Pain Management Teams Using Whole Health to Optimize Function and Safety in Veterans: The TEAMWORK Trial
NCT ID: NCT07149870
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
432 participants
INTERVENTIONAL
2025-11-20
2029-10-01
Brief Summary
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Detailed Description
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The primary study goal is to evaluate the effectiveness of adding Whole Health Coaching to PMTs adhering to VA standards on the primary composite outcome of pain-related function and opioid safety, and secondary outcomes of wellbeing and physical functioning. Participants will have a 50/50 random chance of being assigned to (a) continuing to receive usual care from the PMT or (b) (a) receiving WHC in addition to the usual care provided by the PMT.
Both groups will receive usual care from the PMT, which will include a baseline evaluation with at least two PMT clinicians. Follow-up appointments will vary based on clinical judgment of the PMT members, but most patients will be followed for at least six months with at least three follow-up appointments. Both groups will complete questionnaires via telephone at (1) baseline, (2) month 1, (3) month 3, (4) month 6, and (5) month 12. The questionnaires will ask about personal characteristics and demographics, pain, physical function, ability to do activities, social support, sleep, mental health, use of medications and health services, and substance use.
If assigned to participate in PMT-WHC, participants will work with a Whole Health Coach for eight (8) individual sessions. Whole Health Coaching begins by completing a Personalized Health Inventory (PHI), where progress is assessed within eight (8) dimensions of health and wellness: Physical, Emotional, Social, Spiritual, Intellectual, Environmental, Financial, and Occupational health. The Inventory culminates in defining personal values and overall goals for health and wellness (i.e., "What do you want your health for?") based on a person's mission, aspiration, and purpose. This will be used to create goals that become part of a Personal Health Plan. The Personal Health Plan emphasizes self-management strategies to manage pain. After the Plan is developed, ongoing support is provided from the Coach in coaching sessions. Coaches will meet with participants on a biweekly basis for the first three (3) months after randomization and on a monthly basis for the final two (2) months, for a total of eight (8) sessions across approximately five (5) months. The sessions with the WHC will be recorded (audio recordings only, no photographs or video recordings). However, participation is still available in this study if participants decline to be recorded.
Participants may also be selected to participate in a qualitative interview. If selected, the interview covers participant experiences and opinions about working with the PMT, and, if relevant, the WHC. This interview will be recorded and will be approximately 60 minutes. Participants are not required to complete the interview and are still eligible to participate in this research study if the interview portion is declined.
The study will also evaluate implementation facilitation as a strategy to support PMTs in implementing care for patients with pain and opioid safety concerns. Implementation facilitation will include audit and feedback and other strategies tailored to each site. A budget impact analysis will monitor implementation and intervention costs.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
The intervention model adds to the existing approach by enhancing Pain management teams (PMTs) with Whole Health coaching. Coaches use the VA Whole Health Personalized Health Planning and Coaching approach to promote wellness in Veterans with chronic pain.
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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PMT-WHC
The PMT-WHC group will receive PMT Usual Care plus 8 sessions of Whole Health Coaching (WHC)
Pain 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.
Pain 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).
PMT-UC
The PMT-UC group will receive PMT Usual Care
Pain 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).
Interventions
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Pain 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.
Pain 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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
-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
-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.
18 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Sara Edmond, PhD
Role: PRINCIPAL_INVESTIGATOR
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Karen H Seal, MD MPH
Role: PRINCIPAL_INVESTIGATOR
San Francisco VA Medical Center, San Francisco, CA
Locations
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Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States
Central Arkansas Veterans Healthcare System , Little Rock, AR
Little Rock, Arkansas, United States
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States
Boise VA Medical Center, Boise, ID
Boise, Idaho, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1UG3AT012256-01A1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SDR 24-122
Identifier Type: -
Identifier Source: org_study_id
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