Time Differences in the Recognition and Reporting of Symptom Changes Between

CHF patients on Telehealth and Those on Traditional Homehealth

Research Proposal, Presented ByCollins Uzuegbu

March 10, 2011

Objectives

• Part I: Specific Aims of the Research Study– Problem, aim of the study, research question,

research variables, and funding source• Part II: Background and Significance of the study

– Lit review– Conceptual framework

• Part III: Research Methods– Methods, Setting & Sampling Plans– Subject selection, recruitment, & Ethical Matters– Plans for Data Collection & Analysis

Part ISpecific Aims

• Problem Statement:– The yearly cost of treatment for congestive heart

failure (CHF) or heart failure (HF) in the United Sates as of 2006 was at least $34.8 billion, i.e. more than the yearly budgets of Bulgaria, Ethiopia, and Jordan put together

– The American Heart Association (AHA): cost of treatment for heart diseases to triple to $818 billion by 2030

– Medicare spending $17 billion annually in cost of readmissions secondary to CHF & co-morbidities assoc. with the aging population

Barnason, Zimmerman, Nieveen, and Hertzog (2006); Central Intelligence Agency, (2011); Cortez (2011); (Jencks et al., 2009)

Part I Cont…• The recession and spending cut:

– Regressive Medicare reimbursement system for hospitals: up to 20% withheld if readmission occurs within one week of discharge

– Hospitals and health agencies getting wiser with follow-up treatment by• Re-inventing homehealth• Remote symptom monitoring:

Telehealth/Telemonitoring/E-health (TH/TM/EH)– Research findings: The technology is embraced by

patients; reduces readmissions (alerts patients about symptom changes), and offers comparative quality care traditional homehealth (THH)

– Many comparisons already made between TM and THH: but none about time of symptom reporting

(Baucus, 2009); (Nahm, 2008); (Dansky, Vasey, & Bowles, 2008; McGhee & Murphy, 2010)

Part I Cont…

• Purpose of the Research: to examine the potential time differences in the recognition and reporting of symptom changes to the healthcare provider (or emergency care) between CHF patients receiving home telehealth services and those receiving regular home health

• Research Question: Is there a time difference in the recognition and reporting of symptom changes to the healthcare provider (or emergency care) between CHF patients receiving home telehealth services and those receiving regular home health?

Part I Cont…

• Research Variables:– Independent Variable (IV): Telemonitoring devices– Dependent Variable (DV): Time of symptom

recognition and call for medical assistance by CHF patients

• Possible Funding Source: The National Institute of Health (NIH)

Part IILiterature Review

1. Delaney and Apostolidis (2010): Focus: a quasi-experimental study to test the feasibility & effectiveness of the H.E.A.R.T initiative. Result: HEART group showed improved QOL and decreased depressive symptoms vs control group (F = 8.99, P = .007; F = 35.10, P = .001); Lower readmission rates (16% vs 25%), high patient acceptance of the program

2. Gambetta, Dunn, Nelson, Herron, and Arena (2007): Focus: Quantitative study on the Effects of TM on the management of HF in older adults. Result: Ave. no of calls and % med. compliance of TM vs HF clinic groups (159.6±84.5% Vs 92.3±16.5%); rehospitalization risks (hazard ratio, 4.0; 95% confidence interval, 2.4–6.7; P<.001)

3. LaFramboise, Woster, Yager, and Yates’ (2009): Focus: a qualitative study on patients’ perspectives on TH (Health Buddy®). Result: Participants think the device was cumbersome and intricate; credited the device, not their Physicians, for increased knowledge and avoidance of complications; device was “caring;”

Part II Cont…4. Nahm et al. (2008):

Focus: Single group exploratory , quantitative study of HF pts’ eagerness to use eHealth and potential benefits of e-health program on pts’ disease management skills. Result: After HF web-based tutorial, confidence in using eHealth devices was higher post tutorial VS before tutorial with means of 27 (range, 3-30) and 7.6 (range, 1-10)

5. Dansky, Vasey, and Bowles (2008): Focus: an investigative, quantitative study of the effects of TH on self-care of HF older adult pts. Result: Using the general linear model (GLM), pts in the TH group showed greater self-confidence in HF management than pts in control group(THH). Per 9 ordinary least squares regressions, TH pt’s rising confidence predicted (5 out of 9 times) their ability to self-care.

Part II Cont…

6. Poses and Avitall (2003): Focus: A quantitative, randomized controlled trial to determine if TM results in lowered cost and improved health outcome for HF pts. Result: TM group had less hospital readmissions (13 vs 24, P ≤ 0.001); admission period was shorter (49.5 d vs 105.0 d, P ≤ 0.001) compared to THH group

7. Bowles, Holland, and Horowitz (2009): Focus: Prospective, randomized, quantitative, comparison of THH to home health via telephone and home care TM for CHF and diabetes patients. Result: The comparison between TM and control groups was unremarkable (P = 0.69), but the comparison of telephone to THH over 60 days post discharge showed a difference (P = 0.07), including higher risk of rehospitalization (risk ratio = 2.2; 95% CI: 0.9 to 5.2).

Part II Cont…8. Wooden et al. (2008):

Focus: Randomized, controlled trial to test the impact of TM on quality of care and health care cost for heart disease (HF & angina) pts. Result: One year result showed that HF pts in the TM group had less chance of developing class 3 or higher angina than HF pts in THH group. At 3 months and 1 year, angina patients in the study group saw a 51% and 45% reduction in hospital admission rates (P= .02; p=.02), respectively than the control group. Overall, the combined (1 month, 3-month, and 1 year) data for HF and angina groups showed remarkably better QOL than control group patients on majority of SF-36 subscales.

• Conceptual Framework:– Nahm et al. (2008) : TTM: Pts’ willingness to use devices– Delaney and Apostolidis (2010): Self-care for Health Promotion

in Aging (S-CHPA): devp. interventions to promote self-care– Dansky, Vasey, and Bowles (2008) used the Self-Care Model by

Riegel et al. (2000).

Part II Cont…• Conceptual Framework:

Self-Care Model by Riegel et al. (2000): based on the assumption that self symptom recognition is the principal component of self-care management.Five Premises/Constructs:

• Stage 1: Symptom monitoring (including Telemonitoring)

• Stage 2: Symptom recognition– 2a: Symptom reporting (added for this study)

• Stage 3: symptom evaluation• Stage 4: Treatment implementation• Stage 5: Treatment effectiveness (outcome)This model will be used in this study to conceptualize the patients’ active,

participatory role in their personal care.

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Part IIIResearch Methods

• This study will be a quantitative, nonexperimental, retrospective, descriptive, comparative research to examine potential time differences in the recognition and reporting of symptom changes to the healthcare provider (or emergency care) between CHF patients receiving home telehealth services and those receiving regular home health. This method is appropriate because, according to Polit and Beck (2008), “Nonexperimental (or observational) research includes descriptive research - studies that summarize the status of phenomena…” (p. 282). They also remarked that “The purpose of descriptive studies is to observe, describe, and document aspects of a situation as it naturally occurs and sometimes to serve as a starting point for hypothesis generation or theory development” (p. 274).

Part III Cont…Setting

• The setting for the proposed study will be in the in-patient units and emergency department (ED) of a large, level I Magnet® hospital in the Midwest. Acuity of the hospital’s in-patient admission and ED visits range from minor sickness to life-threatening traumas and major injuries. The hospital is surrounded by several healthcare facilities, including group and solo primary care practices, ambulatory clinics, and at least six stand-alone homehealth agencies serving a large number of homehealth and TM patients.

(Miami Valley Hospital, 2009)

Part III Cont…Population (Accessible &Target)

• In 2009, the hospital of the proposed study had approximate yearly total in-patient admissions and ED visits of 38,000 and 118,000, respectively (accessible population) (Miami Valley Hospital, 2009). Most of the admissions and ED visits at the hospital, the largest cardiac emergency center in the region, were adult patients. Many of those adult patients were at least 55 years old (target population), hence the PI should be able to recruit a projected 260 older adult CHF patients into the one year data collection period for the study.

Sampling Procedures & Inclusion/Exclusion Criteria• The sample will include older adults ages 55 to 75 who met

these inclusion criteria (in the data year): spoke English, had New York Heart Association functional classification of at least class II HF, SOB and edema responding to medication, echocardiographic evidence suggestive of HF, lived at home, was under the care of a home health agency, must have used the telehealth device for 3 months preceding the January beginning the one year period, must have been cognitively sound as reported in the neurological assessments done in the year of the data; must have had at least two nurse visits per week in the year of the data (control group only), and volitional participation in the study. Exclusion criteria: Having any of the following conditions before or during the one year data period: HIV/AIDS, cancer, dementia, open wounds, obesity, bed bound, extended living facility residence, and drug use, under 55 or above 75 years old.

• Sampling plan – purposive, convenience sampling of all available adults who meet the above inclusion criteria.

Procedures/Recruitment…• The PI will inform the leadership of the relevant homehealth

agencies, the hospital medical records department, patient safety and privacy office, and the nursing education and research center verbally and by written information posted on the bulletin board of the proposed study. Research assistants at the hospital education and research office, and the PI will call pts who meet the inclusion criteria, or their legal, responsible adult representatives (HCPOA), and briefly introduce the study and obtain a verbal (over the phone) intent to participate pending receipt of the IC in the mail.

• The IC document will be mailed to the pts or their HCPOA in an opaque envelop, including a return envelop. A telephone number will be provided in the document to call in case they have questions about the study. The original copy of the IC will be mailed back to the consenting patients with a $10 compensatory, gas card, while the PI keeps a copy for records purposes.

Procedures/Recruitment…

• Next, a copy of the pt’s signed IC and authorization to release pertinent clinical data will be mailed to each of their homehealth companies in the one year spanning the year of the data of interest.

Ethical Considerations to Maintain the Integrity of the Study

• Approval will be received from the Institutional Review Board (IRB) at Wright State University (WSU) and Review Board or Screening Committee at the hospital prior to the conduct of this study.

• The PI has recently completed the CITI online “Human Subjects” training required for all studies – See attached copy of certification.

• No one other than the PI, research assistants, secretary or data entry clerk, and Statistical Consultation Center at WSU will have access to these data.

• All identifying patient data will be kept confidential and stored in a secure database created exclusively for this study and will not be shared with any other party except those mentioned above.

Measurement/Instrumentation• The following instruments will be used to measure the study variables

in this research grant proposal. – Descriptive statistics will include: Measures of central tendency

(mean, mode, median, frequency, %, SD, variance, and range.– Inferential statistics will include: ANOVA, Chi square,

KaplanMeier , univariate Cox regression analysis, and The Self-Care of Heart Failure Index (SCHFI)

• The descriptive statistics will measure the subjects’ sociodemographic data and other main variables of interest. Mean and SD will be calculated for the two data collection periods, six months apart. ANOVA will be used to measure differences between the intervention and control groups in terms of age, race, and gravity of illness. Chi square will test differences in baseline variables and trend in hospitalization or ED visits between the two groups, while KaplanMeier and univariate Cox regression analysis measures differences in time of symptom onset and reporting between the two groups. For analysis purposes, all statistical tests with P value <0.05 will be discarded. Finally, the SCHFI will be used to measure the subjects’ self-confidence and self-care management skills. The SCHFI has reported Chronbach’s alpha coefficients of 0.56-0.82.

Data collection

• Data will be collected by the PI and research assistants by review of one-year ED, in-patient, and homehealth care records in the following manner:– Basic patient’s socio-demographic data on admission

including vital signs and physical assessment data. Data obtained with every home nurse visits or as measured by the telehealth devices, such as vital signs, weight, heart and lung sounds, neurological and mental status exams, assessment of overall cardiovascular status including presence of edema, shortness of breath, and pain assessment. Information about any treatments or procedures performed in the course of the visits will be collected. Finally, data related to education encounters such as fluid balance, expected course of the disease and reportable symptoms will be collected as documented and entered into the research database.

Data Analyses Plan

• Data will be analyzed using parametric and non-parametric statistics to measure the study variables– Non-parametric statistics include: mean, median, range,

standard deviation, percentage, and frequency– Parametric statistics most appropriate for this study are:

ANOVA, which is used to analyze differences from several variables.

Data collected by the RA’s will be transmitted to andinterpreted by WSU Statistical Consultant Center inconsultation with the PI