Saint Louis University

School of Medicine A.
Bonifacio Street
Baguio City, Philippines 2600
(063) 74 444 8246 to 48

In partial fulfilment for the requirements of

METHODS OF RESEARCH II

RESEARCH PROTOCOL

Submitted To:
DR. JOHN ANTHONY DOMANTAY

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

19 December 2015

I.

II.

General Information

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

Principal Investigator: Cabaling, Reiva Geen

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 of
10%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 1 of 6

integrating 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 internetbased 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-PEPSS
dimensions
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. Age
b. Gender
c. Year level
d. 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 selfreported 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 Management
The 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 Analysis
To 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 the
Ethics 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

"World Alliance for Patient Safety". Organization Web Site. World Health
Organization. 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
1.

3. Correction to Advancing Measurement of Patient Safety Culture . Health Services

Research. 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-2014003142
5. 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/S14748231(08)07003-1
6. 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-2012-001308
7. Thain S, Ang S, Ti L. Medical students' preferred style of learning patient safety.
BMJ Quality & Safety. 2011; 20(2):201-201.
XV. Appendix

PROTOCOL 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
safety
competence 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 UniversityHospital of the Sacred Heart and who we are inviting to participate in the research titled Selfreported Patient Safety Competence among Senior and Junior Medical Interns of Saint Louis
University- Hospital of the Sacred Heart
Name of Principle Investigator: Reiva Geen Cabaling
Name 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 Form
Part I: Information Sheet
Introduction
We 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 research
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. 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 Intervention
This research will involve your participation in a questionnaire survey that will take about 12
minutes to complete.
Participant Selection
You 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
Page 1 of 4

safety competence.
Voluntary Participation
Your 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.
Procedures
A. 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.
Duration
The 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.
Risks
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.
Benefits
There 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.
Reimbursements
You will not be provided any incentive to take part in the research.
Confidentiality
The 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 your
name. Only the researchers will know what your number is and we will lock that information
Page 2 of 4

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 Results
Nothing 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 Withdraw
You 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 Contact
If 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 : 09088135094
Balabag, Endoken : 09054278876
Cabaling, Reiva Geen : 09771388119
Diego, Lilian : 09266689740
Gacutan, Glenn Rudolph : 09291807000
Nobleza, Chelsea : 09275107687
Suguitan, Ryan James : 09162287716
Tolero, Arlyn : 09216208165
Tuzon, 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#
.

Page 3 of 4

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 Participant

Signature of Participant
Date
Day/month/year
If participant is illiterate
A 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 has
given 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 consent
Date
Day/month/year

Page 4 of 4

Appendix 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
canadien
pour la scurit
des patients

Research funded by the Canadian Patient

Safety Institute (CPSI) and York University

Patient 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

Here 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.
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eee ll
ggr rraa ee
oott eerree aagg
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in the classroom
Clinical safety: I feel confident in what I learned about
1.
2.
3.
4.

safe clinical practice in general

hand hygiene
infection control
safe medication practices

in clinical settings

Culture of safety: I feel confident in what I learned about

5.
6.
7.
8.

the ways in which health care is complex and has many

vulnerabilities (e.g. workplace design, staffing, technology, human
limitations)
the importance of having a questioning attitude and speaking up
when you see things that may be unsafe
the importance of a supportive environment that encourages
patients and providers to speak up when they have safety concerns
the nature of systems (e.g. aspects of the organization,
management, or the work environment including policies,
resources, communication and other processes) and system
failures 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 about

18. 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 about
21. the role of human factors such as fatigue, competence that effect
patient safety
22. safe application of health technology

eee ll
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oott eerree aagg
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sstt nn

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in the classroom

in clinical settings

23. 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 about
24. recognizing an adverse event or close call

25. reducing harm by addressing immediate risks for patients and

others involved
theinadverse
eventanalysis,
to the patient
26.
27. disclosing
participating
timely event
reflective practice and
planning in order to prevent recurrence

SECTION 2: How broader patient safety issues are addressed in health professional education
strongly disagree neutral /
disagree
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 in
the 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 to
change and can reduce reoccurrence of events
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)

agree

strongly
agree

SECTION 3: Comfort speaking up about patient safety

strongly disagree neutral /
disagree
unsure

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 event
36. In clinical settings, reporting a patient safety problem will result in negative repercussions
for the person reporting it
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
program

40. Program stage

RN Nursing
LPN/RPN Nursing
Pharmacy
OT
PT
Medicine
Other:

I am currently in
year
of a
year program
I have recently
completed a
year program

41. Previous degrees /

diplomas (check all that
apply)
igh school diploma
H
Community college
diploma
Bachelors degree
Masters degree
PhD

42. Age group: 43. Gender:

<21
21-25
26-30
31-40
41-50
>50

Female
Male

44. Did you have training

in a clinical setting prior
to this program?
es
Y
No