eCarePlan Information Sheet - FOCUS GROUPS

Information Sheet and Authorization
IRB# 25590

TITLE: Implementation of an Electronic Care Plan for People with Multiple Chronic Conditions (eCarePlan v2)
PRINCIPAL INVESTIGATOR:

David Dorr, MD, MS

(503) 418-2387

CO-INVESTIGATORS:

Anthony Cheng, MD
Emily Morgan, MD

(503) 494-8573
(503) 494-8562

WHO IS PAYING FOR THE STUDY?: Agency for Healthcare Research and Quality (AHRQ)
WHY IS THIS STUDY BEING DONE?
You have been invited to be in this research study because you are a clinician who treats individuals
experiencing multiple chronic health conditions. The purpose of this study is to support the
development and testing of a care planner application that is designed to support care coordination,
communication, and collaboration for care team members across all settings, including the home.
WHAT PROCEDURES ARE INVOLVED IN THIS STUDY?:
We are asking you to join up to three focus groups that will occur over six months (November 2023 –
April 2024). During those focus groups, you will be shown an application that is currently under
development, and will be asked for your impressions. You will, also, be asked general questions about
your approach to care planning, and how an application of the type that under development might best
meet your and your patients’ care planning needs. The focus groups will be audio recorded.
WHAT RISKS CAN I EXPECT FROM TAKING PART IN THIS STUDY?
The only risks you can expect from taking part is the use of your time, and possible loss of security of
your identifiable voice on the audio recording (though, we will make every attempt to limit the number
of people who hear the audio recording, and will de-identify your comments before they are shared for
the purpose of analysis). One or more members of the organization working to develop the app may
attend the focus groups and hear your comments, directly, in a way that is identifiable. No one else,
outside of the research team at OHSU, will be able to attribute your comments to you.
WHAT ARE THE BENEFITS OF TAKING PART IN THIS STUDY?
You will not directly benefit from being in this study. However, by participating, you may help us learn
how to benefit patients in the future.
WHAT ARE THE ALTERNATIVES TO TAKING PART IN THIS STUDY?
You may freely choose not to participate in this study.
WILL I RECEIVE RESULTS FROM THIS STUDY?
You will not receive results from this study.
If you are interested in staying informed about the progress being made on the development of the
application, and continuing to contribute to the development process, we may ask for your permission
to contact you again in the future.
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WHO WILL SEE MY PERSONAL INFORMATION?
Any information you offer during your participation in the focus groups will be seen/heard by the OHSU
research team. Once the focus groups are conducted, and the audio recordings are processed, your
comments will be de-identified for the purpose of analysis.
We may have to release this information to others for example, if the study is audited. However, we
would try to do so without information that could identify you. This release could be to the Institutional
Review Board (ethics review committee) at OHSU, the funder of the study, or the Office of Human
Research Protection (agencies that oversee research). If your information goes outside of OHSU, it might
not be protected under federal law from being used or further shared.
If you decide at any point that you no longer want to participate, you can request this by contacting:
Gina DeNoble, MS
Research Project Coordinator
Department of Medical Informatics and Clinical Epidemiology
Oregon Health & Sciences University
[email protected]
Your request will be effective as of the date we receive it. However, information collected before your
request is received may continue to be used and disclosed to the extent that it already has been based
on your authorization.
WILL ANY OF MY INFORMATION FROM THIS STUDY BE USED FOR COMMERCIAL PROFIT?
Information, including any photographs, videotapes, or audiotapes, about you or obtained from you in
this research may be used for commercial purposes, such as making a discovery that could, in the future,
be patented or licensed to a company, which could result in a possible financial benefit to that company,
OHSU, and its researchers. There are no plans to pay you if this happens. You will not have any property
rights or ownership or financial interest in or arising from products or data that may result from your
participation in this study. Further, you will have no responsibility or liability for any use that may be
made of your samples or information.
WHAT ARE THE COSTS OF TAKING PART IN THIS STUDY?:
It will not cost you anything to participate in this study. You will receive $150 for participating. It will be
delivered in the form of an electronic gift card.
WHERE CAN I GET MORE INFORMATION?:
This research is being overseen by an Institutional Review Board (“IRB”). You may talk to the IRB at (503)
494-7887 or [email protected] if:
• Your questions, concerns, or complaints are not being answered by the research team
• You want to talk to someone besides the research team
• You have questions about your rights as a research subject
• You want to get more information or provide input about this research
You may also submit a report to the OHSU Integrity Hotline online at
https://secure.ethicspoint.com/domain/media/en/gui/18915/index.html or by calling toll-free (877)
733-8313 (anonymous and available 24 hours a day, 7 days a week).
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DO I HAVE TO TAKE PART IN THIS STUDY?
You do not have to join this or any research study. If you do join, and later change your mind, you may
quit at any time. If you refuse to join, or you withdraw early from the study, there will be no penalty or
loss of any benefits to which you are otherwise entitled.
WHAT IF I AM AN OHSU EMPLOYEE OR STUDENT?
The participation of OHSU students or employees in OHSU research is completely voluntary and you are
free to choose not to serve as a research subject in this protocol for any reason. If you do elect to
participate in this study, you may withdraw from the study at any time without affecting your
relationship with OHSU, the investigator, the investigator’s department, or your grade in any course. If
you would like to report a concern with regard to participation of OHSU students or employees in OHSU
research, please call the OHSU Integrity Hotline at 1-877-733-8313 (toll free and anonymous).

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