Attachment P -- Information Sheet for Clinicians

ATTACHMENT P

Information Sheet for Clinicians

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: You are being invited to participate in this study because you work in a practice that uses health information technology to collect or use information provided by patients. Patient-reported health information technology can include:

• Patient portals (sometimes referred to as [electronic] personal health records or PHRs; allow patients to view portions of their medical records [e.g., laboratory test results] and support other health-related tasks such as making appointments or requesting medication refills. Some patient portal applications exist as stand-alone Web sites; other portal applications are integrated into an existing electronic health record [EHR] system);

• Secure messaging with patients (use of secure e-mail between patients and clinicians, typically using the secure messaging functionality in the EHR and/or patient portal); and

• e-forms (surveys that are administered using computerized media [e.g., tablets, laptops] to collect information from patients using pre-formatted forms before or during patient visits).

Patients may use these systems to share information such as symptoms (e.g., pain, fatigue), results of self-testing (e.g., blood glucose levels, blood pressure), weight questions and concerns, or over-the-counter medication use.Main procedures you will undergo if you take part in this research study: You are invited to participate in this study in several ways: (1) by allowing researchers to observe you doing your work related to the use of patient-reported information and health IT, (2) by participating in an interview about the use of patient-reported information and health IT, and (3) by completing a survey describing your attitudes about and perceptions of your work using patient-reported information and health IT. During the observation, researchers will watch how you collect patient-reported information with health information technology and how you use the information collected that way. The researchers will ask questions to clarify their understanding of what they observe. In addition, some physicians who hold a leadership position will be asked to participate (4) by participating in an interview about their practice to provide context before the researchers’ visit, and (5) by reviewing work process diagrams created by researchers after the visit and confirming that they are accurate. If you agree, we will record your interview and type up your responses. In order to contact you over the course of the study, researchers will retain your contact information. However, identifying information about you will never be linked to your observation, interview, or survey data. We would like to assure you that all the information you share with us 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 information collected for research conducted or supported by AHRQ that identifies individuals or establishments be used only for the purpose for which it was supplied.

This research is sponsored by Agency for Healthcare Research and Quality (AHRQ), an agency within the U.S. Department of Health and Human Services, and is being led by researchers from Abt Associates, the University of Alabama-Birmingham, and the University of Wisconsin-Madison. The purpose of this research is to examine how patient-reported information and health information technology can be used well in small and medium-sized practices. For example, more and more physicians’ practices are using secure messaging for communication between patients and their providers, and we are interested in when you check email, how triage of incoming emails are completed, how you decide whether a patient should come in for an appointment, whether emails become part of a patient’s medical records and so on.

How long you will be in the study: The researchers will visit your practice for 3 to 4 days. In that time you would be asked to fill out a survey for approximately 15 minutes, to permit researchers to observe you for 2 hours and to complete an interview for one hour. If you are a physician leader, you may also be asked to participate in another interview about the practice that will take approximately 1 hour to complete and to review the Workflow Process Map(s) for approximately 1 hour.

Main risks of taking part in this research study: There is minimal risk associated with these activities. Researchers will be careful to minimize disruption to your work. No identifying information about you will be collected. The surveys will be anonymous. If you agree, your interview will be audio-recorded and transcribed, and no information that could identify you will be included in the interview transcript. Any such information that is accidentally collected will be permanently removed from the transcript and audio recordings as soon as it is noticed. While taking notes about your observation, the researchers will be careful not to include any information that could identify you. There is a minimal possibility of a breach of confidentiality occurring. Only researchers associated with this project will have access to the data gathered. All collected data will be stored in locked file cabinets in a controlled access, locked room and on a secure password-protected computer server.

Possible benefits of taking part in this research study: If your practice is interested, the researchers will provide you with suggestions for improving the ways you collect and use patient-reported information so that you can optimize your workflows. In addition, this research could provide substantial benefits to society by providing information to improve how small and medium-sized practices collect and use patient-provided information.

If I decide to start the study, can I change my mind? Participation in this study is voluntary. You may change your mind at any time and discontinue your participation in this study. If you decide not to participate or change your mind about participating, you will not be penalized or lose any benefits you would have otherwise been entitled to. Participation in the study implies consent.

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.