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Chronic PainTEAMWORKNCT07149870

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

A study testing Pain Management Team + Whole Health Coach (PMT-WHC) in people with Chronic Pain, run by VA Office of Research and Development at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain
What is being tested?
Pain Management Team + Whole Health Coach (PMT-WHC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
432 participants
Where
5 sitesUnited States
Study dates
20 Nov 2025to 1 Oct 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • High-impact chronic pain (defined using the Graded Chronic Pain Scale - Revised).
  • Active prescription for long-term opioid therapy (LTOT; including full agonist and buprenorphine) (>90 days continuous prescription).
  • 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 full-agonist opioids including chronic pulmonary disease (e.g., emphysema, chronic bronchitis, asthma, or other breathing problems), sleep apnea, chronic kidney disease, chronic hepatitis or cirrhosis
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  • active high-risk co-prescriptions, including long-term benzodiazepine prescription, gabapentin or pregabalin, nonbenzodiazepine hypnotic agents or sedative hypnotics, or skeletal muscle relaxants
  • a positive TAPS or AUDIT-C score
  • reported score of >8 as measured by the Prescribed Opioids Difficulties Scale (PODS).

Who cannot join

  • Moderate to severe cognitive impairment as measured by the Blessed Orientation Memory Concentration (BOMC) screening tool.
  • Inability to read or understand English.
  • Severely impaired hearing or speech that would preclude participation in telephone interviews or appointments with the Whole Health Coach.
  • Terminal illness/disease with a prognosis of <12 months.
  • Planned move/relocation outside of the treatment areas of the participating enrolling study sites.
  • Participants actively working with a Whole Health Coach or who have worked with a Whole Health Coach in the 6-months prior to enrollment.
  • Major surgical procedure planned during the study treatment or follow-up period.
  • a recent suicide attempt, defined as documented and/or reported suicide attempt within 90 days of the screening date.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Danielle M Wesolowicz, PhD contact

(203) 932-5711

Danielle.Wesolowicz@va.gov

Deanna J Ternes, BS contact

(971) 404-1473

deanna.ternes@va.gov

5 sites in 1 country

United States5 sites, 4 recruiting
  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045-7211

    Joseph W Frank, MD MPH, (720) 857-2784, joseph.frank2@va.gov

    Charlotte C Nolan, MPA, (720) 857-5091, Charlotte.Nolan@va.gov

    Recruiting
  • Birmingham VA Medical Center, Birmingham, AL

    Birmingham, Alabama, 35233-1927

    Kiara Parker, PharmD, (205) 933-8101 ext. 337667, kiara.parker@va.gov

    Jennifer V Ibarra, MPH, (203) 932-5711 ext. 1063, jennifer.ibarra@va.gov

    Recruiting
  • Boise VA Medical Center, Boise, ID

    Boise, Idaho, 83702

    Joseph Ineck, ART@va.gov

    Isabella Jordan, BS, (206) 764-2388, isabella.jordan@va.gov

    Recruiting
  • Central Arkansas Veterans Healthcare System , Little Rock, AR

    Little Rock, Arkansas, 72205

    Withdrawn
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    West Haven, Connecticut, 06516-2770

    Rolanda Chandler, (203) 932-5711, rolanda.chandler@va.gov

    Sara Edmond, PhD

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

This multisite pragmatic effectiveness-implementation hybrid type 2 trial will randomize 432 patients to compare Pain Management Team - Usual Care (PMT-UC) vs. Pain Management Team Usual Care + Whole Health Coaching (PMT-WHC) on the primary composite outcome of pain-related interference and opioid safety. The investigators will also evaluate the impact of PMT-WHC on buprenorphine initiation and maintenance, evaluate implementation facilitation strategies for building and sustaining PMTs, and conduct a budget impact analysis.

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) 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 a minimum of eight (8) individual sessions, with the option to continue coaching for up to 12 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 minimum 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
Chronic Pain
Being tested
Pain Management Team + Whole Health Coach (PMT-WHC), Pain Management Team-Usual Care (PMT-UC)
Keywords
Opioid Use, Opioid Safety, Pain, Chronic Pain, Long-term Opioid Therapy, Pain Management, Opioid, Whole Health, Coaching, Whole Health Coaching, Pain, Chronic, Buprenorphine
Medical subject headings
Chronic Pain, Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain Management Team + Whole Health Coach (PMT-WHC)Other

    Also called 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.

  • Pain Management Team-Usual Care (PMT-UC)Other

    Also called 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).

Study groups in NCT07149870
Study groupRoleWhat they receive
PMT-WHCExperimentalThe PMT-WHC group will receive PMT Usual Care plus 8 sessions of Whole Health Coaching (WHC)
Receives: Other: Pain Management Team + Whole Health Coach (PMT-WHC); Other: Pain Management Team-Usual Care (PMT-UC)
PMT-UCActive comparatorThe PMT-UC group will receive PMT Usual Care
Receives: Other: Pain Management Team-Usual Care (PMT-UC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of Pain Interference and Opioid Safety

    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.

    Measured: 6 months

Secondary outcomes (5)
  1. Opioid Safety

    The investigators will evaluate improved opioid safety as a secondary outcome, whereby success (binary yes/no) is improvement in any of the following:

    1. initiating and continuing buprenorphine for at least 90 days
    2. evidence of an opioid taper (i.e., a >25% reduction in daily full agonist opioid dose, including opioid discontinuation), measured at the 6-month follow-up visit
    3. >25% reduction in dose of benzodiazepine, gabapentin, pregabalin, nonbenzodiazepine hypnotic agents or 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 (PODS) scale.

    Measured: 6 months, 12 months

  2. Well-Being Signs (WBS) Tool

    The Wellbeing Signs Tool is a three (3) item screening tool with items asking respondents to rate how well they are doing in their daily lives; higher scores indicated better wellbeing and life satisfaction.

    Measured: 6 months, 12 months

  3. Pain Interference - Brief Pain Inventory (BPI)- Interference scale

    The pain component of the composite primary outcome, measured at 6-month and 12-month follow-up, will be change in pain interference from baseline, measured on the Brief Pain Inventory - Interference scale, using 11-point scales ranging from 0 (no pan interference) to 10 (complete pain interference), with higher scores indicating a greater degree to which pain is disrupting quality of life, and categorized as improved/not improved with improvement defined as a ≥1 point reduction in pain-related interference.

    Measured: 6 months, 12 months

  4. Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form 6b

    Physical Functioning: An assessment of the impact of pain on several aspects of functioning, including social and emotional processes as well as physical function (e.g., how much did pain interfere with your day to day activities).

    Measured: 6 months, 12 months

  5. Composite of Pain Interference and Opioid Safety

    We will examine the composite of pain-related interference and opioid safety (primary outcome at 6 mo) as a secondary outcome for durability of effects at 12 mo. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2025
  2. Study start20 Nov 2025
  3. Primary completion1 Oct 2029 (estimated)
  4. Study completion1 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
The interventional component of this trial includes 2 arms: 1) Pain management team usual care; and 2) Pain management team usual care with a Whole Health coach. Participants are randomized 1:1 at the individual level. 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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
432 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07149870
Sponsor's protocol ID
SDR 24-122
Other IDs
1UG3AT012256-01A1
Acronym
TEAMWORK
Status last verified
Aug 2026
First submitted
6 Aug 2025
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Pain Management Team + Whole Health Coach (PMT-WHC) in people with Chronic Pain, run by VA Office of Research and Development at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Danielle M Wesolowicz, PhD ((203) 932-5711, Danielle.Wesolowicz@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of Pain Interference and Opioid Safety (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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TEAMWORK Clinical Trial NCT07149870 | AzTrials