Whole Health Coaching added to VA pain management teams for Veterans with chronic pain
Pain Management Teams Using Whole Health to Optimize Function and Safety in Veterans: The TEAMWORK Trial
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 432 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 5 sites (Birmingham, Alabama and 4 other locations) |
| Trial ID | NCT07149870 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
INCLUSION CRITERIA:
1. High-impact chronic pain (defined using the Graded Chronic Pain Scale - Revised).
-AND-
2. Active prescription for LTOT (\>90 days continuous prescription). -AND-
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 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 benzodiazepine prescription (any dose of long-term treatment), gabapentin prescription (1800mg or higher) or pregabalin prescription (150mg or higher)
4. 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.
5. a positive TAPS score
6. a positive AUDIT-C score
7. presence of any adverse events as measured by the adverse effects checklist administered during screening
8. 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.
-OR-
2. Current/active prescription for buprenorphine or receipt of buprenorphine in the previous 6-months.
-OR-
3. Inability to read or understand English. -OR-
4. Severely impaired hearing or speech that would preclude participation in telephone interviews or appointments with the Whole Health Coach.
-OR-
5. Terminal illness/disease with a prognosis of \<12 months. -OR-
6. Planned move/relocation outside of the treatment areas of the participating enrolling study sites.
-OR-
7. 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-
8. Major surgical procedure planned during the study treatment or follow-up period.
-OR-
9. a recent suicide attempt, defined as documented and/or reported suicide attempt within 90 days of the screening date.
Where this trial is running
Birmingham, Alabama and 4 other locations
- Birmingham VA Medical Center, Birmingham, AL — Birmingham, Alabama, United States (Recruiting)
- Central Arkansas Veterans Healthcare System , Little Rock, AR — Little Rock, Arkansas, United States (Withdrawn)
- 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)
Study contacts
- Principal investigator: Sara Edmond, PhD — VA Connecticut Healthcare System West Haven Campus, West Haven, CT
- Study coordinator: Sara Edmond, PhD
- Email: sara.edmond@va.gov
- Phone: (203) 932-5711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.