CERSI Collaborator: University of California San Francisco: Urmimala Sarkar, MD, MPH; Courtney Lyles, PhD

FDA Collaborators: Richardae Araojo, PharmD, MS (OMHHE); Christine Lee, PharmD, PhD (OMHHE); Michelle Tarver, MD, PhD (CDRH)

Project Start Date: 04/2020
Project End Date: 08/2022

Regulatory Science Challenge

Patients have demonstrated interest in using digital tools to manage their health. Additionally, clinicians have shown interest in virtual reality (VR) as an adjunct or replacement pain management treatment. Therapeutic VR provides an alternative approach to managing pain with medications, and randomized trials demonstrate its effectiveness in reducing pain among hospitalized patients. However, VR therapeutic products are primarily tested in well-resourced, controlled settings serving mostly white, non-Hispanic patients with high educational attainment. It remains unclear if VR is a feasible or effective approach for pain management in real-world settings serving diverse, low-income patients.

Project Description and Goals

As the FDA evaluates VR use in health care, this project will help advance understanding of the major barriers and facilitators to VR implementation among diverse patient populations. We will do so by conducting usability testing of VR for opioid-sparing pain management in a safety-net healthcare system serving racial and ethnic minority patients using an implementation science framework. Our aims are to (1) conduct qualitative interviews and usability tests with 12-20 healthcare workers who may be involved in VR implementation (e.g., providers, front-line staff, and information technology staff) and 12-20 patients who may receive VR treatment and (2) qualitatively analyze interview transcripts from multiple perspectives to characterize usability barriers and facilitators.

Research Outcomes/Results

Researchers completed interviews with 15 healthcare stakeholders and 15 patients with chronic pain to assess barriers and facilitators to implementing VR in academic, community, and safety-net settings. Results from our healthcare worker interviews revealed that there is broad interest in VR as a treatment modality, but the technology will require significant adaptation to address the needs of diverse populations and the settings that care for them. Results from our patient interviews revealed that the VR headset was usable and acceptable among most participants.

Research Impacts

Virtual reality (VR) therapeutic products have primarily been tested in well-resourced, controlled settings serving mostly white, non-Hispanic patients with high educational attainment. The purpose of our study was to understand if VR is a feasible and effective approach for pain management in a safety-net healthcare system serving diverse patients. We conducted interviews with 15 healthcare workers and 15 patients with chronic pain. The impact of our project is in alignment with the metrics set by the FDA:

1. Advancing regulatory science: This project included patient perspectives to help inform regulatory decision-making of VR for pain management.
2. Disseminating scientific knowledge: This project produced one publication, with one more in progress. Project findings were also presented at AcademyHealth, the National Institutes of Health’s Conference on the Science of Dissemination and Implementation, and the Society of General Internal Medicine’s Annual Meeting.
3. Catalyzing action: Researchers found that healthcare stakeholders and patients are interested in VR use. This study serves as a catalyst for future research to evaluate the use of VR for chronic pain among diverse populations in real-world settings, including engagement, effectiveness, and sustainability of VR for chronic pain treatment.

Publications

Sarkar U, Lee JE, Nguyen KH, Lisker S, Lyles CR. Barriers and Facilitators to the Implementation of Virtual Reality as a Pain Management Modality in Academic, Community, and Safety-Net Settings: Qualitative Analysis. J Med Internet Res. 2021 Sep 22;23(9):e26623. doi: 10.2196/26623. PMID: 34550074; PMCID: PMC8495579.