Saint Louis University School of Medicine A. Bonifacio StreetBaguio City, Philippines 2600(063) 74 444 8246 to 48

In partial fulfilment for the requirements ofMETHODS OF RESEARCH II

RESEARCH PROTOCOL

Submitted To:DR. JOHN ANTHONY DOMANTAY

Submitted by:Group 12Awao, Jhozel Kim Balabag, Endoken Cabaling, Reiva Geen Diego, LilianGacutan, Glenn Rudolph Nobleza, Chelsea Suguitan, Ryan James Tolero, ArlynTuzon, Ferdinand

19 December 2015I. General Information

Title: Self-reported Patient Safety Competence among Senior and Junior MedicalInterns of Saint Louis University- Hospital of the Sacred Heart

Principal Investigator: Cabaling, Reiva Geen

II. Background and Rationale

Patient safety is a healthcare discipline that emphasizes the prevention of medical error that often leads to significant morbidity and mortality1, 2. The Quality in Australian Health Care Study (QAHCS) found an adverse event rate of 16.6% among hospital patients, while New Zealand and Canadian studies have reported adverse event rates of10%1. The Harvard study, found that 4% of patients experience adverse effects, 70% of which result in short-lived disability, and 14% of incidents lead to death1. WHO reports that developing countries have a higher probability of adverse events in healthcare than industrialized nations due to the higher likelihood of having poor infrastructure and equipment, unreliable supply and quality of drugs, shortcomings in waste management and infection control, poor performance of personnel because of low motivation or insufficient technical skills, and severe under financing of essential operating costs of health services1. Health-care associated infections, misdiagnosis, delays in diagnosis, injury due to instrumentation, and medication errors are just some of the medical errors commonly encountered 3 making patient safety a larger concern in the last few decades 4.

Patient safety is central and a global issue affecting countries regardless of level of development 3. It is centered on the six socio-cultural areas namely: contribute to a culture of patient safety, work in teams for patient safety, communicate effectively for patient safety, manage safety risks, optimize human and environmental factors, and recognize and response to and disclose adverse events 5. Indeed, patient safety has emerged as a distinct healthcare discipline supported by an immature yet developing scientific framework. There is a significant transdisciplinary body of theoretical and research literature that informs the science of patient safety 5. It is critical in providing quality healthcare, thus the need for urgent patient safety reform 6.

Learning about patient safety mostly occurs when trainees are confronted with actual patient safety problems. Most medical curricula are arranged is such a way that students become progressively independent because with the increase in independence , students will also be increasingly confronted with problems concerning the safety of patients particularly during the transition from clerkships to residency 7. Effectively

Page 3 of 6integrating patient safety science into the training programs of healthcare professionals is essential for advancing this reform and the need to transform medical education to ensure that students are equipped with the knowledge, skills and attitudes they need to function safely has been recently outlined by numerous bodies such as the WHO stressing the need to incorporate patient safety teaching into medical school curricula 5, 8, 9.

A systematic review of patient safety curricula in medical school demonstrated that most teachings on patient safety were given by clinicians, ethicists and medical education experts during the third year of medical school allotting 4 -30 hours. They concluded that current curriculum does not meet the standards set by the WHO 9. Another study on medical students preferences for patient safety learning showed preference on supported discussions of real life mistakes and 70% supported internet-based learning while blogging and role playing were less likely preferred. Other studies demonstrate that much of student learning regarding patient safety is informal and usually are students witnessing errors making some authors propose witnessing the various ways in which mistakes are handled is an effective way to integrate patient safety learning into the medical school curricula 10, 11, 12.

As efforts to include patient safety in health professional education increase, it is important to capture trainees and new health professionals perspectives of their own Patient Safety knowledge and competence 8. The perspectives of medical students and post-graduate trainees on patient safety is important in evaluating which patient safety concepts are integrated and actualized in medical education 4. The evolution of learners perspectives is also important in reforming patient safety education 4. Most literatures only report investigations of post-graduate teachings of these topics and a few literature about undergraduate medical education 10. A number of studies regarding Patient Safety Knowledge, Attitudes and Skills have been published in other countries but none in the Philippines. The study then aims to determine the self-reported patient safety competence of junior and senior medical interns of Saint Louis University- Hospital of the Sacred Heart.

III. Goals and Objectives

General Objective:

To determine the self-reported patient safety competence of senior and junior medical interns of Saint Louis University Hospital of the Sacred Heart.Specific Objectives:

1. To determine the self-reported patient safety competence across the H-PEPSSdimensions

2. To determine if there is a significant difference between senior and junior medical interns on the self-reported patient safety competence in relation to:a. Ageb. Genderc. Year leveld. Undergraduate course e. Training/s attended

IV. Design

This will be a Cross-Sectional Study. The respondents will be senior and junior medical interns of Saint Louis University Hospital of the Sacred Heart. A sample size of Ninety- nine (99) participants out of 133 of the total population was calculated using the Statistical Software OpenEpi. The respondents will be selected by simple random sampling.

V. Methodology

A modified version of the Health Professional Education in Patient Safety Survey (H-PEPSS) which was developed by the Canadian Patient Safety Institute (CPSI) will be adapted for the proposed research study. It is a questionnaire which was first developed and pilot tested at the York University with the aim of assessing the health professional students exposure to the six core domains of the Safety Competencies Framework and students perspectives on patient safety.

The research will be completely anonymous and there are no various adverse effects or risks on the part of the participant because it only seeks out perspectives of senior and junior interns in the medical profession on ways which patient safety is addressed. There will be no direct benefit, but it is likely to help the researchers find out more about self-reported patient safety competence in Saint Louis University Hospital of the Sacred Heart.

The inclusion criteria for the participants of the study will be the Junior interns and Senior Interns who are currently having their rotation at Saint Louis University Hospital of the Sacred Heart for the school year 2015-2016. Exclusion criteria would include Junior Interns who are having their community rotation and are currently rotating in other hospital in the conduct of the study.

VI. Safety of Research Subjects/Participants

The research will be completely anonymous and there are no various adverse effects on the participant because it only seeks out perspectives of senior and junior interns in the medical profession on ways which patient safety is addressed.

VII. Data Management and Statistical Analysis

Data ManagementThe various data gathered from the questionnaire shall be tallied by the researchers. The questionnaire was divided into four sections as follows:

Section 1: Learning about specific patient safety content areas. There are seven areas of competence regarding keeping patient safety which includes clinical safety, culture of safety, working in teams with other health professional, communicating effectively, managing safety risks, understanding human and environmental factors and recognizing and responding to and disclosing adverse events and close calls

Section 2: How broader patient safety issues are addressed in health professional education

Section 3: Comfort speaking up about patient safety

Section 4: Demographic information

Data AnalysisTo limit a reduction in sample size, the more conservative unpaired t-test will be used to assess for statistical significant differences between the two groups. One-way analysis of variance will be used to compare difference across programme years.

VIII. Ethical Considerations

The respondents of this research will participate only upon the approval of theEthics Committee of the Research Unit of Saint Louis University.The participants participation in the research is entirely voluntary. It is their choice whether to participate or not. If the participants choose not to participate all the services they receive at this Centre will continue and nothing will change.

IX. Problems Anticipated

However not a major problem in the implementation of this research, time conflict with the availability of senior and junior medical interns with those of the members of the research team is anticipated. Effective communication with the participants as to the schedule of floating questionnaire survey will be handled by the researchers. We do not foresee any major difficulties in implementing this project.

X. Dissemination of results and publication policy

This research aims to publish results through peer-reviewed journals and further disseminate results through research conferences. The outcomes of this research primarily targets medical students, medical interns, practicing physicians, allied health workers, hospital institutions, concerned policy makers and health administrators with unified goals of promoting patient safety competence. Furthermore, this study will strengthen promotion safety because it does not only seek out the clinical safety issues (e.g. hand hygiene, transferring patients, and medication safety) but also system issues that affect safety (e.g. aspects of the organization, management, and work environment). In doing so, this research also aspires to support the international efforts of WHO to place patient safety issues centrally in the countrys agenda by contributing to the research and promoting patient safety issues in this country that affect millions of people in order to develop better solutions and solve specific problems regarding patient safety.

XI. Disclosure of Potential Conflict of Interest

The investigators declare that there is no potential source of conflict of interest.

XII. Financing of project and other support

This research project will be financed by the investigators.

XIII. Collaboration with Other Scientists or Research Institutions

This is a stand-alone project.

X1V. References

1. "World Alliance for Patient Safety". Organization Web Site. World HealthOrganization. Retrieved 2008-09-27.2. Teigland C, Blasiak R, Wilson L, Hines R, Meyerhoff K, Viera A. Patient safety and quality improvement education : a cross-sectional study of medical students preferences and attitudes. BMC Medical Education. 2013: 13:16. DOI: 10.1186/1472-6920-13-16

3. Correction to Advancing Measurement of Patient Safety Culture. Health ServicesResearch. 2009; 44(1):321-321.4. Doyle P, VanDenKerkhof E, Edge D, Ginsburg L, Goldstein D. Self-reported patient safety competence among Canadian medical students and postgraduate trainees: a cross-sectional survey. BMJ Qual Saf. 2015;24:135-141 DOI:10.1136/bmjqs-2014-0031425. Patrick A. Palmieri; et al. The anatomy and physiology of error in adverse healthcare events. Advances in Health Care Management. 2008:7: 3368. doi:10.1016/S1474-8231(08)07003-16. Liane R Ginsburg, Deborah Tregunno, Peter G Norton. Self-reported patient safety competence among new graduates in medicine, nursing and pharmacy. BMJ Qual Saf doi:10.1136/bmjqs-2012-0013087. Thain S, Ang S, Ti L. Medical students' preferred style of learning patient safety.BMJ Quality & Safety. 2011; 20(2):201-201.

XV. AppendixPROTOCOL SUMMARY SHEET

Patient safety (PS) is very critical in effective and quality health care delivery. This study seeks to study reports on PS competence among senior and junior medical interns of Saint Louis University Hospital of the Sacred Heart. Specifically, this is to determine the self-reported patient safetycompetence across the Health Professional Education in Patient Safety Survey (H-PEPSS) dimensions and to determine if there is a significant difference between senior and junior medical interns on the self-reported patient safety competence in relation to age, gender, year level, undergraduate course and training/s attended. The study will be a cross-sectional study employing senior and junior medical interns of SLU-HSH. The (H-PEPSS) will be administered to the participants. Data gathered will then be tallied and analyzed using unpaired t-test to compare statistical difference between the two groups. One-way analysis of variance will be used to compare difference across programme years. The research will be approximately 120 days or four months including floating of questionnaire survey, statistical analysis of data and correlation of findings to literature available. Expected outcomes include above average confidence of both groups in their learning of clinical safety skills (e.g. hand hygiene) and in learning about sociocultural aspects of safety (e.g. understanding human factors) due to the fact that students confidence in most aspects of safety improved with years of training. Other dimensions in the questionnaire (e.g. teamwork, culture, communication and authority) may show average results.

Informed Consent Form for Senior and Junior Medical Interns of Saint Louis University Hospital of the Sacred Heart

This informed consent form is Senior and Junior Medical Interns of Saint Louis University- Hospital of the Sacred Heart and who we are inviting to participate in the research titled Self- reported Patient Safety Competence among Senior and Junior Medical Interns of Saint Louis University- Hospital of the Sacred Heart

Name of Principle Investigator: Reiva Geen CabalingName of Institutional Affiliation: Saint Louis University School of Medicine

This Informed Consent Form has two parts: Information Sheet (to share information about the study with you) Certificate of Consent (for signatures if you choose to participate) You will be given a copy of the full Informed Consent FormPart I: Information Sheet

IntroductionWe are the Third Year Saint Louis University School of Medicine students. We are doing research on self-reported patient safety competence. We are going to give you information and invite you to be part of this research. You do not have to decide today whether or not you will participate in the research. Before you decide, you can talk to anyone you feel comfortable with about the research. This consent form may contain words that you do not understand. Please ask us to stop as we go through the information and we will take time to explain. If you have questions later, you can ask any member of the research team.

Purpose of the researchAs efforts to include patient safety in health professional education increase, it is important to capture trainees and new health professionals perspectives of their own Patient Safety knowledge and competence. A number of studies regarding Patient Safety Knowledge, Attitudes and Skills have been published in other countries but none in the Philippines. The study then seeks to determine the self-reported patient safety competence of junior and senior medical interns of Saint Louis University- Hospital of the Sacred Heart. This is to broaden knowledge on patient safety practices among senior and junior medical interns in the aforementioned institution. In this regard, it also seek to accomplish knowledge about patient safety competence in contrast with different variables and how this affects competent exercise of promoting patient safety.

Type of Research InterventionThis research will involve your participation in a questionnaire survey that will take about 12 minutes to complete.

Participant SelectionYou are being invited to take part in this research because we feel that your experience as a senior or a junior intern can contribute much to our understanding and knowledge of patient

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safety competence.

Voluntary ParticipationYour participation in this research is entirely voluntary. It is your choice whether to participate or not. If you choose not to participate all the services you receive at this Centre will continue and nothing will change.

ProceduresA. We are asking you to help us learn more about self-reported patient safety competence in Saint Louis University Hospital of the Sacred Heart. We are inviting you to take part in this research project. If you accept, you will be asked to answer a questionnaire survey for approximately 12 minutes. This survey will seek your perceptions and opinions only. There are no right or wrong answers.

B. You will fill out a survey which will be provided by and collected by any member of the research team. You may answer the questionnaire yourself, or it can be read to you and you can say out loud the answer you want me to write down. If you do not wish to answer any of the questions included in the survey, you may skip them and move on to the next question. The questionnaire will be floated to the participants at any random days the participants will be greatly available. It will be collected as soon as the survey is done. The information recorded is confidential, your name is not being included on the forms, only a number will identify you, and no one else except the members of the research team or statisticians will have access to your survey.

DurationThe research takes place over 120 days or 4 months in total. During that time, we will float the questionnaire survey at a random day when you are greatly available.

RisksThe research will be completely anonymous and there are no various adverse effects or risks on the part of the participant because it only seeks out perspectives of senior and junior interns in the medical profession on ways which patient safety is addressed.

BenefitsThere will be no direct benefit to you, but your participation is likely to help us find out more about self-reported patient safety competence in Saint Louis University Hospital of the Sacred Heart.

ReimbursementsYou will not be provided any incentive to take part in the research.

ConfidentialityThe research being done in the hospital may draw attention and if you participate you may be asked questions by other people in the institution. We will not be sharing information about you to anyone outside of the research team. The information that we collect from this research project will be kept private. Any information about you will have a number on it instead of yourname. Only the researchers will know what your number is and we will lock that information

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up with a lock and key. It will not be shared with or given to anyone except statisticians and other people only involved in the research.

Sharing the ResultsNothing that you tell us today will be shared with anybody outside the research team, and nothing will be attributed to you by name. The knowledge that we get from this research will be shared with you and the institution before it is made widely available to the public. Each participant will receive a summary of the results. We will publish the results so that other interested people may learn from the research.

Right to Refuse or WithdrawYou do not have to take part in this research if you do not wish to do so, and choosing to participate will not affect youre your internship, internship evaluation or job-related evaluations in any way. You may stop participating in the survey at any time that you wish. We will give you an opportunity at the end of the survey to review your remarks, and you can ask to re-evaluate your answers.

Who to ContactIf you have any questions, you can ask them now or later. If you wish to ask questions later, you may contact any of the following:Awao, Jhozel Kim : 09088135094Balabag, Endoken : 09054278876Cabaling, Reiva Geen : 09771388119Diego, Lilian : 09266689740Gacutan, Glenn Rudolph : 09291807000Nobleza, Chelsea : 09275107687Suguitan, Ryan James : 09162287716Tolero, Arlyn : 09216208165Tuzon, Ferdinand : 09272107878

This proposal has been reviewed and approved by the Saint Louis University Research Ethics Committee (SLU-REC), which is a committee whose task it is to make sure that research participants are protected from harm. If you wish to find about more about the SLU-REC, contact DR. GAUDELIA A. REYES, Chair of the SLU-REC, CP# .

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Part II: Certificate of Consent

I have been invited to participate in research about self-reported patient safety competence.

(This section is mandatory)I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions about it and any questions I have been asked have been answered to my satisfaction. I consent voluntarily to be a participant in this study

Print Name of ParticipantSignature of ParticipantDate Day/month/year

If participant is illiterateA literate witness must sign (if possible, this person should be selected by the partic ipant and should have no connection to the research team). Participants who are illiterate should include their thumb print as well.

I have witnessed the accurate reading of the consent form to the potential participant, and the individual has had the opportunity to ask questions. I confirm that the individual hasgiven consent freely.

Print name of witness Signature of witness Date Day/month/year

Thumb print of participant

Statement by the researcher/person taking consent

I have accurately read out the information sheet to the potential participant, and to the best of my ability made sure that the participant fully understands what s/he is being asked to do in the research project.

I confirm that the participant was given an opportunity to ask questions about the study, and all the questions asked by the participant have been answered correctly and to the best of my ability. I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and voluntarily.

A copy of this ICF has been provided to the participant.Print Name of Researcher/person taking the consent _ Signature of Researcher /person taking the consentDate Day/month/year

Page 4 of 4Appendix B Health Professional Education in Patient Safety Survey (H-PEPSS)

Health Professional Education in Patient Safety Survey

(H-PEPSS)

Questionnaire Instructions:

1. This survey takes approximately 12 minutes to complete

2.This survey seeks the perspectives of students in the health professions on the ways in which patient safety is addressed in health professional education.

3.The survey asks about clinical safety issues (e.g. hand hygiene, transferring patients, medication safety) but also system issues that effect safety (e.g. aspects of the organization, management, or the work environment including policies, resources, communication and other processes)

4.The survey is seeking your perceptions and opinions only. There are no right or wrong answers. Indicate the extent to which you agree or disagree with each question statements. If you are unsure whether you agree or disagree, mark neutral.

5. This survey is completely anonymous. No one will know whether you have chosen to participate or what your individual answers are. Completion of the survey is entirely voluntary, though we do hope you will take this opportunity to help provide the student perspective on this important issue.

Canadian Patient Safety Institute

Institut canadienpour la scurit des patients

Research funded by the Canadian PatientSafety Institute (CPSI) and York UniversityPatient Safety: The pursuit of reduction and mitigation of unsafe acts within the health care system, as well as the use of best practices shown to lead to optimal patient care outcomes.

SECTION 1: Learning about specific patient safety content areas

eee llggr rraa eeuutt rree rroo nnee aagg sstteee llggrr rraa eeuutt rree rroo nnee aagg ssttHere we ask about 7 areas that have to do with keeping patients safe. We would like to know about the extent to which you feel confident about what you learned in each of these areas. We ask you to think about both your classroom and clinical practice setting experiencesand evaluate them separately.

in the classroom in clinical settings Clinical safety: I feel confident in what I learned about 1. safe clinical practice in general

2. hand hygiene

3. infection control

4. safe medication practices

Culture of safety: I feel confident in what I learned about 5. the ways in which health care is complex and has manyvulnerabilities (e.g. workplace design, staffing, technology, human limitations)

6. the importance of having a questioning attitude and speaking up when you see things that may be unsafe

7. the importance of a supportive environment that encourages patients and providers to speak up when they have safety concerns

8. the nature of systems (e.g. aspects of the organization,management, or the work environment including policies, resources, communication and other processes) and systemfailures and their role in adverse events

Working In Teams with Other Health Professionals: I feel confident in what I learned about

9. team dynamics and authority/power differences

10. managing inter-professional conflict

11. debriefing and supporting team members after an adverse event or close call

12. engaging patients as a central participant in the health care team

13. sharing authority, leadership, and decision-making

14. encouraging team members to speak up, question, challenge,advocate and be accountable as appropriate to address safety issues

Communicating Effectively: I feel confident in what I learned about

15. enhancing patient safety through clear and consistent communication with patients

16. enhancing patient safety through effective communication with other health care providers

17. effective verbal and nonverbal communication abilities to prevent adverse events

Managing Safety Risks: I feel confident in what I learned about18. recognizing routine situations and settings in which safety problems may arise

19. identifying and implementing safety solutions

20. anticipating and managing high risk situations

Understanding Human and Environmental Factors: I feel confident in what I learned about21. the role of human factors such as fatigue, competence that effect patient safety22. safe application of health technology

eee llggrr rraa eeuutt rree rroo nnee aagg sstteee llggrr rraa eeuutt rree rroo nnee aagg sstt23. the role of environmental factors such as work flow, ergonomics,resources, that effect patient safety

Recognize, Respond to and Disclose Adverse Events and Close Calls: I feel confident in what I learned about24. recognizing an adverse event or close call

25. reducing harm by addressing immediate risks for patients and others involved

26. disclosing the adverse event to the patient in the classroom in clinical settings

27. participating in timely event analysis, reflective practice and planning in order to prevent recurrence

SECTION 2: How broader patient safety issues are addressed in health professional education

strongly disagree

disagree neutral /unsure

agree strongly agree

28. As a student, the scope of what was safe for me to do in the practice setting was very clear to me

29. There is consistency in how patient safety issues were dealt with by different preceptors inthe clinical setting

30. I had sufficient opportunity to learn and interact with members of interdisciplinary teams

31.I gained a solid understanding that reporting adverse events and close calls can lead t change and can reduce reoccurrence of eventso

32.Patient safety was well integrated into the overall program

33.Clinical aspects of patient safety (e.g. hand hygiene, transferring patients, medication safety] were well covered in our program

34.System aspects of patient safety were well covered in our program (e.g. aspects of the organization, management, or the work environment including policies, resources,communication and other processes)

SECTION 3: Comfort speaking up about patient safety

35. In clinical settings,discussion around adverse events focuses mainly on system-related issues, rather than focusing on the individual(s) most responsible for the event36. In clinical settings, reporting a patient safety problem will result in negative repercussions for the person reporting it

stronglydisagreeneutral /agreestronglydisagreeunsureagree

37. If I see someone engaging in unsafe care practice in the clinical setting,, I feel safe to approach them

SECTION 4: Demographic information

39. Health professional programRN NursingLPN/RPN NursingPharmacyOTPTMedicine Other: 40. Program stage

I am currently in year of a year program

I have recently completed a year program41. Previous degrees / diplomas (check all that apply)High school diploma Community college diplomaBachelors degreeMasters degreePhD42. Age group:

5043. Gender:

FemaleMale44. Did you have training in a clinical setting prior to this program?YesNo