consent

informed consent to take part in a research study

TITLE OF STUDY: ONC/HITECH EP Clinical Quality Measures: Patient Focus Group Discussions to Inform Design of Quality Measures

INVESTIGATOR: Karen Schifferdecker, PhD, The Dartmouth Institute for Health Policy and Clinical Practice

PHONE NUMBER: (603) 653-3450

SPONSOR: Booz Allen Hamilton

What is the purpose of this form?

You are being asked to participate in a research study. This form describes the purpose of the study, how the research will be used, any benefits and risks to you, and your rights as a participant. If you agree, you will be asked to sign this consent form. Once you sign it, we will give you a signed and dated copy to keep.

Why is this study being done?

The Dartmouth Institute (TDI) is working with ONC to develop potential clinical quality measures that may be used in the future to assess how clinical practices are doing in delivering care to patients. To develop these potential measures, TDI would like to understand what is important to patients like you so that the patient experience is included as a potential quality measure.

What is being studied?

The research team is collecting information to understand how Heart Failure affects the lives of patients with this condition and what is most important for them to be able to change or fix.

What do I need to know about this study?

Information you provide will be summarized with information provided by other patients. This information will be shared with ONC and other partners. No information will be shared that has your name on it or that could be attributed to you. Information will only be reported in an aggregated fashion.

What are the potential risks of being in the study?

There are no anticipated risks to you related to participating in the study. Your name will never be shared or attached to any information that is shared.

CONFIDENTIALITY

Only the research team at The Dartmouth Institute will have access to the recordings and lists of participants. The recordings and participant lists will be saved in a secured folder with access restricted to the team members, and the lists of participant names will not be stored with the recordings. All hard copies will be saved in locked cabinets in office buildings that require access cards for entry to Dartmouth staff only. Recordings will be destroyed at the end of the study.

Who do I contact if I have questions?

If you have questions or concerns about the study, please contact the project director, Karen Schifferdecker, PhD, The Dartmouth Institute, (603) 653-3450.

VOLUNTEER’S STATEMENT

You agree that you have been given a chance to ask questions about this research study. These questions have been answered to your satisfaction. You may contact Dr. Schifferdecker if you have any more questions about taking part in this study.

Your participation in this research project is voluntary. The research team may decide at any time that you should no longer participate in this study.

You agree to participate in this study. You will be given a copy of this signed and dated form for your own records.

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Study Participant (signature) Date

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Print Participant’s Name

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Person who explained this study (signature) Date

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