Chronic Pain
Conditions
Keywords
Opioid Use, Opioid Safety, Pain, Chronic Pain, Long-term Opioid Therapy, Pain Management, Opioid, Whole Health, Coaching, Whole Health Coaching, Pain, Chronic, Buprenorphine
Brief 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.
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.
Interventions
OTHERPain 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.
OTHERPain 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).
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor will not know participant assignment at 1-, 3-, 6-, and 12-month assessments.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. High-impact chronic pain (defined using the Graded Chronic Pain Scale - Revised). 2. Active prescription for long-term opioid therapy (LTOT; including full agonist and buprenorphine) (\>90 days continuous prescription). 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 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 3. active high-risk co-prescriptions, including long-term benzodiazepine prescription, gabapentin or pregabalin, nonbenzodiazepine hypnotic agents or sedative hypnotics, or skeletal muscle relaxants 4. a positive TAPS or AUDIT-C score 5. reported score of \>8 as measured by the Prescribed Opioids Difficulties Scale (PODS).
Exclusion criteria
1. Moderate to severe cognitive impairment as measured by the Blessed Orientation Memory Concentration (BOMC) screening tool. 2. Inability to read or understand English. 3. Severely impaired hearing or speech that would preclude participation in telephone interviews or appointments with the Whole Health Coach. 4. Terminal illness/disease with a prognosis of \<12 months. 5. Planned move/relocation outside of the treatment areas of the participating enrolling study sites. 6. Participants actively working with a Whole Health Coach or who have worked with a Whole Health Coach in the 6-months prior to enrollment. 7. Major surgical procedure planned during the study treatment or follow-up period. 8. a recent suicide attempt, defined as documented and/or reported suicide attempt within 90 days of the screening date.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of Pain Interference and Opioid Safety | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Safety | 6 months, 12 months | 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. |
| Well-Being Signs (WBS) Tool | 6 months, 12 months | 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. |
| Pain Interference - Brief Pain Inventory (BPI)- Interference scale | 6 months, 12 months | 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. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form 6b | 6 months, 12 months | 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). |
| Composite of Pain Interference and Opioid Safety | 12 months | 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. |
Countries
United States
Contacts
CONTACTDanielle M Wesolowicz, PhD
CONTACTDeanna J Ternes, BS
PRINCIPAL_INVESTIGATORSara Edmond, PhD
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
PRINCIPAL_INVESTIGATORKaren H Seal, MD MPH
San Francisco VA Medical Center, San Francisco, CA
Outcome results
None listed