Status:
RECRUITING
Pain Management Teams Using Whole Health to Optimize Function and Safety in Veterans: The TEAMWORK Trial
Lead Sponsor:
VA Office of Research and Development
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
This multisite pragmatic effectiveness-implementation hybrid type 2 trial will randomize 432 patients to compare Pain Management Team - Usual Care (PMT-UC) vs. Pain Management Team Usual Care + Whole ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
November 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
432 Patients enrolled
Trial Details
Trial ID
NCT07149870
Start Date
November 20 2025
End Date
October 1 2029
Last Update
December 12 2025
Active Locations (5)
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1
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States, 35233-1927
2
Central Arkansas Veterans Healthcare System , Little Rock, AR
Little Rock, Arkansas, United States, 72205
3
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045-7211
4
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516-2770