Clinical trial Recruiting at 4 sites Interventional Ages 18 and up

Whole Health Coaching added to VA pain management teams for Veterans with chronic pain

Official title: Pain Management Teams Using Whole Health to Optimize Function and Safety in Veterans: The TEAMWORK Trial

Run by VA Office of Research and Development · NCT07149870 · Data updated 2026-11-12

This trial tests whether adding Whole Health Coaching to VA pain management teams helps Veterans on long-term opioids improve function and use opioids more safely.

More Chronic Pain trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment432 (estimated)
SponsorVA Office of Research and Development
Federal
Locations5 sites (Birmingham, Alabama and 4 other locations)
StatusRecruiting
StartedNovember 20, 2025
Main results expectedOctober 1, 2029
Study endsOctober 1, 2029
Registry record updatedAugust 17, 2026
Trial IDNCT07149870 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Veterans with high-impact chronic pain who have been on long-term opioid therapy (>90 days) and who have at least one opioid safety concern and are receiving care from a participating VA pain management team.

Probably not a fit

Patients not on long-term opioids, without opioid safety concerns, or not receiving care at a participating VA pain management team are unlikely to benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multisite randomized pragmatic effectiveness-implementation hybrid type 2 trial will enroll 432 Veterans with high-impact chronic pain on long-term opioid therapy and randomly assign them to Pain Management Team usual care (PMT-UC) or PMT plus Whole Health Coaching (PMT-WHC). The primary outcome is a composite of pain-related interference and opioid safety, with secondary outcomes including wellbeing, physical functioning, and buprenorphine initiation and maintenance, plus implementation and budget impact analyses. Both groups receive baseline PMT evaluation and follow-up visits determined by clinicians, and participants complete telephone questionnaires at baseline, 1, 3, 6, and 12 months. Investigators will also evaluate facilitation strategies to build and sustain PMTs at participating VA sites.

Why it matters

Potential benefit: If successful, adding Whole Health Coaching could improve pain-related function and reduce opioid-related risks for Veterans on long-term opioid therapy.

How similar studies have gone: Whole Health Coaching has shown benefits for self-management and wellbeing in VA and other settings, but combining WHC with PMTs specifically to improve opioid safety is a relatively novel approach with limited direct trial evidence.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. High-impact chronic pain (defined using the Graded Chronic Pain Scale - Revised).
2. Active prescription for long-term opioid therapy (LTOT; including full agonist and buprenorphine) (\>90 days continuous prescription).
3. Exhibit evidence of at least ONE opioid safety concern (\*indicators of opioid safety concerns described below).

   * Opioid safety concerns for inclusion purposes include:

     1. moderate-to-high dose opioid prescription (morphine equivalent daily dose \>60mg)
     2. comorbid conditions that increase the risk of full-agonist opioids including chronic pulmonary disease (e.g., emphysema, chronic bronchitis, asthma, or other breathing problems), sleep apnea, chronic kidney disease, chronic hepatitis or cirrhosis
     3. active high-risk co-prescriptions, including long-term benzodiazepine prescription, gabapentin or pregabalin, nonbenzodiazepine hypnotic agents or sedative hypnotics, or skeletal muscle relaxants
     4. a positive TAPS or AUDIT-C score
     5. reported score of \>8 as measured by the Prescribed Opioids Difficulties Scale (PODS).

Exclusion Criteria:

1. Moderate to severe cognitive impairment as measured by the Blessed Orientation Memory Concentration (BOMC) screening tool.
2. Inability to read or understand English.
3. Severely impaired hearing or speech that would preclude participation in telephone interviews or appointments with the Whole Health Coach.
4. Terminal illness/disease with a prognosis of \<12 months.
5. Planned move/relocation outside of the treatment areas of the participating enrolling study sites.
6. Participants actively working with a Whole Health Coach or who have worked with a Whole Health Coach in the 6-months prior to enrollment.
7. Major surgical procedure planned during the study treatment or follow-up period.
8. a recent suicide attempt, defined as documented and/or reported suicide attempt within 90 days of the screening date.

Where it's running

  • Birmingham VA Medical Center, Birmingham, AL
    Birmingham, Alabama, United States
    Recruiting
  • Rocky Mountain Regional VA Medical Center, Aurora, CO
    Aurora, Colorado, United States
    Recruiting
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
    West Haven, Connecticut, United States
    Recruiting
  • Boise VA Medical Center, Boise, ID
    Boise, Idaho, United States
    Recruiting
  • Central Arkansas Veterans Healthcare System , Little Rock, AR
    Little Rock, Arkansas, United States
    Withdrawn

Study contacts

  • Principal investigator: Sara Edmond, PhD — VA Connecticut Healthcare System West Haven Campus, West Haven, CT
  • Study coordinator: Danielle M Wesolowicz, PhD
  • Email: Danielle.Wesolowicz@va.gov
  • Phone: (203) 932-5711

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.