RecruitingNot ApplicableNCT07149870

Pain Management Teams Using Whole Health to Optimize Function and Safety in Veterans: The TEAMWORK Trial

Sponsor

VA Office of Research and Development

Enrollment

432 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Pain

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

Min Age: 18 Years

Inclusion Criteria13

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 Criteria15

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.

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Interventions

OTHERPain Management Team + Whole Health Coach (PMT-WHC)

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.

OTHERPain Management Team-Usual Care (PMT-UC)

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).