Pragmatic Trial of WHT vs. PC-GE to Promote Non-Pharmacological Strategies to Treat Chronic Pain in Veterans

Completed · Not applicable

Conditions studied: Chronic Pain

In brief

The overarching goal of this Pain Management Collaboratory Demonstration project is to test a new Whole Health paradigm for chronic pain care, emphasizing non-pharmacological pain self-management that is hypothesized to reduce pain symptoms and improve overall functioning and quality of life in Veterans. In UH3 Aim 1, the investigators will conduct a 12-month pragmatic effectiveness trial at 6 VA sites across the country to test whether veterans with moderate to severe chronic pain randomized to receive the Whole Health Team (WHT) intervention are more likely than those receiving Primary Care Group Education (PC-GE) to: Hypothesis 1: Experience improved pain interference (primary outcome), pain intensity, functioning and quality of life (secondary outcomes); Hypothesis 2: Decrease use of higher-risk pain medications, including opioids, or high-risk combinations; Hypothesis 3: Engage in a greater number of non-pharmacological pain management activities; and Hypothesis 4: Experience improved mental health-related symptoms, including sleep problems and suicidality. In addition, both the WHT and PC-GE arms will be compared to a third group of veterans randomized to Usual Primary Care (UPC, Control) on the same primary and secondary outcomes above. After the baseline assessment, masked telephone assessments will be administered to participants at 3, 6, 9, and 12 months. UH3 Aim 2 is to conduct a process evaluation of the two active interventions (WHT and PC-GE) and a budget impact analysis that includes costs to implement and execute the two active interventions as well as the control condition (UPC) to inform the development of an implementation toolkit for scaling and dissemination. Eligible participants are veterans reporting moderate to severe chronic pain present every day or nearly every day for ≥ 6 months. The total sample size for the population is based on our main study aim/hypothesis and is N=764. This breaks down to n=343 in the WHT intervention, n=339 in the PC-GE intervention, and N=82 in the Usual Primary Care arm (Control). Results of this UG3/UH3 Pain Management Collaboratory Demonstration project will contribute to the overall mission of the NIH/VA/DoD initiative to build national-level infrastructure that supports non-pharmacologic pain management in veterans and military service personnel.

Key facts

Study ID: NCT04330365
Run by: San Francisco Veterans Affairs Medical Center
People needed: 793
Starts: 2020-09-15
Expected to finish: 2025-01-23
Last updated by the study team: 2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Participants must meet the following inclusion criteria to be enrolled in the study:
Assigned to a VA PCP;
Report pain present every day or nearly every day for ≥ 6 months using a phone eligibility screener; and
PEG score of ≥ 5 (including at baseline assessment)

You may not qualify if…

Candidates with any of the exclusion criteria at baseline will be excluded from study participation:
Moderate or severe cognitive impairment as determined by a failed 6-item, validated cognitive screener on initial phone screening (See Appendix A: Telephone Eligibility Screen/Script);
Active suicidality as determined by medical record review, standardized assessment (PHQ-9) and/or is unable to attend study visits because of an unstable or severe psychiatric or medical condition or is receiving palliative or hospice care; or
Any other factors that would interfere with study participation including inability to communicate by telephone, VTEL or VVC; being a non-English speaker; plans to relocate within 12 months and concurrent participation in another pain-related study.

Where it is running

SFVAHCS — San Francisco, California, United States
VA Connecticut — West Haven, Connecticut, United States
James A. Haley Veterans Hospital — Tampa, Florida, United States
Bedford VAMC — Bedford, Massachusetts, United States
VA St. Louis Health Care System — St Louis, Missouri, United States
VAPHCS — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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