PARTICIPANT INFORMATION AND CONSENT FORM
Title: Evaluation of Cardiovascular Assessment and Medication
Management by Pharmacists at the UBC Site (CAMMPUS-EVAL)
Principal Investigator: Peter J. Zed, BSc., PharmD,
Associate Professor and Associate Dean Practice Innovation,
Faculty of Pharmaceutical Sciences, University of British Columbia,
2405 Wesbrook Mall, Vancouver, BC, V6T 1Z3
Phone: 604-827-1078, assistant: 604-827-1089
Co-Investigators (all at Faculty of Pharmaceutical Sciences, University of British
Columbia): Mary De Vera, PhD, Assistant Professor
Peter S Loewen, BSc., PharmD, Assistant Professor
Larry Lynd, PhD, Professor
Barbara Gobis, BSc. (Pharm), Director of Pharmacists Clinic
1. Invitation
You are invited to participate in a study to explore the impact of a cardiovascular
health service provided by pharmacists at the UBC Pharmacists Clinic. We are
inviting UBC staff and faculty who are part of the UBC extended health plan
(group no: 25205) and who have chosen to receive the comprehensive
medication management (CMM) service offered by the clinic to participate in this
study, which involves an evaluation of that service.
2. Your Participation is voluntary
Your participation is voluntary. It is up to you to decide whether or not to take part
in this study. Before you decide, it is important for you to understand what the
study involves. Please take your time to read the following information carefully.
3. Who is conducting this study?
Dr. Peter Zed and the co-investigators listed above at the Faculty of
Pharmaceutical Sciences at UBC are conducting this study. They form the
CAMMPUS-EVAL study team.
4. Background
The Pharmacists Clinic at the Faculty of Pharmaceutical Sciences at UBC is a
licensed, pharmacist-led patient care site on the UBC Vancouver campus
dedicated to optimizing health and drug therapy outcomes for people. The
pharmacists who provide care there are medication therapy experts. The
Pharmacists Clinic is also a teaching and research site for new service models,
healthcare processes and pharmacy practices.
5.What is the purpose of this study?
The purpose of this study is to evaluate whether pharmacist-led comprehensive
medication management (CMM) service can help to reduce the cardiovascular
risk of participating staff and faculty at the UBC Vancouver Campus. We are also
interested if this service can improve the wellbeing of participants.
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6.Who can participate in this study?
You can take part in this study if
 You are enrolled as a primary member to UBC extended health benefit
plan (group no: 25205)
 You work at the UBC Vancouver location(s)
 You have, or you suspect that you have a health condition such as high
blood pressure, elevated blood lipids, a habit of smoking tobacco, are
overweight, or have been diagnosed with diabetes
OR
Your cardiovascular risk is higher than 10% as previously assessed in the
participant screening (see below)
 You have chosen to receive the CMM service offered by the Pharmacists
Clinic
7. Who should not participate in this study?
You should not take part in this study if:
 You are not able to visit the Pharmacist Clinic at UBC up to five times
(because, for example, you will be out of the country for long periods,
ending your time at UBC, or otherwise out of reach for several months) in
the coming 12 months.
 You participated in the 2014 UBC Traveling Health Fair, and have been or
are already receiving care at the Pharmacists Clinic for cardiovascular
reasons
 You are under 18 years of age.
8. What does this study involve?
Part 1: Participant Screening
This screening of potential CAMMPUS-EVAL participants involves a visit to
Pharmacists Clinic to find out your level of cardiovascular risk. The visit takes
about 20 minutes of your time.
During the visit, pharmacist will interview you (about your age, gender, tobacco
smoking habits), measure your blood pressure, and measure your blood
cholesterol and glucose. This information will be used to determine your
Framingham Risk Score. The Framingham Risk Score estimates the likelihood
that a person will experience a cardiovascular event (for example, heart attack or
stroke) within the next 10 years.
For those who have diabetes, we will use a modified risk assessment tool
especially for diabetics, called UKPDS. It estimates the likelihood that a person
with diabetes will experience a cardiovascular event within the next 10 years.
We will tell you the results of all of these measurements, your Framingham Risk
Score, and your estimated 10-year risk of cardiovascular disease. You can use
the information from this screening to make health-related decisions to lower
your risk and improve your health.
If your risk is lower than 10%, we will direct you to health care resources to
maintain your heart health or address other health issues if you are interested.
Unfortunately, we cannot invite you to participate in the CAMMPUS-EVAL study.
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If your risk is higher than 10%:
 You will be offered “comprehensive medication management” (CMM)
service from the Pharmacists Clinic. This CMM is the usual standard of
care that is offered by the Pharmacists Clinic to anyone at risk of
cardiovascular disease and has nothing to do with this research study.

You will also be invited to participate in the CAMMPUS-EVAL study to
evaluate the impact the CMM service has on your health. You will be
given a CAMMPUS-EVAL study participant information and consent form
to review at your own pace.
Part 2: Service Evaluation Study
If, based on Part 1, you are eligible for and choose to receive the CMM service (a
separate decision you make that is not part of this research), to help us evaluate
the CMM service you are receiving, we will ask you to fill out 3 questionnaires at
each clinic visit: One about how you take your medication (if you take any),
another about your quality of life, and a third about the ways your health impacts
your daily activities.
You do not have to answer any questions you find uncomfortable or do not want
to answer. You will spend up to 30 minutes filling questionnaires for the first visit,
and about 10 minutes answering questionnaires at each follow-up visit. In total,
this study will take about 1 – 1.5 hours of your time during the 12-month study
period. At one year after you started participating this study, you will be asked to
fill out the questionnaires one more time. That visit will end your participation in
the evaluation.
We are also asking for your consent to access your PharmaNet, a Ministry of
Health BC -administered database, for purpose of this research. This profile
contains information about drugs prescribed and dispensed to you. To do this,
we will request a link via Population Data BC (PopDataBC) to PharmaNet. This
linking is done in a way that protects your confidentiality.
Once you have signed this informed consent form, we will collect information
about you (name, age, gender, and medical conditions), and details about your
visit(s) to the clinic (your Framingham Risk Score (or UKPDS score if you have
diabetes) calculated at each visit, your medication – if any, how you take your
medication – if any). This information will be used for the purposes of this
research.
We will be collecting this information while you receive the service for up to 12
months, or until you withdraw your consent, whichever comes first. This
information will be stored in a study database at the Pharmacists Clinic.
9. A. What are the potential benefits for participation in this study?
There are no direct benefits to you for participation in this evaluation of
CAMMPUS service.
9.B. What are the potential harms for participation in this study?
There is a very small risk that your research data may be linked to your health
records that may enable you to be identified. However, your research data will be
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secured in the same manner as our clinical records and access is limited to the
study investigators only. Both the Pharmacists Clinic and UBC must follow the
rules of the BC Freedom of Information and Protection of Privacy Act.
10. What happens if I decide to withdraw my consent to participate?
You may withdraw from this study at any time without giving a reason. If you
choose to enter the study and then decide to withdraw at a later time, all data
collected about you during your enrolment in the study will be retained for
analysis. You may ask us to destroy all that data. Your withdrawal does not
change in any way the care you receive at the Pharmacists Clinic or any other
benefits you receive.
11. How will my participation in this study be kept confidential?
Your confidentiality will be respected. However, research records and health or
other source records identifying you may be inspected in the presence of the
Investigator or his designate and by representatives of UBC Clinical Research
Ethics Board for the purpose of monitoring the evaluation. No information or
records that disclose your identity will be published without your consent, nor will
any information or records that disclose your identity be removed or released
without your consent unless required by law.
The staff at Pharmacist Clinic will assign a unique study code for your
information. This number will not include any personal information that could
identify you (e.g., it will not include your Personal Health Number, SIN, or your
initials, etc.). Only this number will be used on any research-related information
collected about you during the course of this study, so that your identity will be
kept confidential. Information that contains your identity will remain only with the
Principal Investigator and/or designate. The list that matches your name to the
unique study number that is used on your research-related information will not be
removed or released without your consent unless required by law. No information
that can identify you will be shared with anyone outside of the Pharmacists Clinic
care team, with the exception when for linkage purposes the personnel at the
PopData BC will see your name and PHN. PopData BC will not have access to
any study data. PopData BC is a multi-university organization dedicated to data
access, protection and privacy of research data. PopData BC will not use your
information in any way other than as authorized by this consent form.
The evaluation team will only see coded information about you. Your information
will not be sold.
Study data will be stored at the Pharmacists Clinic in password-protected and
encrypted computer files for 5 years after the study has been presented or
published, as per UBC policy 85 “Scholarly Integrity”. All study data and any
paper records will be destroyed at that point following established procedures
and guidelines.
Your right to privacy is legally protected by federal and provincial laws that
require us to ensure that your privacy is respected. You also have the legal right
to access the information about you that has been collected in the study and, if
need be, an opportunity to correct any errors in this information. Further details
about these laws are available on request.
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The study results will be shared with UBC Human Resources in a way that
cannot identify any individuals. In other words, only summary data will be shared.
UBC wants to know whether the CMM service can help its employees’ health and
wellbeing.
12. What happens if something goes wrong?
By signing this form, you do not give up any of your legal rights and you do not
release the study doctor, participating institutions, or anyone else from their legal
and professional duties.
13. Will I get paid for participating in this study? Will it cost me anything?
You will not be reimbursed for participating in this study. There will be no costs to
you for participating and receiving the services of the pharmacist, either. Your
UBC extended health plan will be paying for all of the costs of the CMM service
you receive from the Pharmacists Clinic while you are a participant in the
CAMMPUS-EVAL study, as well as for the screening procedures.
14. Who do I contact if I have questions about the study during my
participation?
If you have any questions or desire further information about this study before or
during participation, you can contact the Pharmacist Clinic (604-827-2584) or Dr.
Peter Zed (604-827-1078).
15. Who do I contact if I have any questions or concerns about my rights
and / or experiences as a participant during the study?
If you have any concerns or complaints about your rights as a participant or your
experiences in this study, please contact the Research Participant Complaint
Line in the University of British Columbia Office of Research Ethics by e-mail at
RSIL@ors.ubc.ca or by phone at 604-822-8598 (Toll Free: 1-877-822-8598).
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Evaluation of Cardiovascular Assessment and Medication Management by
Pharmacists at the UBC Site (CAMMPUS-EVAL)
PARTICIPANT CONSENT
My signature on this consent form signifies that:
 I consent to receive a cardiovascular risk screening to determine my
eligibility to participate in a study to explore the impact of Comprehensive
Medication Management (CMM) service at the UBC Pharmacists Clinic on
my cardiovascular risk and heart health.
 I understand that if the screening result shows that my cardiovascular risk
is lower than 10%, I will not be offered Comprehensive Medication
Management (CMM) service or add on procedures as part of CAMMPUSEVAL study. I will be guided to other health care resources to maintain
my heart health or address other health issues if I am interested.
 I understand that if my cardiovascular risk is higher than 10%, I will be
invited to receive standard Comprehensive Medication Management
(CMM) service from the Pharmacists Clinic as well as add-on procedures
related to the CAMMPUS-EVAL study. After receiving more information
about CAMMPUS-EVAL, I will decide about my participation in it.
 I consent to provide information about my experience receiving
Comprehensive Medication Management (CMM) service at the
Pharmacists Clinic, if I choose to receive that service.
 I have read and understood the Participant information and consent form.
 I have had the opportunity to ask questions and have had satisfactory
responses to my questions.
 I understand that all of the information collected about me will be kept
confidential and that the results will only be used for the stated objectives
of the study.
 I understand that my participation in this study is voluntary and that I am
completely free to refuse to participate or to withdraw from this study at
any time without changing in any way the quality of care that I receive.
 I understand that if I choose to withdraw from this study all data collected
about me during my enrollment in the study will be retained for analysis.
 I consent for my PHN to be used for reviewing and linking my PharmaNet
profile for research purposes of this study.
 I consent for my personal information to be used in coded form for the
study purposes.
 I understand that I am not waiving any of my legal rights as a result of
signing this consent form.
 I will receive a signed and dated copy of this consent form for my own
records.
________________________
Name of Participant
_________________________
Signature of Participant
__________
Date
________________________
Person obtaining consent
_________________________
Signature
__________
Date
_________________________
Study Role / Position
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