NCT07149870 Pain Management Teams Using Whole Health to Optimize Function and Safety in Veterans: The TEAMWORK Trial
| NCT ID | NCT07149870 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 432 participants |
| Start Date | 2025-11-20 |
| Primary Completion | 2029-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 432 participants in total. It began in 2025-11-20 with a primary completion date of 2029-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 the VA.
Eligibility 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.
Contact & Investigator
Sara Edmond, PhD
PRINCIPAL INVESTIGATOR
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Frequently Asked Questions
Who can join the NCT07149870 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07149870 currently recruiting?
Yes, NCT07149870 is actively recruiting participants. Contact the research team at sara.edmond@va.gov for enrollment information.
Where is the NCT07149870 trial being conducted?
This trial is being conducted at Birmingham, United States, Little Rock, United States, Aurora, United States, West Haven, United States and 1 additional location.
Who is sponsoring the NCT07149870 clinical trial?
NCT07149870 is sponsored by VA Office of Research and Development. The principal investigator is Sara Edmond, PhD at VA Connecticut Healthcare System West Haven Campus, West Haven, CT. The trial plans to enroll 432 participants.
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