Pain Management Teams Using Whole Health to Optimize Function and Safety in Veterans: The TEAMWORK Trial
Recruiting now · Not applicable
Conditions studied: Chronic Pain
In brief
The focus of this study is to determine whether adding Whole Health Coaching (WHC) improves pain care among adults with chronic pain and who are currently working with a pain management team (PMT) at the VA.
Key facts
- Study ID
- NCT07149870
- Run by
- VA Office of Research and Development
- People needed
- 432
- Starts
- 2025-11-20
- Expected to finish
- 2029-10-01
- Last updated by the study team
- 2026-04-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- INCLUSION CRITERIA:
- High-impact chronic pain (defined using the Graded Chronic Pain Scale - Revised).
- AND-
- Active prescription for LTOT (>90 days continuous prescription). -AND-
- Exhibit evidence of at least ONE opioid safety concern (*indicators of opioid safety concerns described below).
- Opioid safety concerns for inclusion purposes include:
- moderate-to-high dose opioid prescription (morphine equivalent daily dose >60mg)
- comorbid conditions that increase the risk of opioids including chronic pulmonary disease (e.g., emphysema, chronic bronchitis, asthma, or other breathing problems), sleep apnea, chronic kidney disease, chronic hepatitis or cirrhosis
- active high-risk co-prescriptions, including benzodiazepine prescription (any dose of long-term treatment), gabapentin prescription (1800mg or higher) or pregabalin prescription (150mg or higher)
- risk of substance use and/or potential opioid misuse as evidenced by unexpected urine toxicology findings in past 6-months OR any documented active substance use disorder (other than tobacco or caffeine) as evidenced by at least 2 encounters within the previous 12-months with a substance use disorder diagnosis.
- a positive TAPS score
- a positive AUDIT-C score
- presence of any adverse events as measured by the adverse effects checklist administered during screening
- reported score of >8 as measured by the Prescribed Opioids Difficulties Scale (PODS).
You may not qualify if…
- Moderate to severe cognitive impairment as measured by the Blessed Orientation Memory Concentration (BOMC) screening tool.
- OR-
- Current/active prescription for buprenorphine or receipt of buprenorphine in the previous 6-months.
- OR-
- Inability to read or understand English. -OR-
- Severely impaired hearing or speech that would preclude participation in telephone interviews or appointments with the Whole Health Coach.
- OR-
- Terminal illness/disease with a prognosis of <12 months. -OR-
- Planned move/relocation outside of the treatment areas of the participating enrolling study sites.
- OR-
- Participants actively working with a Whole Health Coach or who have worked with a Whole Health Coach in the 6-months prior to enrollment.
- OR-
- Major surgical procedure planned during the study treatment or follow-up period.
- OR-
- a recent suicide attempt, defined as documented and/or reported suicide attempt within 90 days of the screening date.
Where it is running
- Birmingham VA Medical Center, Birmingham, AL — Birmingham, Alabama, United States (enrolling)
- Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado, United States (enrolling)
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven, Connecticut, United States (enrolling)
- Boise VA Medical Center, Boise, ID — Boise, Idaho, United States (enrolling)
- Central Arkansas Veterans Healthcare System , Little Rock, AR — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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