Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
by Karen Seal (ucsf)
Photo of Karen Seal
Karen Seal

Description

Summary

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 5 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=745. This breaks down to n=341 in each of the active interventions (WHT and PC-GE) and N=63 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.

Official Title

Implementation of a Pragmatic Trial of Whole Health Team vs. Primary Care Group Education to Promote Non-Pharmacological Strategies to Improve Pain, Functioning, and Quality of Life in Veterans

Keywords

Chronic Pain

Eligibility

You can join if…

Open to people ages 18 years and up

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 CAN'T join 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.

Locations

  • SFVAHCS accepting new patients
    San Francisco California 94121 United States
  • VAPHCS accepting new patients
    Portland Oregon 97239 United States

Lead Scientist at UC Health

  • Karen Seal (ucsf)
    Dr. Karen Seal is a Professor of Medicine and Psychiatry at the University of California, San Francisco (UCSF). She is based at the San Francisco VA Health Care System (SFVAHCS) where she is the Director of the Integrated Care Clinic for Iraq and Afghanistan Veterans and Director of the Integrated Pain Team (IPT) Clinic.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
San Francisco Veterans Affairs Medical Center
ID
NCT04330365
Study Type
Interventional
Last Updated