CMS-10497 GHS FG Inform Consent

Draft – 05--13

Informed Consent to Participate in Research for Beneficiaries and Caregivers
Title of Research: Medicare Health Care Quality Demonstration Evaluation
You are being asked to participate in a research study. Before you decide if you want to take part in
this study, you need to read this Informed Consent form so that you understand what the study is
about and what you will be asked to do.
The Medicare Health Care Quality Demonstration Evaluation is a research study paid for by The
U.S. Centers for Medicare and Medicaid Services. This study is being conducted by RTI
International, a nonprofit research organization based in North Carolina. The purpose of this study
is to evaluate health care services provided under the demonstration by Gundersen Health System
through its Advanced Disease Coordination program. The purpose of the demonstration is to test
new ways to improve the quality of care and to improve the coordination of care that beneficiaries
receive.
If you agree to participate, you will be asked to take part in a focus group interview that will last
approximately two hours. You will be asked questions about the health care services you receive. If
you are a caregiver, you will be asked about services provided to the person whom you care for and
their experiences. We believe there are minimal risks to you from participating in this interview.
Every effort will be made to protect your confidentiality, but this cannot be guaranteed. We want to
assure you that we will not quote you by name in any reports that are written and provided to CMS.
There are no direct benefits to you from participating in this study. The Institutional Review Board
(IRB) at RTI International has reviewed this research.
Your decision to participate in this research study is completely voluntary. You can refuse any part
of the study and you can stop participating at any time. You can refuse to answer any question.
If you have any questions about this study, you may call Michael Trisolini, the RTI project director,
at 781-434-1752. If you have any questions about your rights as a study participant, you may call
RTI’s Office of Research Protection at 1-866-214-2043 (a toll-free number).
Your signature below indicates that you read the information provided above, have received
answers to your questions, and have freely decided to participate in this research.
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Date

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Signature of Participant
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Printed Name of Participant

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Date

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Signature of Person Obtaining Consent
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Printed Name of Person Obtaining Consent