Original Articles

Tailored to Fit

How an Implementation Framework Can Support Pragmatic Pain Care Trial Adaptation for Diverse Veterans Affairs Clinical Settings

Purcell, Natalie PhD, MPA^*,†; Becker, William C. MD^‡,§; Zamora, Kara A. MA^*,†; McGrath, Sarah L. MA^*; Hagedorn, Hildi J. PhD^∥,¶; Fabian, Eva R. MPH^*; McCamish, Nicole MA^*; Seal, Karen H. MD, MPH^*,†

Author Information

^*San Francisco VA Health Care System

^†University of California, San Francisco, CA

^‡VA Connecticut Healthcare System, West Haven

^§Yale School of Medicine, New Haven, CT

^∥Minneapolis VA Health Care System

^¶University of Minneapolis, Minneapolis, MN

Supported by the National Institutes of Health (NIH) through cooperative agreement U24AT009769 and cooperative agreement UG3 AT009765-01 from the National Center for Complementary & Integrative Health (NCCIH). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, the Department of Veterans Affairs, or any other institution.

This manuscript is a product of the NIH-DoD-VA Pain Management Collaboratory. For more information about the Collaboratory, visit https://painmanagementcollaboratory.org/.

The authors declare no conflict of interest.

Correspondence to: Natalie Purcell, PhD, MPA, San Francisco VA Health Care System, Integrative Health (T-31), 4150 Clement Street, San Francisco, CA 94121. E-mail: [email protected].

Medical Care 58():p S80-S87, September 2020. | DOI: 10.1097/MLR.0000000000001376

Abstract

Background:

Veterans Affairs (VA) has rolled out a holistic, multicomponent Whole Health care model nationwide, yet no pragmatic trials have been conducted in real-world clinical settings to compare its effectiveness against other evidence-based approaches for chronic pain management in veterans.

Objectives:

We describe the adaptation of the first large pragmatic randomized controlled trial of the Whole Health model for chronic pain care for diverse VA clinical settings.

Research Design:

Informed by the Promoting Action on Research Implementation in Health Systems implementation framework, we conducted qualitative semistructured interviews to obtain feedback on trial design from VA leadership, frontline clinicians, and veterans with chronic pain at 5 VA enrollment sites. Next, we convened in-person evidence-based quality improvement (EBQI) meetings with study stakeholders (including frontline clinicians and administrators) at each site to discuss study design; review interview themes; and identify site-specific barriers, facilitators, and approaches to implementation. Ethnographic observations from EBQI meetings provided additional insight into implementation strategies.

Subjects:

Seventy-four veteran and VA staff stakeholders were interviewed; 71 stakeholders participated in EBQI meetings.

Results:

At each site, unique clinical contexts and varying resources for Whole Health and pain care delivery affected plans for trial implementation. We present examples of local adaptations that emerged through the formative evaluation process to facilitate implementation and yield a more pragmatic trial design.

Conclusions:

A systematic formative evaluation can facilitate engagement and buy-in of study stakeholders. Locally tailored pragmatic implementation strategies may improve the likelihood of successful trial execution as well as future implementation of evidence-based pain care approaches in real-world clinical settings.

Article Keywords

Keywords
pragmatic trials, formative evaluation, implementation science, qualitative methods, chronic pain, integrative health, veterans

Secondary Logo

Journal Logo

Tailored to Fit

How an Implementation Framework Can Support Pragmatic Pain Care Trial Adaptation for Diverse Veterans Affairs Clinical Settings