the corresponding author.
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Table Legends Table 1: Demographic characteristics (n=80) Table 2: Baseline tobacco smoking, self-reported health conditions and poly-substance use Supplementary Table 1: Results from the baseline GAD-7, PHQ-8 and EQ-5D-3L questionnaires Supplementary Table 2: Access to Nicotine Replacement Therapy, Canadian Mental Health Association Nurse, and Associated Costs Supplementary Table 3: Mean cigarettes per day (CPD) and poly-substance use data at monthly follow-ups collected at the same time point (Intention-To-Treat Analysis)
Figure Legends
Figure 1: Frequency of participants following up monthly up to six months Figure 2: Poly-substance use and tobacco smoking at the 6 month follow-up visit Figure 3: Poly-substance use trend over six months Supplementary Figure 1: Frequency of participants reporting each dimension of the EQ-5D-3L at the baseline Supplementary Figure 2: Mean cigarettes per day and exhaled CO per month of six month study duration.
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(36) Swendsen JD, Merikangas KR. The comorbidity of depression and substance use disorders. Clinical psychology review 2000;20(2):173-89.
(37) Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. Journal of affective disorders 2009;114(1):163-73.
(38) Ruiz MA, Zamorano E, Garc+¡a-Campayo J, Pardo A, Freire O, Rejas J. Validity of the GAD-7 scale as an outcome measure of disability in patients with generalized anxiety disorders in primary care. Journal of affective disorders 2011;128(3):277-86.
(39) van der Zanden BP, Dijkgraaf MG, Blanken P, de Borgie CA, van Ree JM, van den Brink W. Validity of the EQ-5D as a generic health outcome instrument in a heroin-dependent population. Drug and alcohol dependence 2006;82(2):111-8.
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(40) Tran BX, Ohinmaa A, Nguyen LT. Quality of life profile and psychometric properties of the EQ-5D-5L in HIV/AIDS patients. Health and Quality of life outcomes 2012;10(1):1.
(41) Belita E, Sidani S. Attrition in Smoking Cessation Intervention Studies: A Systematic Review. CJNR (Canadian Journal of Nursing Research) 2015;47(4):21-40.
(42) Courtney RJ, Clare P, Boland V, Martire KA, Bonevski B, Hall W, et al. Predictors of retention in a randomised trial of smoking cessation in low-socioeconomic status Australian smokers. Addictive Behaviors 2017;64:13-20.
smoking cessation: results from a double blind, randomized, placeboΓÇÉcontrolled trial of
nicotine gum with 2ΓÇÉyear followΓÇÉup. Addiction 2003;98(10):1395-402.
(44) Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. New England Journal of Medicine 2000;342(25):1887-92.
(45) Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. New England Journal of Medicine 2000;342(25):1878-86.
(46) Thornton RL, Glover CM, Cené CW, Glik DC, Henderson JA, Williams DR. Evaluating strategies for reducing health disparities by addressing the social determinants of health. Health Affairs. 2016 Aug 1;35(8):1416-23. Health Affairs 2016 2016Available from: URL: http://content.healthaffairs.org/content/35/8/1416.short
(47) Mendelsohn C, Wodak AM A. Smoking cessation in people with alcohol and other drug problems. Australian Family Physician 2016 Aug 1;45:569-73.
(48) Reed SC, Izenwasser S. Nicotine produces long-term increases in cocaine reinforcement in adolescent but not adult rats. Brain Research.
(49) McQuown S, Dao J, Belluzzi J, Leslie F. Differential behavioral and neurochemical effects of nicotine treatment in adolescent and adult rats. The FASEB Journal 2008;22(1_MeetingAbstracts):905-3.
(50) Corrigall WA. Nicotine self-administration in animals as a dependence model. Nicotine Tob Res 1999 Mar 1;1(1):11-20.
(51) Weinberger AH, Funk AP, Goodwin RD. A review of epidemiologic research on smoking behavior among persons with alcohol and illicit substance use disorders. Preventive Medicine.
(52) Lemon SC, Friedmann PD, Stein MD. The impact of smoking cessation on drug abuse treatment outcome. Addictive Behaviors 2003 Sep;28(7):1323-31.
(53) Kohn CS, Tsoh JY, Weisner CM. Changes in smoking status among substance abusers: baseline characteristics and abstinence from alcohol and drugs at 12-month follow-up. Drug Alcohol Depend 2003 Jan 24;69(1):61-71.
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(54) Degenhardt L, Hall W. The relationship between tobacco use, substance-use disorders and mental health: results from the National Survey of Mental Health and Well-being. Nicotine & Tobacco Research 2001;3(3):225-34.
(57) el-Guebaly N, Cathcart J, Currie S, Brown D, Gloster S. Smoking cessation approaches for persons with mental illness or addictive disorders. Psychiatric Services 2002.
(58) Rowe M, Bellamy C, Baranoski M, Wieland M, O'Connell MJ, Benedict P, et al. A peer-support, group intervention to reduce substance use and criminality among persons with severe mental illness. Psychiatric Services 2007.
(59) Wilson SR, Strub P, Buist AS, Knowles SB, Lavori PW, Lapidus J, et al. Shared treatment decision making improves adherence and outcomes in poorly controlled asthma. Am J Respir Crit Care Med 2010;181(6):566-77.
(60) Clarke H, Katz J. No quick fix to society's opioid crisis. Toronto Star 2016Available from: URL: https://www.thestar.com/opinion/commentary/2016/09/26/no-quick-fix-to-societys-opioid-crisis.html
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Participants 13* (a) Report numbers of individuals at each stage of study—eg numbers potentially eligible, examined for eligibility,
confirmed eligible, included in the study, completing follow-up, and analysed 13
(b) Give reasons for non-participation at each stage 13
(c) Consider use of a flow diagram 13
Descriptive data 14* (a) Give characteristics of study participants (eg demographic, clinical, social) and information on exposures and
potential confounders 6
(b) Indicate number of participants with missing data for each variable of interest 10-11
(c) Cohort study—Summarise follow-up time (e.g., average and total amount) 7-9
Outcome data 15* Cohort study—Report numbers of outcome events or summary measures over time 10-15
Case-control study—Report numbers in each exposure category, or summary measures of exposure N/A
Cross-sectional study—Report numbers of outcome events or summary measures N/A
Main results 16 (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95%
confidence interval). Make clear which confounders were adjusted for and why they were included N/A
(b) Report category boundaries when continuous variables were categorized N/A
(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period N/A
Other analyses 17 Report other analyses done—eg analyses of subgroups and interactions, and sensitivity analyses N/A
Discussion
Key results 18 Summarise key results with reference to study objectives 17-19
Limitations 19 Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction
and magnitude of any potential bias 19
Interpretation 20 Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results
from similar studies, and other relevant evidence 17-19
Generalisability 21 Discuss the generalisability (external validity) of the study results 17-19
Other information
Funding 22 Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on
which the present article is based 20
*Give information separately for cases and controls in case-control studies and, if applicable, for exposed and unexposed groups in cohort and cross-sectional studies.
Note: An Explanation and Elaboration article discusses each checklist item and gives methodological background and published examples of transparent reporting. The STROBE
checklist is best used in conjunction with this article (freely available on the Web sites of PLoS Medicine at http://www.plosmedicine.org/, Annals of Internal Medicine at
http://www.annals.org/, and Epidemiology at http://www.epidem.com/). Information on the STROBE Initiative is available at www.strobe-statement.org.
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Management and Point-of-Care for Tobacco Dependence (PROMPT): a feasibility mixed methods Community Based
Participatory Action Research project in Ottawa, Canada
Journal: BMJ Open
Manuscript ID bmjopen-2017-018416.R3
Article Type: Research
Date Submitted by the Author: 21-Nov-2017
Complete List of Authors: Pakhale, Smita; Ottawa Hospital; Ottawa Hospital Research Institute Kaur, Tina; Ottawa Hospital Research Institute Charron, Catherine; Department of Medicine in Ottawa; Ottawa Hospital
Florence, Kelly; The Bridge Engagement Centre Rose, Tiffany; The Bridge Engagement Centre Jama, Sadia; Ottawa Hospital Research Institute Boyd, Rob; Sandy Hill Community Health Centre Haddad, Joanne; Canadian Mental Health Association Ottawa Branch Alvarez, Gonzalo ; Ottawa Hospital; Ottawa Hospital Research Institute Tyndall, Mark; British Columbia Centre for Disease Control; University of British Columbia
<b>Primary Subject Heading</b>:
Addiction
Secondary Subject Heading: Public health, Smoking and tobacco, Health policy
Keywords:
Health policy < HEALTH SERVICES ADMINISTRATION & MANAGEMENT,
Public health < INFECTIOUS DISEASES, EPIDEMIOLOGY, SOCIAL MEDICINE
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Management and Point-of-Care for Tobacco Dependence (PROMPT): a feasibility mixed
methods Community Based Participatory Action Research project in Ottawa, Canada
Dr. Smita Pakhale, MD, MSc1,2,3*, Tina Kaur, MPH2, Dr. Catherine Charron, MD1,3, Kelly Florence4, Tiffany Rose4, Sadia Jama, MSc2, Robert Boyd, BA5, Joanne Haddad, RN6, Dr. Gonzalo Alvarez, MD, MSc1,2,3, Dr. Mark Tyndall, MD, PhD7,8 1The Ottawa Hospital, Ottawa, Canada 2The Ottawa Hospital Research Institute (OHRI), Ottawa, Canada 3University of Ottawa, Ottawa, Canada 4Community (Peer) Researcher, the Bridge Engagement Centre, Ottawa, Canada 5Oasis, Sandy Hill Community Health Centre, Ottawa, Canada 6Canadian Mental Health Association, the Ottawa Branch, Canada 7British Columbia Centre for Disease Control, Vancouver, Canada 8University of British Columbia, Vancouver, Canada *Corresponding Author: Dr. Smita Pakhalé, MD, FRCPC, MSc (Epidemiology & Biostatistics) Associate Scientist - Ottawa Hospital Research Institute Assistant Professor - University of Ottawa Staff Respirologist - Division of Respiratory Medicine The Ottawa Hospital 501 Smyth Road Ottawa, Ontario, K1H 8L6, Canada Phone: 613-737-8899 Ex. 79428 Email: [email protected] http://www.ohri.ca/Profiles/pakhale.asp SP, KF, MT contributed to the conception and design of the study. SP, TK, KF, TR, CC, SJ, RB and JH made substantial contributions to the acquisition of the data, data entry, or data analysis and data interpretation. SP, TK, CC, KF, TR, SJ, RB, JH, GA and MT were all involved in the drafting of the manuscript or the revisions made to the manuscript. All authors have given final approval of the version of the manuscript submitted for publication, and agree to be accountable for all aspects of the work. Key Words: Tobacco dependence, patient engagement, opioid crises, community-based participatory action research, peer-led, drug use, substance use disorder Word Count: 9091
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Abstract Objective: To determine the feasibility of a Community-Based Participatory Tobacco-Dependence Strategy (PROMPT) in the inner city population of Ottawa (Canada). Design: A feasibility mixed methods prospective cohort study following principles of Community Base Participatory Action Research. Intervention: Recruited 80 people who use drugs, followed them for six months while providing access to counselling, nicotine replacement therapy and peer-support in a community setting. Setting: Community research office in downtown Ottawa, adjacent to low-income housing, shelter services, and street based drug consumption.
Primary Outcome: retention rate at 6-month follow up; Secondary Outcome: biochemically-validated 7-day point prevalence smoking abstinence at 26 weeks, self-reported abstinence in the past 7 days with exhaled carbon monoxide ≤ 10 ppm. Results: The average age of participants’ was 43.8 years. The 6 month follow-up rate was 42.5%. The mean number of smoking years reported was 27.3 years. The participants were 70% male, 33.7% reported less than a high-school education, 21% identified as indigenous, and 43.8% reported an income between $1000-1999/month. The baseline mean daily cigarette use was 20.5 cigarettes and 9.3 cigarettes at study end, with mean reduction of 11.2 cigarettes at six months (p=0.0001). There was a considerable reduction in self-reported illicit substance use (18.8%), including a reduction in the opioids heroin (6.3%), fentanyl (2.6%), and oxycontin (3.8%). The study findings also reveal psycho-socio-economic benefits such as improved health, return to work, and greater community engagement. Conclusions: The PROMPT project describes socio-economic variables associated with tobacco and poly-substance use. A program focused on tobacco dependence, easily accessible in the community, and led by community peers with lived experience is feasible to implement and has the potential to support positive life changes. PROMPT’s patient engagement model is an effective harm-reduction strategy for the growing opioid use crisis and can improve the health outcomes of marginalized at-risk populations worldwide.
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Introduction Tobacco smoking is a leading preventable cause of morbidity and mortality in Canada and around the world.(1) The effects of nicotine, the pharmacologically active agent in tobacco products, is acutely toxic as nicotine readily enters the body through the lungs and is distributed rapidly throughout the bloodstream.(1) Beyond the addictive properties of nicotine, it activates multiple biologic pathways that play a role in hampering fetal growth and development, the immune system, the cardiovascular system, and the central nervous system; in addition to stimulating carcinogenesis.(1) The life expectancy of tobacco smokers is cut short as smoking is documented to shorten life far more than most other risk factors for premature death; smokers are estimated to lose more than a decade of life in comparison to non-smokers.(1) Despite a steady decline in cigarette smoking since 1964, large disparities in rates of tobacco use remain evident across groups defined by race, ethnicity, education level, and socioeconomic status (SES) and across regions in all high-income countries including Canada.(1-3) Major health disparities exist between smokers and non-smokers and are evident with lower socio-economic status groups having disproportionately higher rates of tobacco use.(4) Globally, disadvantaged groups between the ages of 35 and 69 are much more likely to die from tobacco smoking.(3;5) Tobacco is responsible for about half of the socioeconomic difference in death rates for this age range. (3;6) Specifically, smoking tobacco rates are higher among the long-term unemployed, homeless or at-risk for homelessness, mentally ill, prisoners, single parents, people with limited education, people with low income, and some groups of immigrants and ethnic minorities (7;8) which are more likely to be socioeconomically disadvantaged.(8-12) Poly-substance use and tobacco use are common co-occurrences in homeless or at-risk for homelessness populations in North America.(13) Although the city of Ottawa (Canada) has one of the lowest smoking rates in the Province of Ontario (9-12 %),(14;15) major disparities exist as disproportionately higher rates of tobacco smoking were observed among people who use drugs (PWUD). According to the PROUD (Participatory Research in Ottawa: Understanding Drugs) study of Ottawa inner city residents who use multiple drugs, 96 % of respondents reported they had smoked cigarettes in the past year.(15;16) Furthermore, similar trends are observed in the United States, for example 29% of the general population smoked in comparison to 75-100% for people who abuse alcohol, PWUD, and those receiving methadone maintenance. Many people recovering from poly-substance addictions die from smoking related illnesses.(17;18) Reducing the harm associated with cigarette smoking among lower SES groups creates opportunities for improving the health and well-being of disadvantaged communities, in addition to reducing the disproportionate burden of smoking related illness on the health care system.(11;19) A harm reduction paradigm emphasizes a pragmatic approach to substance use, removing moral judgement, and instead prioritizing health problems associated with substance abuse in order to reduce and minimize individual and societal consequences.(20) Moreover, a harm reduction approach acknowledges that many substance users may never achieve (or even have the desire to achieve) abstinence and that in light of this reality it is important to provide non-abstinence based alternatives to reduce exposure to risk and harm from substance misuse. (20) The success of harm reduction among illicit drug users carries over to tobacco harm reduction efforts, which in addition to a reduction in smoking also includes the use of nicotine replacement therapy (e.g. nicotine patch, gum, inhaler etc.). Among alternative nicotine products, nicotine replacement therapies are the least harmful with a marked reduction in cardiovascular
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disease and negligible carcinogenic risk or risk for acquiring respiratory disease.(21)
Mental illness is strongly associated with the initiation and maintenance of cigarette smoking. (22) Individuals with mental health issues smoke tobacco at an alarmingly high rate, and as a result experience an increased risk for smoking related illnesses. Smokers with mental health issues often start smoking at a younger age, are heavy smokers, and are less likely to participate and succeed in smoking reduction and cessation efforts. In particular, smoking is highly prevalent among individuals with anxiety and/or depression, who are more likely than individuals with other mental health issues to experience failed cessation attempts and relapse post-cessation.(22) Some studies propose a self-medication theory where individuals with mental health issues use substances to cope with their mental illness, while other studies suggest that smoking may act as a catalyst for the development of mental health issues. The opposite is also true as there is evidence that a reduction or cessation of smoking behaviour can improve the physical and mental health related Quality of Life (QOL) of smokers. One study in particular demonstrated a reduction in panic disorder and agoraphobia among quitters;(22) and another demonstrated that smokers were more likely to report poor physical and mental health related QOL when compared to non-smokers and former smokers.(23) Despite well-established benefits of tobacco harm reduction and smoking cessation,(1;24) common misconceptions exist when treating PWUD, for example that smoking cessation will interfere with drug dependence treatment by becoming an additional stressor. Health care providers may bring in their own biases and feel that smoking tobacco is not a priority issue in comparison to other substance use.(17) Yet, research shows that 44-80 % of PWUD are interested in quitting tobacco, 72 % of PWUD reported trying to quit tobacco smoking, and 69 % expressed interest in participating in a group smoking cessation program. Moreover, 82 % of PWUD indicated interest in receiving a prescription for nicotine replacement medication, and among those who considered cessation, approximately 56 % reported being interested in both group intervention and nicotine replacement.(24;25) Therefore, the motivation to quit smoking tobacco exists within the PWUD community - however there is a lack of programs designed to cater to at-risk, drug using, street based individuals. Very few research studies have followed poly-substance users and tracked their smoking activity as well as smoking cessation efforts. Importantly, with the growing crises of opioid use in the US and Canada, novel strategies to deal with the synchronicity of co-addictions are urgently needed.(26-28) Consequently, a community-based participatory action research project was conducted in the inner city population of Ottawa with PWUD.(15) The purpose of the project was to assess the feasibility of implementing a community-based participatory tobacco dependence strategy in Ottawa’s inner city. Feasibility centred outcomes include the impact of the project on the tobacco and poly-substance use of participants, the levels of loss to follow-up in a project that recruits active drug users, and the role of peer researchers in the implementation of the project and in the smoking cessation efforts of participants. Ultimately, the PROMPT project aims to demonstrate that a program focused on tobacco-dependence available in the community with meaningful ‘patient engagement’ of community members representative of the target population is feasible and able to improve quality of life and reduce tobacco use.
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The Participatory Research in Ottawa: Management and Point-of-Care for Tobacco Dependence (PROMPT) project was a feasibility mixed methods prospective cohort study with PWUD using a community-based participatory action model. The study inclusion criteria were: 1) currently living in Ottawa for at least past 3 months prior to enrolment, 2) 16 years or older, 3) have used drugs in the past year (excluding marijuana and alcohol), and 4) had smoked tobacco in the past 7 days. The exclusion criteria included: 1) consent declined (refusal from participant or decision maker); 2) any person accessing addictions treatment (in-patient drug rehabilitation) and hence unavailable for follow up; 3) any person currently or recently (in the past 30 days) enrolled in a smoking cessation program; and 4) anyone with a terminal illness with a life expectancy of less than 3 months. The Ottawa Health Science Network Research Ethics Board approved the study and written informed consent was obtained from all participants. Four individuals with lived experience, members of the PROMPT target population (ex/current tobacco smoker, homeless or at-risk for homelessness, poly-substance user), were selected as community (peer) researchers. The community researchers were selected through a low-threshold, inclusive, and informal interview process. The informal interviews were conducted at the project site with community members. Prospective candidates were assessed for their passion and interest in community wellbeing; prior experience in similar community-based projects was optional. A partnership between community researchers and academics was formed and regular meetings were held throughout the project. All members of the team (including community researchers) participated in the design of the project and questionnaires, including item development, development of strategies for recruitment and retention using a social network approach, data entry, data cleaning, data analysis, preparation of posters/abstracts/handouts, and manuscript preparation and knowledge mobilization. The patient engagement approach used in the PROMPT project, ‘The Ottawa Citizen Engagement and Action Model’ (OCEAM), is described in detail in another publication.(15) The community researchers underwent intensive training prior to participant enrolment. The training focused on privacy, confidentiality, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, harm reduction, the role of peer interviewers, interviewing skills, obtaining study consent from participants, administering surveys with iPads, and administering lung function testing and certification for hand-held spirometry and oscillometry. After the training, community researchers created a list of project requirements that they posted in participant interview rooms as an added measure to adhere to the project’s protocol and procedures. Community researchers were given an honorarium ($15/hour) for the time spent conducting project related activities such as trainings, meetings, consenting, follow-ups, social networking for recruitment and retention, knowledge mobilization, and data cleaning and analysis. Throughout the life of the project, community researchers also navigated their social networks to encourage participants to attend life-skills workshops, nurse counselling, and monthly follow-up appointments.
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The structure of the recruitment strategy, interviewing and point-of-care testing, closely followed the principles of community-based participatory action research. As pairs, community researchers conducted street-based recruitment five days a week assessing eligibility and providing appointment times for enrolment, either on the same day or as per the potential participants’ convenience. Coercion for participation was avoided by pairing of community researchers and through rigorous ethics training. At the baseline visit community researchers acquired consent, administered iPad based baseline questionnaires, two point-of-care lung function tests, and hand-held spirometry and oscillometry. The consent process was conducted at the community research office. Community researchers also administered a monthly iPad based follow-up survey for six months ending with the administration of hand-held spirometry and oscillometry at the last follow-up. Participants were given $20 at baseline enrolment and $25 at each monthly visit to compensate for their time and effort. All participants were enrolled in the Smoking Treatment for Ontario Patients (STOP) program led by the Centre for Addiction and Mental Health (CAMH), Toronto Branch, in order to receive free and ‘off-label’ Nicotine Replacement Therapy (NRT). After providing consent to participate in the PROMPT project participants met with an expert tobacco dependence treatment nurse from the Ottawa chapter of the Canadian Mental Health Association (CMHA). The CMHA nurse was specifically hired for the PROMPT project and was available onsite twice a week to offer one-on-one counselling and individualized NRT available through the STOP program. The participants could meet the nurse as frequently as requested by the participant or as deemed clinically necessary by the nurse. The study followed the current clinical practice of the Canadian Mental Health Association to prescribe and dispense an amount of NRT titrated to suppress nicotine cravings. This could be referred to as "off-label" use of NRT, because the standard prescription of NRT, especially of nicotine patches, is titrated according to the number of daily cigarettes used. The CMHA nurse provided brief counselling sessions (approximately 20 minutes) using motivational interviewing techniques and strategies to help participants strengthen their motivation to change and reduce their dependence on nicotine. The nurse and academic staff also supported participants in their efforts to access housing, health care services, and legal support by writing letters of support and connecting participants to community resources. Lastly, exhaled CO was measured during visits with the nurse using a Bedfont Micro Smokerlyzer for biochemical confirmation of self-reported quitting. To further involve the community, weekly peer-led life skills workshops were conducted on a variety of topics such as financial literacy, banking, peer-support, HIV/Hepatitis C education, pet-care, cooking, mindfulness meditation and art. Community researchers took the lead in organizing and conducting these workshops. Volunteers from community organizations helped facilitate some of the life-skills workshops. In addition, quarterly Community Knowledge Forums were designed and conducted by community researchers and project participants. The knowledge mobilization forums helped disseminate project outcomes and were attended by PROMPT participants, community members, healthcare service provider allies, and occasionally by the local media, the Ottawa Police, and members of the provincial parliament.(29). PROMPT project related activities were conducted at a Community Research Centre, near Ottawa’s largest homeless shelter, located downtown in Ottawa’s popular ByWard market which
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is at the centre of open drug consumption and homelessness. A Community Advisory Committee (CAC) was formed at the centre with five voting members (PROMPT community researchers and participants) and five non-voting members from neighbourhood community healthcare agencies with balanced sex, gender, race, language and indigenous representation. Community researchers reached out to the community to interview and select CAC members. The CAC meets monthly and the members named the Centre appropriately as the Bridge Engagement
Centre (the Bridge), a place to bridge gaps between different communities. Data and Measures
The participants underwent an expired carbon monoxide (CO) test, spirometry, and an oscillometry test at baseline and at the end of the project, 6 months after enrolment. Seven questionnaires were administered by the community researchers to all participants at baseline: 1) demographic information: detailed tobacco smoking history, drug use questionnaire and a social network questionnaire, 2) Fagerstorm Test for Nicotine Dependence (FTND),(30) 3) the BOLD core questionnaire used in the CanCOLD study which aims to evaluate respiratory symptoms (cough, phlegm, whistling/wheezing, shortness of breath),(31;32) 4) Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT): an open-access disease-specific questionnaire,(33) 5) EQ-5D-3L: a well-validated five item questionnaire which measures generic quality of life,(34) 6) Patient Health Questionnaire (PHQ-8): an eight-item open-access questionnaire which is used to establish provisional depressive disorder diagnoses as well as grade depressive symptom severity,(35) and 7) the Generalized Anxiety Disorder (GAD) questionnaire, a 7-item questionnaire to assess generalized anxiety disorder.(15–21) A brief follow-up questionnaire was administered by the community researchers at monthly follow-ups, pertaining to questions regarding current tobacco smoking status and the barriers and facilitators of smoking. The community researchers administered a questionnaire at 6 months to inquire about participants’ overall experience in the project, including perceived changes and challenges experienced by participants’ over the course of the project. All project related materials, including the consent form were in English. PHQ-8: Substance use disorders and depression often occur simultaneously within the same individual.(36) To assess the prevalence and impact for this cohort, an eight-item version of the Patient Health Questionnaire (PHQ-8) was used. The PHQ-8 consists of eight items on which the DSM-IV diagnosis of depressive disorders is based. Each participant answers the 8 questions with four responses (not at all to nearly every day (0 to 3)) assigned to each category. The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0-4 represents no significant depressive symptoms; 5-9 mild depressive symptoms; 10-14 moderate; 15-19 moderately severe; and 20-24 severe.(37) GAD-7: The Generalized Anxiety Disorder 7-Item (GAD-7) questionnaire is a self-administered one-dimensional scale to assess the presence of the symptoms of generalized anxiety disorder (GAD) referred to in the DSM-IV. The score for each of the 7 items ranges from 0 (not at all) to 3 (nearly every day) with a possible total score of 0 to 21. The total score may be categorized into four severity groups: minimal/no anxiety (0–4), 2) mild (5–9), 3) moderate (10–14), or severe (15–21) with an optimum cut-off value for GAD at 10 points.(38)
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EQ-5D-3L: A frequently applied general health status measure is the EuroQol questionnaire (EQ-5D-3L). The EQ-5D-3L was a brief questionnaire used to evaluate the health related quality of life of the PROMPT cohort.(39) The questionnaire consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression which provides a single index value for health status for each individual.(40) The participants were also given a visual analogue scale (EQ-VAS) and asked to rate their health on a 20 cm vertical scale that ranges from 0-100 with 0 representing ‘the worst health you can imagine’ and 100 representing ‘the best health you can imagine’.(40) Data Analyses
The difficulty accessing the target population, the precarious nature of the target population’s living situation, and budget constraints determined the sample size. Potential confounders were included in the development of the study exclusion criteria. A retention rate of 40% with full data collection at the 6-month follow-up was considered adequate for the project to be considered feasible, a priori. As a result of the day-to-day challenges faced by the target population (e.g. housing instability, high incarceration rate, food insecurity, intermittent telephone access etc.) the study investigators estimated a high loss to follow-up, and decided a retention rate of at least 40% was reasonable and in line with the literature on high drop-out rates for smoking cessation projects and projects with low-income communities.(41;42) Other feasibility centered outcomes were based on monthly follow-up data, such as self-reported and biochemically validated tobacco use; the proportion of participants that participated in each follow-up; and the role of peer researchers on project implementation and impact. In particular, the variables used to measure both the primary and secondary outcome include cigarette use per day and exhaled CO as measured by a Bedfont Micro Smokerlyzer, respectively. The monthly follow-up questionnaire included open-ended questions, in order to get as much qualitative feedback as possible from participants. A thematic analysis was conducted in order to identify recurring patterns (i.e. themes) in the data. The themes were determined not only by quantity but also quality in relation to study outcomes. Saturation was achieved when variation decreased, and no new themes emerged from the data.
Statistical analyses were performed using SAS version 9.3. Descriptive statistics were computed to provide an understanding of population characteristics and distribution of the main study variables. Paired t-tests (with Bonferroni correction) were conducted to compare baseline data and monthly follow-up data (six months) on tobacco smoking per day. Baseline illicit substance use was not available because the initial survey asked for drug use ever and not current use. Follow-up data collection captured current illicit substance use. We employed an Intention-To-Treat (ITT) analysis a priori, as we were expecting losses to follow-up.
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Between March and August 2016, the community researchers recruited, consented and completed baseline assessments on 80 participants. The baseline characteristics of the study’s participants are presented in Table 1. Most participants were male (70%), Caucasian (77.5%), and between the ages of 41 and 50. Many of the participants (31.3%) completed their high school education, some of the participants started higher education (26.3%), and a few (5.0%) completed college or university. A large proportion of participants had an average monthly income between $1000-$1999, with many reporting some level of food insecurity as measured by the frequency in which participants experienced hunger and were unable to afford food. Lastly, the majority of participants reported English as their first language. There was no significant difference in baseline demographic data between participants who were followed to project end (n=34) relative to participants lost to follow-up.
Table 1: Demographic characteristics (n=80)
Participant Characteristics Baseline %
(N=80)
Study End %
(N=34)
Loss to Follow-Up %
(N=46)
Gender Male Female
70.0 30.0
59 41
78 22
Age
16-30 31-40 41-50 51-65 N/A
14.8 8.7 44.4 30.9 1.2
12 6 41 41 0
17 11 48 24 0
Ethnicity: Caucasian: First Nations: Inuit: Métis**: East Asian: Other:
77.5 16.3 1.2 1.2 1.3 2.5
71 20 0 3 3 3
83 15 2 0 0 2
Education Grade School/Some High School High School Graduate/GED Some College or University College/University Completed None N/A
33.7 31.3 26.3 5.0 1.2 2.5
35 32 24 6 3 0
33 31 29 4 2 1
Monthly Income <$499 $500-$999 $1000-$1999 $2000-$2999 N/A
11.3 33.7 43.8 10.0 1.2
6 29 56 9 0
15 37 35 11 2
Food Insecurity Always Most of the time Occasionally Sometimes Usually Never N/A*
15.0 11.2 16.3 26.2 10.0 18.8 2.5
18 6 12 26 9 29 0
13 15 20 26 11 11 4
*N/A=missing or refuse to answer; ** Métis - are a group of peoples in Canada who trace their descent to First Nations peoples and European settlers. They represent the majority of those identifying as Métis, though smaller communities also exist in the United States. They are recognized as one of Canada's aboriginal or indigenous peoples under the Constitution Act of 1982, along with First Nations and Inuit peoples.
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In Table 2, baseline information regarding self-reported health conditions, smoking and drug use related data for project participants is provided. Most of the participants at baseline smoked between 15-25 cigarettes daily for a period of 21-30 years, and purchased company branded cigarettes from convenience stores. However, over half of the participants also bought contraband cigarettes from a local dealer. The majority of participants reported using crack and marijuana in their lifetime. Table 2. Baseline tobacco smoking, self-reported health conditions and poly-substance use (N-80)
Participant Characteristics Baseline % (N=80) Study End % (N=34) Loss to Follow-Up %
(N=46)
Number of Cigarettes Per Day <15
15-25
26-35
36-40
N/A*
32.5 42.5 10.0 6.3 8.7
54 7 33 2 4
44 17 35 4 0
Total Years of Tobacco Smoking <10
10-30
31-50
51-60
N/A*
12.5 48.7 32.5 2.5 3.8
0 35 26 2 37
17 50 31 2 0
Cigarettes Purchase
Convenience Store
Local Dealer
66.3 50.0
58 53
71 48
Type of Cigarettes
Company Branded
Contraband Cigarettes
66.3 55.0
62 56
70 54
Money Spent on Cigarettes
<$100
$101-200
$201-400
$400+
N/A*
48.1 28.4 18.5 2.5 2.5
50 32 12 6 0
50 26 24 0 0
Previous or Current Drug Use Crack
Marijuana
Heroine
Fentanyl Oxycontin
66.3 61.3 23.8 13.8 12.5
71 61 21 18 15
64 62 27 11 11
Self-Reported Conditions Heart Disease
Hypertension
Diabetes
Tuberculosis Stroke
Cancer Schizophrenia Depression
Anxiety Disorder Bipolar Disorder Seizures
7.5 5 8.8 1 5 5 3.8 35 28.8 8.8 5
12 6 9 3 9 6 3 47 32 12 6
4 4 9 0 2 4 4 26 26 7 4
*N/A=missing or refuse to answer
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Supplementary Table 1 demonstrates the frequency of depressive symptoms as measured by the PHQ-8, generalized anxiety symptoms as measured by GAD-7, and the generic quality of life as measured by the EQ-5D-3L visual analogue scale. Mild anxiety was estimated to be present in 30% of participants and 32.6% of participants had moderate to severe anxiety scores. Mild depressive symptoms were present in 20% of participants and moderate to severe depression symptoms were present in 15% of participants. Mean EQ-5D-3L Visual Analog Scale was 62.2, with a standard deviation of 17. Supplementary Table 2 shows that the majority of participants accessed at least two types of nicotine replacement therapy (NRT) of the four types of NRT available in the project: the gum, lozenge, inhaler, and patch. While it is expected that participants that followed to study end accessed the most NRT and visited the nurse most often - the costs associated with NRT accessed and visits to the nurse are not substantially greater than the costs incurred by participants lost to follow-up. Supplementary Table 3 provides changes in self-reported tobacco smoking and poly-substance use over the study’s six-month follow-up period. Participants smoked an average of 20.5 cigarettes at baseline in comparison to 9.3 cigarettes at the 6-month follow-up. A paired t-test comparing tobacco use per day at baseline with monthly follow-ups revealed an average reduction of 11.2 cigarettes (p=0.0001) from baseline to study end. Participants also reported reductions in illicit substance use (18.8%.) between baseline and study-end, including a reduction in the opioids heroin (6.3%), fentanyl (2.6%), and oxycontin (3.8%). Drug use data reporting was not uniform, for example some participants reported the use of crack in dollar figures whereas others reported in grams. Community researchers helped translate the dollar figures into grams in order to harmonize data for data analysis.
Figure 1 demonstrates the frequency of participants following up at monthly follow-up visits. Community researchers mobilized their social networks to encourage attendance at follow-up visits. Feedback from participants and community researchers indicated two main reasons for loss to follow up: lack of transportation or food during follow-ups, and loss of participants to incarceration as the target community is subject to higher rates of enforcement for petty crimes and low level drug trafficking and are often targeted by "drug sweeps" before key tourism seasons.
Figures 2 and 3 demonstrate self-reported data from 34 participants at six months regarding changes in smoking and poly-substance use. The tobacco smoking quit rate was defined as biochemically-validated 7-day point prevalence smoking abstinence prevalence at the 6-month follow-up visit. Reduced use for cigarettes smoking and other drug use was defined as self-reported reduction from project enrolment to the last follow-up visit. Data about tobacco use and illicit drug use was collected at monthly follow-up visits and at the final 6-month post project survey. At around the 2nd follow-up, the community researchers were a bit overwhelmed with the number of participants at monthly follow-up visits. The project coordinator (TK) tried to help by administering a few monthly follow-up surveys. However, the community researchers quickly observed that when the project coordinator (TK) conducted the monthly follow-up interview, the self-reported drug use was less than when they conducted the interviews. A decision was made that only community researchers would conduct the monthly follow-up interviews. Out of the
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total recruited participants (n=80), 32.5% (p=0.0001) reported reducing their tobacco use while 18.8% reported reducing their poly-substance use, since the beginning of the program with ITT. Supplementary Figure 1 provides the frequency of participants who reported having problems within each dimension of EQ-5D-3L. Approximately 24.4% of the participants reported problems with mobility, 6.3% with self-care, 15.2% with usual activities, 62.0% with pain, and 55.7% with anxiety. The average EQ-VAS score was 62.2 with a range of 3-100.(36) Supplementary Figure 2 shows the reduction of cigarette use, paralleled by a reduction in exhaled CO levels measured at each participant follow-up over the full study period (11.2 cigarettes, p=0.0001). Exhaled CO monitoring served as biochemical feedback for participants and as objective data on smoking cessation for the project. Qualitative Results Several themes materialized from a thematic analysis of the qualitative data collected during the project’s six-month follow-up period. The first theme that emerged was regarding the role of peer researchers and their impact on participant outcome. Many of the participants believed their progress was due to the support they received from the project’s peer researchers. The peer researchers’ leadership and coordination of monthly follow-ups, outreach, and project related workshops helped create a sense of community and connection that many participants report helped them manage their concurrent addictions. When asked what helped them reduce or quit, many of the participants mentioned the study’s community researchers:
“Felt well supported by Kelly and Tiffany” (Participant 1)
“Outreach by Kelly and Tiffany” (Participant 2)
Moreover, the impact of using a community based approach and peer-to-peer model was touched upon in the data, such as the following quote by a PROMPT participant:
“I really feel like I belong somewhere, I do not like to call it a program, it is a group.
Program feels like something forced upon you, this is so welcoming, I feel like coming
here and I get help.” (Participant 3)
Another theme that was present in the data captured the health benefits of smoking cessation. The following quotes speak to the changes in quality of life experienced by PROMPT participants, after reducing or quitting tobacco and other substances:
“Now that I am smoking less, I did not have to sneak out on my grandkids when I went to
play with them over the weekend. Else, I always had to make up a story and sneak out
hurriedly to take a few puffs, because the cravings were so bad. I had no cravings this
weekend and played for the full four hours with my grandkids, felt so good.”
(Participant 4)
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“My chronic back pain is so much better now that I am smoking only 2-3 cigarettes.” (Participant 5)
During the end of the study many of the participants started to associate smoking with other substance use:
“I didn’t realize that smoking had such a large effect on my breathing and general
health. Now that I think about it everyone who smokes crack or uses [other illicit
substances such as heroin, fentanyl, cocaine etc.] also smokes cigarettes.” (Participant 6) Finally, many of the participants reported that free access to “off-label” personalized Nicotine Replacement Therapy helped them in their efforts to reduce or quit smoking tobacco:
“The NRT was helpful, especially being able to choose whatever mix I needed to help me
kick the habit” (Participant 7)
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Discussion & Conclusion The PROMPT project was a feasibility mixed methods prospective cohort study that describes the detailed psycho-socio-economic variables associated with tobacco smoking and poly-substance use in the most at-risk marginalized inner city population of Ottawa (Canada). The project demonstrated that a comprehensive program focussed on tobacco dependence management available in community and implemented in true partnership with community (peer) researchers is feasible (greater than 40% retention rate) and may even produce outcomes beyond tobacco smoking reduction or cessation. In the PROMPT cohort, participants at baseline smoked an average of 20.5 cigarettes per day. However, with time mean cigarette use reduced significantly (9.3, p=0.0001) in the majority of the participants (see figure 2). Smoking reduction is known to lead to smoking cessation,(43) and thus a longer duration of support may well have produced a higher percentage of smoking cessation in the study cohort. Cessation was defined as smokers with exhaled carbon monoxide ≤ 10 ppm (see figure 2). Moreover, a sizeable number of participants at study-end self-reported a reduction and in some cases cessation of other poly-substance use (18.8%) (see figure 3). Within opioid use a self-reported reduction was observed in heroin (6.3%), fentanyl (2.6%) and OxyContin (3.8%). Participants that followed up the longest were more likely to report a reduction in cigarette smoking and illicit substance use, in addition to an improvement in overall socioeconomic status, relative to participants that were lost to follow-up early in the project. Qualitative findings show that PROMPT participants experienced considerable psycho-socio-economic benefits such as better health (weight gain, improved breathing and physical exercise, enrolments in school and drug treatment etc.) and social outcomes (e.g. returning to the work force, improved housing, reunification with family, greater community engagement etc.). Overall qualitative findings reveal that the quality of life of a third of the participants improved; and that community based research involving peer-to-peer engagement holds the potential for improving health and meaningfully engaging marginalized communities in health research. It is important to note, however, that while observational research has been documented to be consistent with randomized control trials in estimating the magnitude of the effects of treatment (44;45) – the outcomes of the PROMPT project will be further investigated in a pragmatic multi-centre RCT with homeless (at-risk for homelessness) People Who Use Drugs in Canada and the US. It is well known that socioeconomic status in a society influences one’s health and wellbeing. Groups that have been traditionally disadvantaged, such as inner city populations tend to have high rates of tobacco smoking.(8) Furthermore, smoking rates have been declining in Canada, the US and among other high-income countries; however the decline has been slower or nonexistent among low SES groups. Health interventions such as PROMPT tackle social determinants of health that facilitate substance use and poor health. The wide-ranging benefits (e.g. return to work, improved social capital, seeking out health care etc.) of holistic interventions can contribute considerably to the reduction of disparities in morbidity and mortality in marginalized communities with an estimated economic value of $1.02 trillion.(46) This is especially important as the findings of the study show that the majority of participants are relatively young (see table 1) and have been smoking for at least 10 years (see table 2), qualifying the majority of PROMPT participants as high risk for chronic disease burden and many years of productive life lost.
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In clinical settings, tobacco use is strongly associated with poly-substance use.(13) The neurobiology of addiction demonstrates that tobacco may have the strongest physiological pull and thus may be the most difficult to quit. Addiction research speaks to the entangled nature of tobacco and poly-substance use strengthened by shared neurobiological processes that trigger dopamine release in the reward pathway of the brain creating pleasure and an additive effect that enhances enjoyment and dependence.(47) Adolescent research and animal studies confirm the ‘gateway to illicit drugs’ hypothesis that suggests the introduction of tobacco at an early age increases the likelihood of future illicit drug use.(48-50) Moreover, epidemiological research on addiction reveals better treatment and recovery outcomes for poly-substance users that quit tobacco use in comparison to counterparts that continue to smoke tobacco.(51-53) The potential for tobacco use reduction and quitting to lead to the reduction and quitting of other poly-substance use (as seen in PROMPT participants) is thus neuro-biologically plausible.(1) Studies in various clinical populations have reported high rates of tobacco use among persons with depression and anxiety.(54) According to research, current smokers were 2.5 times more likely to have an anxiety disorder; however, if they were former smokers there is no significant difference in the odds of having an anxiety disorder.(54) As noted in the PROMPT cohort, 30.0% reported mild anxiety, 18.8% reported moderate anxiety, and 13.8% reported severe anxiety (see supplementary table 3). According to Statistics Canada, the lifetime prevalence of GAD in the general population is approximately 5% in Canada.(55) Furthermore, the high comorbidity of anxiety and depressive disorders and the high correlation between depressive and anxiety measures is well known. Not surprisingly, our depression measure, the PHQ-8, strongly correlated with the GAD-7 and therefore in the PROMPT cohort we observed that 37.5% had mild depressive symptoms, 20.0% had moderate depressive symptoms, and 12.5 and 1.25% had moderately severe and severe depressive symptoms, respectively (see supplementary table 3).(35) There is no dearth of literature that documents that both neurobiological and psychosocial factors reinforce the use of nicotine in people with psychiatric illnesses.(56;57) For individuals with chronic mental illness, smoking is a major part of their daily routine and is an activity that provides some structure and a sense of routine to a day with few activities.(56;57)
The PROMPT project utilized a community-based participatory action approach with meaningful ‘patient engagement’ with community (peer) researchers that were truly representative of the study’s target population. The PROMPT community (peer) researchers were seen as confidants and were able to encourage participants by providing examples of their own struggles and the successes they experienced in their personal journeys to recovery. With complex social determinants of health at play in the PROMPT population, the project’s community-based participatory approach allowed PROMPT participants to develop social networks and enhance their knowledge of available community resources and supports. Furthermore, the participants found that the various community capacity building events and activities led by their peers encouraged their continued engagement and provided them additional support, if and when they needed it. According to Davidson et al, peer support staff are viewed more like friends than non-peer case managers or clinical staff for several reasons, a major one being that they share personal stories with the participants which allows for the development of social relationships. Furthermore, the relationships community (peer) researchers developed with participants was reciprocated as both parties learned from each other and provide support to one another.(58)
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Future research and additional programming is required to understand the mechanisms by which interventions such as PROMPT help marginalized hard-to-reach inner city populations. A community-based participatory action research approach, “by the people, for the people”, is promising as it provides a novel approach to complex public health issues such as poverty and isolation leading to homelessness, tobacco smoking and poly-substance use. The PROMPT project’s patient centered, personalized, tailored approach to dispensing NRT and developing a quit plan and supports appropriate for active drug users is difficult to replicate in a clinical setting and necessitates a community based approach. The project’s success recruiting, engaging, and potentially influencing the health outcomes of a highly vulnerable hard-to-reach population surpassed initial expectations of feasibility and tobacco reduction and cessation. The impact of the project speaks to the need for additional, personalized, and holistic community based peer-led support to reduce health inequities in marginalized communities.(59) The PROMPT model’s holistic and compassionate approach can also be used as part of the strategy dealing with the growing opioid crises in the US and Canada.(60) Additionally, the model holds the potential to be adapted for other complex and chronic health issues such as diabetes and obesity in different populations and in different settings including community-based integrated care.
Study Limitations & Delimitations A limitation of the project was that it was conducted in one inner city setting. Nonetheless, many of the inner city populations across the US and Canada have a demographic profile similar to the participant profile in the PROMPT project. Thus, the project can be implemented in similar settings across the US and Canada. Additionally, a larger study with a greater sample size will need to be conducted to demonstrate an effect on clinical outcomes. Lastly, while the findings are promising, the lack of a control limits the inferences that can be made from the study results. The PROMPT study was a mixed method feasibility study designed to lay the foundation for a Randomized Clinical Trial (RCT). A plan is underway to conduct a pragmatic multi-centre randomized control trial (RCT) to examine the impact and potential of the PROMPT model.
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Acknowledgments and Disclosures We are indebted to all of our PROMPT community researchers, without their trust in the academic research team and dedication towards harm reduction this project would not have been possible. PROMPT participants demonstrated resilience throughout the project; and despite their day-to-day struggles they kept coming for follow-ups, we are so very grateful for your inner strength. We thank Dr. Peter Selby and his team at the CAMH in Toronto, Canada for their belief in the PROMPT model and support through the STOP program. We are also thankful to the Ottawa chapter of CMHA for providing excellent nurses for our project. To our local healthcare allies: the Shepherds of Good Hope, Ottawa Inner City Health Inc., Sandy Hill Community Health Centre (CHC), Somerset West CHC, we could not have implemented the project without your in-kind support. Our Community Advisory Committee at the Bridge, comprised of K. McNaughton (Ottawa Inner City Health Inc.), R. Boyd (Oasis, Sandy Hill CHC), S. Willmott (Somerset CHC), J. Haddad (CMHA), S. Pakhale (PROMPT lead scientist), Tara, Rick, Ted and Petrina (PROMPT participants) and K. Florence (a PROMPT community researcher), meets monthly at the Bridge and guides the mission and vision of the space along with overseeing the smooth functioning of all projects. We are indebted to the vision, dedication and passion of the Bridge CAC. We are thankful to the Ottawa Hospital, especially Dr. Jack Kitts, Dr. Jim Worthington, Dr. Jeff Turnbull, Dr. Mike Tierney, Dr. Bill Cameron, Dr. Ian Graham, Dr. Antoine Hakim and the administrative staff for administrative and moral support in maintaining our community space, the Bridge Engagement Centre. We thank the EuroQol questionnaire team (EQ-5D-3L) for allowing us to use the questionnaire pro-bono for this project. Last but certainly not least we are very grateful to all the reviewers of this manuscript, your feedback has been immensely helpful.
No competing interests
Funding: This work was supported by the Champlain Local Health Integration Network; Department of Medicine and the Divisions of Respirology and Cardiology at the Ottawa Hospital, Ottawa, Canada. "All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work." All available data can be obtained by contacting the corresponding author.
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Table Legends Table 1: Demographic characteristics (n=80) Table 2: Baseline tobacco smoking, self-reported health conditions and poly-substance use Supplementary Table 1: Results from the baseline GAD-7, PHQ-8 and EQ-5D-3L questionnaires Supplementary Table 2: Access to Nicotine Replacement Therapy, Canadian Mental Health Association Nurse, and Associated Costs Supplementary Table 3: Mean cigarettes per day (CPD) and poly-substance use data at monthly follow-ups collected at the same time point (Intention-To-Treat Analysis) Figure Legends
Figure 1: Frequency of participants following up monthly up to six months Figure 2: Poly-substance use and tobacco smoking at the 6 month follow-up visit Figure 3: Poly-substance use trend over six months Supplementary Figure 1: Frequency of participants reporting each dimension of the EQ-5D-3L at baseline Supplementary Figure 2: Mean cigarettes per day and exhaled CO per month of six month study duration.
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Participants 13* (a) Report numbers of individuals at each stage of study—eg numbers potentially eligible, examined for eligibility,
confirmed eligible, included in the study, completing follow-up, and analysed 13
(b) Give reasons for non-participation at each stage 13
(c) Consider use of a flow diagram 13
Descriptive data 14* (a) Give characteristics of study participants (eg demographic, clinical, social) and information on exposures and
potential confounders 6
(b) Indicate number of participants with missing data for each variable of interest 10-11
(c) Cohort study—Summarise follow-up time (e.g., average and total amount) 7-9
Outcome data 15* Cohort study—Report numbers of outcome events or summary measures over time 10-15
Case-control study—Report numbers in each exposure category, or summary measures of exposure N/A
Cross-sectional study—Report numbers of outcome events or summary measures N/A
Main results 16 (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95%
confidence interval). Make clear which confounders were adjusted for and why they were included N/A
(b) Report category boundaries when continuous variables were categorized N/A
(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period N/A
Other analyses 17 Report other analyses done—eg analyses of subgroups and interactions, and sensitivity analyses N/A
Discussion
Key results 18 Summarise key results with reference to study objectives 17-19
Limitations 19 Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction
and magnitude of any potential bias 19
Interpretation 20 Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results
from similar studies, and other relevant evidence 17-19
Generalisability 21 Discuss the generalisability (external validity) of the study results 17-19
Other information
Funding 22 Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on
which the present article is based 20
*Give information separately for cases and controls in case-control studies and, if applicable, for exposed and unexposed groups in cohort and cross-sectional studies.
Note: An Explanation and Elaboration article discusses each checklist item and gives methodological background and published examples of transparent reporting. The STROBE
checklist is best used in conjunction with this article (freely available on the Web sites of PLoS Medicine at http://www.plosmedicine.org/, Annals of Internal Medicine at
http://www.annals.org/, and Epidemiology at http://www.epidem.com/). Information on the STROBE Initiative is available at www.strobe-statement.org.
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