Usability Testing of Virtual Reality for Opioid-Sparing Pain Management Among Diverse Patients (OC)

OMB Control No: 0910-0497 Expiration Date: 10/31/2020

Paperwork Reduction Act Statement: According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not 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 0910-0497. The time required to complete this information collection is estimated to average 75 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRAStaff@fda.hhs.gov.

The study we are conducting is on behalf of the U.S. Food and Drug Administration (FDA).

Thanks in advance for your responses.

Qualitative Interview Guide

Health Care Workers

Study Title: Usability Testing of Virtual Reality for Opioid-Sparing Pain Management Among Diverse Patients

Step 1. Introductions and description of quality improvement component of this study

Step 2. Provide stakeholder with incentive payment

• Have participant sign (or e-sign) acknowledgement of payment

• Provide participants with $100 as a token of appreciation (or send, if provided electronically)

Step 3. Interview questions:

Interviewee and organization information

1. Please describe your role and how long you have worked in it

2. Please tell us about your organization (if applicable)

   1. Years in operation

   2. Mission/ goal

3. What is your role in terms of the pain management approaches that are used in your organization?

4. Can you outline in broad terms the current pain management programs at your organization in: (post-surgery only? Outpatient care? Overall?)

5. Have you heard of virtual reality to manage pain? What are your thoughts about this?

6. Have you ever used virtual reality before? What was the setting?

External factors

7. Are there people at your facility who have been particularly important in helping implement digital health? What would it take to get them engaged in an implementation of VR?

8. What policies/ incentives have been/ do you expect to be instrumental in the success of a VR tool?

9. What challenges do you anticipate related to implementing VR, or scaling? What about the facilitators to scaling?

10. To what extent might implementing VR provide an advantage to your organization compared to other organizations in your area?

Internal factors

11. Is there a strong need for pain management interventions? How do people feel about existing programs?

12. How might needs for VR be different at your site than elsewhere?

13. How do you think your organization’s culture might affect implementation of a digital health tool using VR?

14. Would implementing VR require a change to your workflow?

15. What other interventions might you bundle with it?

16. What are your requirements for integrating/ accessing new technologies, such as VR, in the electronic health record?

17. Do you currently have sufficient resources to support digital health implementation? A specific VR implementation?

    1. What resources would you need to do so, if not? What infrastructure changes might be needed?

Intervention characteristics and process for implementation

18. If you were to use a VR tool in clinical care, what level of evidence would you expect beforehand? What would be your metrics for success? Why might you choose VR for pain management over an alternative?

19. What would you need to know in order to think it was worth it?

20. What would you need in order to feel comfortable recommending VR treatment?

21. What types of implementation or other operational challenges might you anticipate encountering? Are there implementation leaders or champions that might go above and beyond to implement a tool like VR?

Characteristics of individuals

22. How would you feel about an intervention like VR being implemented in your setting? Do you think it would be effective? What do you think your colleagues would think?

23. What do you think your patients would think of VR for pain management? How might this vary by patient characteristics (e.g. race, ethnicity, socioeconomic status)?

    1. PROBE: Are there certain segments of the population you’d be less likely to consider for VR treatment?