Consent Form- Improving The Uptake of TAVR In Ontario

May 20, 2020. Version 5

REB NO: 00038830

Study Title: Improving The Uptake of TAVR In Ontario

Student Principal Investigator:

Abimbola K. Saka, M.D, M.B.A, MHSc Translational Research Program, Faculty of Medicine, University
of Toronto.

Translational Research Program Advisor:

Name: Joseph Ferenbok Ph.D. Director of the Translational Research Program, Faculty of Medicine,
University of Toronto

Advisory Committee Team:

Name: Michael Farkouh M.D. Department of Medicine. Vice Chair, Research, Department of Medicine,
University of Toronto and the Director, Heart & Stroke Richard Lewar Centre of Excellence, University
of Toronto.

Name: Harindra C. Winjeysundera M.D. Associate Professor, Department of Medicine, Division of

Cardiology, University of Toronto. Investigator, Toronto Health Economics and Technology Assessment
Collaborative, University of Toronto. Senior Adjunct Scientist, Institute for Clinical Evaluative Sciences,
University of Toronto

Name: Neil Fam M.D. Director of the Coronary Care Unit. Clinician Teacher in the Division of
Cardiology and the Director of the University of Toronto Interventional Cardiology Fellows Course

Name: Laura Hartman Ph.D. A registered Occupational Therapist and a Researcher at Holland Bloorview
Kids Rehabilitation Hospital Research Institute.

Name: Maral Ouzounian M.D. Cardiac and Aortic surgeon and Surgeon Scientist at the Peter Munk
Cardiac Centre, and Associate Professor of Surgery at the University of Toronto.

Research Contact:
Abimbola K. Saka, MHSc Translational Research Program, Faculty of Medicine, University of Toronto.

Study Site: University of Toronto

Conflict of Interest: None

Introduction
We want to invite you to take part in our research study. This consent form describes the research study
and what it means to participate. This consent form may have words that you do not understand. Please
ask the student principal investigator to explain anything that you do not understand. All participation is
voluntary, and you are not under any obligation to participate.

Participant Consent Form

REB NO: 00038830

Why am I being asked to participate?
You are invited to participate in this study because you have identified as a decision-maker in the
treatment of severe aortic stenosis.

Why is this study being done?

Current guidelines recommend transcatheter aortic valve replacement ( TAVR) over surgical aortic valve
replacement (SAVR) for patients with high-risk aortic stenosis (Nishimura 2017). However, there is an
observed asymmetry in the proportion of patients undergoing TAVR across Ontario hospitals. Nationally,
SAVR is more performed across Canada despite having 28 TAVR centers across the provinces, except for
two provinces (Saskatchewan and Newfoundland) (Asgar et al. 2018). This study is being done to
understand how to improve guideline uptake.
The study hopes to:
1. Understand the principle reasons why SAVR is chosen over TAVR; and
2. To develop an evidence-based intervention to promote TAVR as the preferred alternative in
patients deemed intermediate to high risk for surgery.
If you chose to participate in this survey, you would be asked specific questions regarding the treatment of
aortic stenosis. Your responses will enable us to identify key factors influencing the decisions to perform
SAVR and TAVR.
Your responses will help guide the intervention to improve TAVR adoption in Ontario. All reasonable
steps will be taken to ensure confidentiality, and all data will be stored in a password protected electronic
format.

How many participants will be in this study?

385 participants are expected to participate in this study.

What will happen if I join this study?

If you chose to participate in this survey, we will ask you specific questions regarding the treatment of
aortic stenosis. Your responses will enable us to identify the characteristics of the decision-makers that
perform SAVR and TAVR, and the factors influencing these decisions.
Your responses will also guide our intervention to improve the adoption of TAVR in Ontario. We will do
our best to keep your information confidential. All data is stored in a password protected electronic
format.

Methods: The research method has three phases; an online survey, a co-design session to explore the
decision-making behind performing either SAVR or TAVR therapies- utilizing the implementation for
change model from the insights obtained from phase one, and a pilot phase to test the strategy
developed to improve the evidence-based update of TAVR

Phase one (Survey) of the project will employ the use of an electronic survey to understand the
characteristics of the decision-makers of both SAVR and TAVR therapies and recruit interested
participants for phase two of the research. The online survey will inquire about the characteristics of the
decision-makers, your knowledge of the procedure, your behaviors regarding the use of TAVR and
SAVR, and perceived barriers to TAVR uptake. At the end of the online survey, we will ask participants
if they would be willing to participate in a 2hrs 30 minutes co-design session to develop an intervention to

Participant Consent Form

20, May, 2020
REB NO: 00038830
 improve the uptake of TAVR. If so, they will be prompted to provide their email address. At one
month, the survey responses will be gathered and analyzed by the research team using the descriptive
analysis

Phase two (Co-design session) will involve a virtual co-design session with a group of respondents.
Using the implementation for change model, we will develop an intervention to improve the uptake of
TAVR. The co-design session will mitigate the “why” to the responses gathered from the survey. The
implementation for change model highlights the different stages of change management and its impact at
various levels of an organization.
We will recruit ten respondents who meet the predefined criteria for the co-design session. The
predefined criterion for selection is that participants must have an active role in the decision making of
TAVR and must have completed the online survey in phase one of the research. An invitation with the
details and structure of the virtual co-design session will be provided to participants via email. This
session will be facilitated by the student PI- Abi, and audio-recorded for accuracy. The audio recording
will be done using the student PI’s desktop. We will destroy all recordings after analysis.
We will ask participants to type In their responses electronically. All responses will be gathered and
stored electronically on SharePoint and audio recordings will be permanently deleted after analysis.
SharePoint is a secure way of transferring data. The data stored on SharePoint will be kept for up to 1
year and securely removed/deleted after the research is complete and in compliance with the University
of Toronto's regulations. The information stored on SharePoint will be password protected, and only
the student PI (Abi) will have access.

The co-design session will be a two and a half-hour session broken into: an introduction, discussion of the
barriers and facilitators of TAVR and SAVR, Idea gathering, and synthesis and mapping of each concept
to the identified barriers to developing a testable intervention. At the end of the co-design session, we will
then test the strategy developed amongst a few stakeholders with the intention of broader implementation.

Phase three (Pilot test with survey) will involve a survey of five decision-makers to identify if the
strategy works and if this will change or impact their decision making. The survey will be administered in
an electronic format through survey monkey. A participant must be a decision-maker and must have
participated in phase one of the research. Two follow-up emails will be sent at a one-week interval to
remind participants to complete the survey. The survey will close after three weeks of the initial email.
At three weeks, the survey responses will be gathered and analyzed by the research team using
standardized techniques.

Data collection and Analysis:

All identifiable information will be kept strictly confidential. Names, ids, email addresses, profession,
specializations, demographics will not be shared unless participants give additional consent. Data
collected will be assigned ID's that will only be accessible to the research team. The anonymity of
participants will be protected when reporting results obtained from this study (i.e., demographic variables
will be summarized, and no individual data will be available to the University of Toronto). The co-design
session will be audio-recorded for accuracy. We will destroy the audio recordings after analysis. The
anonymity of participants will be protected when reporting results collected from this study (i.e.,
demographic variables will be summarized, and no individual data will be available to the University of
Toronto). All electronic responses will be stored on SharePoint and all physical forms will be stored in a
secured safe. Data analysis will be done by the research team using standardized techniques. The survey

Participant Consent Form

20, May, 2020
REB NO: 00038830
 data will not include identifiable information such as; name, age, email addresses, and sex.
Demographic details summarized will consist of the year of practice, institutional practice type,
institutional setting, and specialty. Only participants with an expressed interest in the co-design
session will be asked to provide their email addresses. Emails will be collected solely to contact
interested participants and deleted after the co-design session.

Impact and Significance: The outcome of this project will contribute to the understanding of the
dissemination, implementation, and adoption of new standards of care; provide insights into the
development and implementation of possible interventions to expedite the adoption of new practices. It
will improve the rate of TAVR over SAVR in Ontario- to lower the risk of complications for high-risk
patients with severe aortic stenosis.

The co-design session will be audio recorded. The audio recording will be transcribed and will be
analyzed by the research team. Abimbola Saka and Dr. Laura Hartman will do the transcription. We will
not include your name and identifiable information during the recording, except your voice. After
transcribing the audio recording and checking it for accuracy, we will destroy all recordings.

You will be asked to:

1. Read and sign the consent form
2. Asked to complete a survey to help us identify the characteristics of the decision makers for
TAVR or SAVR
3. Asked to participate in the co-creation/ideation session to develop a testable intervention to
improve TAVR uptake

Audio Recording:
There is a potential risk of loss of your confidentiality because even though your name will not be part of the
audio recording or the transcription, your voice may still be identifiable as your voice. If anyone mentions
identifiers (e.g., your name, location), during the recording, they will be removed from the transcript.

Co-design Session:
Although we will take every precaution to maintain the confidentiality of the data, the nature of co-design
session prevents the research team from guaranteeing confidentiality. Some members may repeat things
said in the co-design session. The research team will ask participants to respect the privacy of fellow
participants and not repeat what is said in the co-design session to others.

Harm
We don’t know of any risks or harms associated with participating in this study.

The inconvenience of time:

Time may be inconvenient. In addition to completing the online survey, the co-design session will take
2hours 30 minutes.

Confidentiality risk
Despite protections being in place, there is a risk of unintentional release of information.

Benefits
Participant Consent Form
20, May, 2020
REB NO: 00038830
 We hope that this project contributes to the understanding of the dissemination, implementation,
and adoption of new standards of care; provides insights into the development and implementation of
possible interventions to expedite the adoption of new practices and improve the rate of TAVR over
SAVR in Ontario. To lower the risk of complications for high-risk patients with severe aortic stenosis.

What are the optional part(s) to this research study?

We may decide to use parts of the transcription without your name and voice in presentations or
publications in the format of quotations. You have the option to refuse. Please initial next to your
preference:
Options Initials

I allow the use of parts of my de-identified transcription in

presentations and publications.
I do not allow the use of parts of my de-identified transcription in
presentations and publications.

Can I choose to leave the study?

It is your choice to take part in this study, and participation is voluntary. You can change your mind at any time
during the research study. The study team may ask why you are withdrawing for reporting purposes, but you do
not need to give a reason to withdraw from the study if you do not want to. If you decide to leave the study, you
can contact the student Principal Investigator or a member of the study team to let them know. If withdrawal
occurs after the co-design sessions, any data collected obtained during the study will remain as part of the study
as removal of the data may skew the outcome of the study.

Will I be paid and reimbursed if I join this study?

We will give each participant in the co-design session a $25 gift card as an honorarium for their time.

How will my privacy be protected?

We will respect your privacy. No information about you will be given to anyone or be published without your
permission unless the law requires us to do this. The University of Toronto is also committed to respecting your
privacy.

If you decide to participate in this study, the study will collect only the information needed for this study. The
research team will also collect some personal information about you (name, phone number, email, and specialty)
to contact you. This personal information will not be shared outside of the research team.

To protect your identity, the information that will be on your data will be limited to assigned identification
numbers. The data collected will be stored in a secure excel file and stored in SharePoint- a secure way of
transferring data. The data stored on SharePoint will be kept for up to 1 year and securely removed/deleted after
the research is complete and in compliance with the University of Toronto's regulations. The information
stored on SharePoint will be password protected, and only the student PI (Abi) will have access. Despite
protections being in place, there is a risk of unintentional release of information. Physical forms will be kept in a
file and stored in a secure safe. Even though the risk of identifying you from the study data is minimal, it can
never be eliminated.

How will I be informed about new information?

Participant Consent Form
20, May, 2020
REB NO: 00038830
 We may learn new information during the study that you may need to know. We may also learn about
things that might make you want to stop participating in the study. If this happens, We will notify you of any new
information promptly.

What are my rights when participating in a research study?

You have the right to receive all the information that could help you decide to participate in this study. Also, you
have the right to ask questions about this study at any time and to have them answered to your satisfaction. Your
rights to privacy are legally protected by federal and provincial laws that require safeguards to ensure that your
privacy is respected.

Will I receive study results?

We will share the results of this research through journal publications, academic conferences, any other means of
disseminating information. When the results of this study are shared, your identity will not be disclosed. You
have the right to be informed of the results of this study once the entire research is complete.
If you would like us to inform you of the results of this study, please contact the student principal investigator.

We will only provide you with the overall study results (aggregate results from all participants). This means you
will not know the results as they relate to you specifically.

Who can I call if I have questions about the study?

If you have any questions during your participation in this research study, you can contact the Student Principal
Investigator, Abimbola K. Saka (Abi) at 647-388-2993, or the research team members listed at the beginning of
this consent form.

Research Ethics Board Contact Information

This study will be reviewed by the University of Toronto Research Ethics Board (REB). The REB is a group of
people who oversee the ethical conduct of research studies. The REB is not part of the study team. If you have
any questions regarding your rights as a research participant, you may contact the Research Ethics Office at
416946-5606 during business hours.

Consent to Participate in a Research Study

Study Title: Improving The Uptake of TAVR In Ontario

You are invited to participate in this study because you have identified as a decision-maker in the treatment of
severe aortic stenosis.
This study is being done because, while the current guidelines are clear on the benefits of TAVR over SAVR in
intermediate to high-risk inoperable patients with severe aortic stenosis, there is an observed asymmetry in the
proportion of patients undergoing TAVR across Ontario hospitals. Nationally, SAVR is more performed across
Canada despite having 28 TAVR centers across the provinces, except for two provinces (Saskatchewan and
Newfoundland) (Asgar et al. 2018).
we hope to:
1. Understand the principle reasons why SAVR is chosen over TAVR; and
2. To develop an evidence-based intervention to promote TAVR as the preferred alternative in patients
deemed intermediate to high risk for surgery.

Participant Consent Form

20, May, 2020
REB NO: 00038830
 If you chose to participate in this survey, we would ask you specific questions regarding the treatment of
aortic stenosis. Your responses will enable us to identify the characteristics of the decision-makers that perform
SAVR and TAVR, and the factors influencing these decisions.
Your responses will also guide our intervention to improve the uptake of TAVR in Ontario. All reasonable steps
will be taken to ensure confidentiality, and all data will be stored in a password protected electronic format. All
data is stored in a password protected electronic format.
Any contact information provided will be collected on a secure excel file and stored in the University of Toronto
SharePoint. SharePoint Online is a cloud-based shared service that is part of the Office 365 suite, and it is
operated and managed by the Information Technology Services (EASI). The data stored on SharePoint will be
kept for up to 1 year and securely removed/deleted after the research is complete and in compliance with the
University of Toronto's regulations. The information stored on SharePoint will be password protected, and
only the student PI (Abi) will have access. If you have any questions about the research study, please contact
Abi at abimbola.saka@utoronto.ca. This research has been reviewed according to the University of Toronto
REB procedures for research involving human subjects.
Electronic Consent Survey: By clicking on the "agree" button below indicates that:
1. you have read the above information
2. you voluntarily agree to participate
If you do not wish to participate in the research study, please decline participation by clicking on the "disagree"
button.
 Agree  Disagree

Consent to participate In the study: Do you wish to participate in this study?

 Agree  Disagree

Printed Name of Participant Participant signature & date

(DD/MMM/YYYY)

Printed Name of the person who Role of person Signature & date obtained
is obtaining consent (DD/MMM/YYYY)

Student Principal Investigator Signature

Investigator Signature Printed name Date (DD/MMM/YY)

My signature above signifies that the study has been reviewed with the study participant by me.

Participant Consent Form

20, May, 2020
REB NO: 00038830