Att D Script for Verbal consent

OMB #0990-0421

Expires: 10/31/2020

Attachment D. Script for verbal consent: MAXIMIZING THE PROMISE OF HEALTH INFORMATION TECHNOLOGY THROUGH THE PROMOTION OF INTEROPERABILITY: VALUE-BASED CARE

TITLE OF STUDY:	Maximizing the Promise of Health Information Technology through the Promotion of Interoperability: Value-Based Care
INVESTIGATOR:	The Urban Institute
PHONE NUMBER:	202-261-5605
SPONSOR:	U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation (ASPE) and the Office of the National Coordinator for Health IT (ONC)

[DIRECTIONS FOR INTERVIEWERS: Read the below information to the participant(s) and ask each participant to respond to the two consent questions: (1) for study participation and (2) for permission to record the discussion. Do not record the process of obtaining consent. Do not record the interview if the respondent declines consent to record.]

Thank you for taking the time to meet with us today. The Urban Institute is being contracted by the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Planning and Evaluation (ASPE) and the Office of the National Coordinator for Health IT (OMH) to conduct a study of barriers and facilitators to integrating data from a major exchange partner and to identify potential interventions to strengthen data integration.

You are being asked to participate in this research study. Before we begin we want to obtain your verbal consent to participate in the study. As part of obtaining your consent we will share information about the study’s purpose, procedures, and any benefits or risks of the study. Once we review these aspects of the study and you’ve had a chance to ask any questions, we will ask if you consent to participate in the study. Additionally, we would like you to not that according to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0990-0421. The time required to complete this information collection is estimated to average 1 hour per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: U.S. Department of Health & Human Services, OS/OCIO/PRA, 200 Independence Ave., S.W., Suite 336-E, Washington D.C. 20201, Attention: PRA Reports Clearance Officer.

The purpose of the study is to learn about the local efforts to promote data integration to support the delivery of value-based care.

We are asking for your participation in this interview to hear about your professional perspective on and experiences with [insert name of the site]’s work related to data integration to support value-based care.

For this study, Urban researchers will be interviewing up to 35 individuals from 5 sites across the country. The selection criteria ASPE and ONC used to identify sites aimed to select examples with advanced data integration efforts relative to the rest of the country. The site selection criteria also took into consideration whether sites had relatively mature value-based care efforts and diversity across sites in the dominant electronic health record (EHR) vendors used. [Site name] was selected as one of the 5 sites for this study.

During the interview will we ask you to discuss your professional perspective on what data integration currently looks like on the ground, what factors from your experience have facilitated or impeded data integration, and how it is being used to support the goals of value-based care.

The information that we collect as part of this study will be analyzed and shared in a summary report for ASPE and ONC. The report will not identify you by name or specific job title, but will summarize all the information we learned about [insert site name].

We will also ask for your consent to record the discussion for transcription purposes. As part of Urban’s study contract, we will provide transcripts to ASPE and OMH, but we will redact all identifying information from the transcripts. Specifically, Urban researchers will remove any identifying information, such as names or job titles, before sharing transcripts with ASPE and ONC.

There are no known risks to this study. Participating in the study may not provide a direct benefit to you, but information from the study will be helpful to inform federal, state and health system administrators’ practices and policies regarding how to better promote data integration.

Participation in the study is completely voluntary and you may end participation at any time. Your refusal to participate or withdraw from the study will not result in any penalty. There is no compensation for participating in the study.

Do you have any questions for me about the study before we get started?

If you have any additional questions about the study, you may contact me [interviewer/site liaison] at [contact email and phone number] or Christal Ramos, the study’s lead researcher at Urban, at 202-261-5605.

[Consent Question 1] Do you consent to participate in the study? [yes/no]

[If yes, Consent Question 2] Do you consent to allow us to record the discussion? [yes/no]