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.
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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
432
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) 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).
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States
RECRUITINGCentral Arkansas Veterans Healthcare System , Little Rock, AR
Little Rock, Arkansas, United States
WITHDRAWNRocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States
Composite of Pain Interference and Opioid Safety
The primary outcome for the clinical trial is a composite of pain-related interference and opioid safety where success at the individual level is only met when pain-related interference and opioid safety improve. The pain component of the composite primary outcome, measured at 6-month follow-up, will be change in pain interference from baseline, measured on the Brief Pain Inventory - Interference scale, categorized as improved/not improved with improvement defined as a ≥1 point reduction in pain-related interference. The opioid safety component of the composite primary outcome will be defined as success in one or more of the following: (1) initiating and continuing buprenorphine for at least 90 days, or (2) evidence of an opioid taper (i.e., a \>25% reduction in daily full agonist opioid dose, including opioid discontinuation), at 6 months.
Time frame: 6 months
Opioid Safety
We will look at a more expansive list of indicators of improved opioid safety as a secondary outcome, including: (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), (3) 25% reduction in gabapentin dose, (4) 25% reduction in benzodiazepine dose, (5) resolution of a positive baseline TAPS-2 score, (6) resolution of a positive AUDIT-C score, (7) reduction in opioid-related difficulties as measured by the Prescribed Opioids Difficulties (PODS) scale, and (8) reductions in sleepiness as measured by the Epworth Sleepiness Scale.
Time frame: 6 months, 12 months
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.
Time frame: 6 months, 12 months
Pain Interference
The pain component of the composite primary outcome, measured at 6-month follow-up, will be change in pain interference from baseline, measured on the Brief Pain Inventory - Interference scale, categorized as improved/not improved with improvement defined as a ≥1 point reduction in pain-related interference.
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VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States
RECRUITINGBoise VA Medical Center, Boise, ID
Boise, Idaho, United States
RECRUITINGTime frame: 6 months, 12 months
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).
Time frame: 6 months, 12 months
Composite of Pain Interference and Opioid Safety
We will examine the composite of pain-related interference and opioid safety (primary outcome at 6 months) as a secondary outcome for durability of effects at 12 months. The pain component of the composite primary outcome, measured at 12-month follow-up, will be change in pain interference from baseline, measured on the Brief Pain Inventory - Interference scale, categorized as improved/not improved with improvement defined as a ≥1 point reduction in pain-related interference. The opioid safety component of the composite primary outcome will be defined as success in one or more of the following: (1) initiating and continuing buprenorphine for at least 90 days, or (2) evidence of an opioid taper (i.e., a \>25% reduction in daily full agonist opioid dose, including opioid discontinuation), at 12 months.
Time frame: 12 months