Pain Management Teams Using Whole Health to Optimize Function and Safety in Veterans: The TEAMWORK Trial
TEAMWORK
2 other identifiers
interventional
432
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Nov 2025
Longer than P75 for not_applicable chronic-pain
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2025
CompletedFirst Posted
Study publicly available on registry
September 2, 2025
CompletedStudy Start
First participant enrolled
November 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2029
April 2, 2026
March 1, 2026
3.9 years
August 6, 2025
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite of Pain Interference and Opioid Safety
The primary outcome for the clinical trial is a composite of pain-related interference and opioid safety where success at the individual level is only met when pain-related interference and opioid safety improve. The pain component of the composite primary outcome, measured at 6-month follow-up, will be change in pain interference from baseline, measured on the Brief Pain Inventory - Interference scale, categorized as improved/not improved with improvement defined as a ≥1 point reduction in pain-related interference. The opioid safety component of the composite primary outcome will be defined as success in one or more of the following: (1) initiating and continuing buprenorphine for at least 90 days, or (2) evidence of an opioid taper (i.e., a \>25% reduction in daily full agonist opioid dose, including opioid discontinuation), at 6 months.
6 months
Secondary Outcomes (5)
Opioid Safety
6 months, 12 months
Well-Being Signs (WBS) Tool
6 months, 12 months
Pain Interference
6 months, 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form 6b
6 months, 12 months
Composite of Pain Interference and Opioid Safety
12 months
Other Outcomes (2)
World Health Organization - Quality of Life (WHOQOL- 2)
6 months, 12 months
Patients' Global Impression of Change (PGIC)
6 months, 12 months
Study Arms (2)
PMT-WHC
EXPERIMENTALThe PMT-WHC group will receive PMT Usual Care plus 8 sessions of Whole Health Coaching (WHC)
PMT-UC
ACTIVE COMPARATORThe PMT-UC group will receive PMT Usual Care
Interventions
Pain Management Team-Usual Care (PMT-UC) involves working with VA PMTs that includes working with PMTs comply with legislation requiring each medical center to have PMTs with expertise in pain, addiction, behavioral approaches, and rehabilitation approaches. PMTs will conduct multidisciplinary intakes (at least two provider types) with biopsychosocial assessments for all new patients. Follow-up care will be determined by the PMTs based on what is clinically indicated (with recommended minimum medication management follow ups at 1- 3- and 6-months for patients making medication changes).
Whole Health Coaching (WHC) begins by completing a Personalized Health Inventory (PHI), where progress is evaluated within 8 dimensions of health and wellness. The PHI culminates in defining personal values and overall goals for health and wellness (i.e., "What do you want your health for?"). This is used to create goals for a Personal Health Plan. The Plan emphasizes self-management strategies to manage pain. After the Plan is developed, ongoing support is provided from the Coach through 8 coaching sessions over approximately 5 months.
Eligibility Criteria
You may qualify if:
- 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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, 35233-1927, United States
Central Arkansas Veterans Healthcare System , Little Rock, AR
Little Rock, Arkansas, 72205, United States
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211, United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770, United States
Boise VA Medical Center, Boise, ID
Boise, Idaho, 83702, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara Edmond, PhD
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
- PRINCIPAL INVESTIGATOR
Karen H Seal, MD MPH
San Francisco VA Medical Center, San Francisco, CA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcomes assessor will not know participant assignment at 1-, 3-, 6-, and 12-month assessments.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2025
First Posted
September 2, 2025
Study Start
November 20, 2025
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
October 1, 2029
Last Updated
April 2, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share