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

Обзор

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.

Подробное описание

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) (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 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.

Вмешательства

• Другое 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 coac
• Другое 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 me

Первичные конечные точки

• Composite of Pain Interference and Opioid Safety [Срок оценки: 6 months]

Вторичные конечные точки (5)

• Opioid Safety [Срок оценки: 6 months, 12 months]
• Well-Being Signs (WBS) Tool [Срок оценки: 6 months, 12 months]
• Pain Interference [Срок оценки: 6 months, 12 months]
• Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form 6b [Срок оценки: 6 months, 12 months]
• Composite of Pain Interference and Opioid Safety [Срок оценки: 12 months]

Критерии участия

Критерии включения

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 5 центров

• Birmingham VA Medical Center, Birmingham, AL — Birmingham
• Central Arkansas Veterans Healthcare System , Little Rock, AR — Little Rock
• Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora
• VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven
• Boise VA Medical Center, Boise, ID — Boise

Идентификаторы

NCT: NCT07149870 · SDR 24-122 · 1UG3AT012256-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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