Attachment R -- Information Sheet for Patient Interviews and Observations

ATTACHMENT R

Information Sheet for Patient Interviews and Observations

Research Study Title: Patient-Reported Health Information Technology and Workflow 

Principal Investigator: Pascale Carayon, PhD

How to contact the study staff: call Randi Cartmill (project manager) at 608-890-2185 or Andrea Hassol (project director) at 617-349-2488.

Who to call if you have questions about being a research subject: University of Wisconsin Hospital and Clinics Patient Relations Representative at 608-263-8009

This sheet provides key information you need to know about this research study. Taking part in a research study is voluntary. You can stop taking part in this study at any time without any penalty. Feel free to ask the researchers any questions you have about this study.

The purpose of the research study: We are asking you to take part in this study because patients at your clinic sometimes use computer technology to share information with clinic staff. Patients may do this by using secure websites called patient portals to make appointments, request medication refills or view some of their medical records (like lab test results). Patients may fill out forms using a computer or sending secure email to the clinic. Finally, patients may also share information about their symptoms (like pain or fatigue), the results of tests they did at home (like taking their blood pressure), or the medications they use.

Agency for Healthcare Research and Quality (AHRQ), part of the U.S. Department of Health and Human Services, is funding this study. The research team is from Abt Associates, the University of Alabama-Birmingham, and the University of Wisconsin-Madison. Researchers will learn how small and medium-sized practices can use computer technology to gather information from patients. They will also examine how practices use the information that patients provide.

Main procedures you will undergo if you take part in this research study: We would like to interview you about how you use technology to share information with the clinic. For example, was it difficult for you to learn how to use the technology? How long does it take you to use it? Are there challenges in using the technology? What has helped you to use it? We would also like to observe your doctor and nurse when they are talking with you, to see how they use the information that you shared. These interviews and observations will help us understand how the clinic uses information technology to gather information from patients and how they use the information you give them. If you agree, we will record your interview and type up your responses. To protect your privacy, we won’t record your name or other information that could be used to identify you. Everything we discuss today in the interview and observation will be kept confidential to the extent permitted by law, including Section 944(c) of the Public Health Service Act 42 U.S.C. 299c-3(c).  That law requires that we only use the information collected today for this research project.

How long you will be in the study: The interview will take approximately 30 minutes. The observation would take place while you are talking with a physician or other clinic staff. It will last approximately 15-20 minutes.

If I decide to start the study, can I change my mind? Yes, you may change your mind at any time and stop taking part in this study. If you decide not to participate or change your mind about participating, you will not lose any benefits and your health care will not be affected.

Main risks of taking part in this research study: This research has very little risk. The researchers will be careful not to ask you for any information that could identify you. If any such information is accidentally recorded during your interview, it will be removed from the recording and typed interview transcript as soon as possible. During the observation, the researchers will not record any information that could identify you. Although very unlikely, there is a slight possibility that someone outside of the project could see your data. Only researchers associated with this project will have access to the data, which will be stored in locked filing cabinets and on a secure password-protected computer server.

Possible benefits of taking part in this research study: This research could help your clinic. If the clinic is interested, researchers will give suggestions on how to improve the ways they collect and use information reported by patients. It could also have benefits for society by improving the ways small and medium-sized practices collect and use information reported by patients using computer technology.

Participation in the interview or observation implies your consent to be in this study.

If you have any questions about your rights as a research subject or complaints about the research study that you could not resolve with the study team contact UWHC Patient Relations Representative at 608-263-8009 or the University of Wisconsin Medical Foundation Patient Relations Representative at 800-552-4255 or 608-821-4819.

Thank you for helping with this project.