NCT07149870 · VA Office of Research and Development
Pain Management Teams Using Whole Health to Optimize Function and Safety in Veterans: The TEAMWORK Trial
(TEAMWORK)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
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 8-12 coaching sessions over approximately 5 months.
OTHER
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).
Primary outcome measures
Composite of Pain Interference and Opioid Safety
Time frame: 6 months
The primary outcome is a composite of pain-related interference and opioid safety. Success is met when pain-related interference and opioid safety improve. The pain component of the primary outcome is change in pain interference from baseline, measured on the Brief Pain Inventory, categorized as improved/not improved; where improvement: ≥1 point reduction in pain-related interference. The opioid safety component is defined as success in ≥1 of the following: (1) initiating and continuing buprenorphine for ≥ 90 days, (2) evidence of opioid taper ( \>25% reduction in daily full agonist opioid dose, including opioid discontinuation), (3) \>25% reduction in dose of benzodiazepine, gabapentin, pregabalin, nonbenzodiazepine hypnotic agents/sedative hypnotics, or skeletal muscle relaxant, (4) resolution of a positive baseline TAPS-2 score, (5) resolution of a positive AUDIT-C score, or (6) reduction in opioid-related difficulties as measured by the Prescribed Opioids Difficulties scale.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Birmingham, Alabama
- Little Rock, Arkansas
- Aurora, Colorado
- West Haven, Connecticut
- Boise, Idaho
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 17, 2026 · Source of record for eligibility and locations