Tailored Non-Pharmacotherapy Services for Chronic Pain

Study Overview
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Brief Summary
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The RESOLVE study is a multicenter comparative effectiveness trial of two cognitive behavioral therapy-based chronic pain (CBT-CP) treatments delivered via telehealth modalities: 1) online program and 2) live, coach-led, virtual sessions (telephone and/or video conference).

Detailed Description
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Specific Aims Aim #1: Determine the effectiveness of an online, CBT-based pain management program and virtual coach-led (telephonic/video) CBT-CP on achieving clinically meaningful improvements in patients' pain severity (pain intensity + pain-related interference) relative to those receiving usual care at 3 months. 1a. Examine the impact of the active interventions on secondary pain outcomes and related quality of life outcomes (social role functioning, physical functioning, and patient global impression of change); as well as exploratory outcomes, which include long-term opioid use; comorbid symptomology (depression, anxiety, and sleep disturbance); and high impact chronic pain and graded chronic pain. 1b. Conduct subgroup analyses to determine the impact of the active interventions on specific populations and explore for potential heterogeneity of treatment effects by sex; rural/medically underserved residency; multiple pain conditions; mental health mood disorders; and negative social determinants of health. 1c. Examine the role of theory-based mediators, pain catastrophizing, pain-related self-efficacy, and perceived support, on pain-severity. Aim #2: Assess the cost and incremental cost-effectiveness of the online and virtual coach-led CBT-CP interventions compared to each other and usual care. Aim #3: Conduct a qualitative evaluation to understand: 1) patient experiences of the interventions, including how they relate to treatment response, variability by site, and rural/medically underserved residency status; and 2) health system issues, including adaptations and contextual factors at the site and external levels, barriers and facilitators to intervention success and potential for adoption, sustainability and dissemination.

Official Title
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Tailored Non-Pharmacotherapy Services for Chronic Pain: Testing Scalable and Pragmatic Approaches

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Online CBT-CP based program
* Behavioral: Virtual coach-led CBT-CP based program


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Electronic Health Record-based inclusion criteria: Active/enrolled in one of the 4 participating integrated health care systems at the time of query and for the prior 360 days Age 18 years or older (based on date of birth documented in EHR) English speaking or do not need interpreter services Have at least one [at Essentia] or at least two which are >60 days apart [at KP sites] outpatient pain-related health care encounter with nonmalignant musculoskeletal pain diagnoses [as determined by ICD10 codes for any of the following: back-neck-, limb/extremity-, joint-pain, arthritic disorders, fibromyalgia, headache, orofacial/temporomandibular pain, or musculoskeletal pain] within the past 360 days Do not have an encounter for surgery related to common musculoskeletal pain conditions (e.g., joint replacement, spinal fusion, carpal tunnel release surgery) [as determined by CPT and/or ICD-10 codes] within the past 60 days Do not have two or more separate encounters with a malignant cancer diagnosis other than non-melanoma skin cancer [as determined by ICD-10 codes] within past 60 days Do not have ICD-10 code(s), Current Procedural Terminology (CPT) code(s) or department/provider encounters indicating receipt of hospice or other palliative care within the past 360 days Do not have ICD-10 codes indicating severe cognitive impairment precluding participation in a behavioral/ lifestyle change program Note: At the KPWA site only, one additional EHR-based exclusion criterion will be applied, which is: Do not have ICD-10 codes indicating opioid use disorder (OUD). This criterion is being applied because there is another HEAL study being conducted at KPWA that focuses on treating individuals with pain and OUD specifically.] Patient-reported inclusion criteria: Have high-impact chronic pain (as indicated by self-report of having pain on most or every day in past 3 months and pain limiting life or work activities on most or every day in past 3 months) Have persistent pain (as indicated by self-report Pain, Enjoyment of Life and General Activity (PEG) score of ≥ 12) Be able to participate in either of the active interventions (i.e., have internet and phone access required for accessing treatments) EXCLUSION CRITERIA (patient-reported): Have received CBT for pain or pain-related psychoeducation or behavioral skills training within in the past 6 months (in-person, by phone or videoconference, or online) Currently receiving or will be starting CBT for pain or pain-related psychoeducation or behavioral skills training in the next month (in-person, by phone or videoconference, or online) Currently receiving or will be starting inpatient or intensive outpatient services for substance use disorder in the next month Have a planned/scheduled surgery in next 12 months related to pain condition

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study uses a 3-arm, parallel intervention design; both intervention arms will be compared to usual care services.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Online CBT-CP based program<br>Self-completed, online program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills (no usual care services restricted) | Behavioral: Online CBT-CP based program<br>* Self-completed, online program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills<br>|
| Active Comparator: Virtual coach-led CBT-CP based program<br>Live, coach-led program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills (no usual care services restricted) | Behavioral: Virtual coach-led CBT-CP based program<br>* Live, coach-led program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills<br>|
| No Intervention: Usual Care plus information<br>Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieving minimal clinically important difference (MCID) in pain severity at 3 months (yes/no) | Minimal clinically important difference (MCID) in pain severity is defined as a 30% decrease in score on modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF) from baseline (consistent with Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) guidelines) (binary). Range: 0 to 10. Higher score = worse pain severity. | Baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost and incremental cost-effectiveness | Health care utilization and intervention costs will be assessed. Using the framework of cost-effectiveness, we will estimate the incremental cost per additional patient with a MCID in pain severity (30% reduction from baseline), at 12 months, and the quality-adjusted life year (QALY) gained-utilities will be estimated using the EQ-5D-5L. | Patient health care utilization costs from baseline to 12 months | 
| Achieving MCID in pain severity at 6 and 12 months (yes / no) | Minimal clinically important difference (MCID) in pain severity is defined as a 30% decrease in score on modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF) from baseline (consistent with IMMPACT guidelines) (binary) | Baseline to 6 and 12 months | 
| Pain severity | Modified 11-item version of the Brief Pain Inventory - Short Form ( BPI-SF); composite of pain intensity (4 items) and pain-related interference (7 items) subscales (11 items total; continuous) | Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months | 
| Pain intensity | Pain intensity subscale of modified version of BPI-SF (4 items; continuous). Range: 0 to 10. Higher score - worse pain-related intensity. | Baseline to 3, 6, and 12 months | 
| Pain-related interference | Pain-related interference subscale of modified version of BPI-SF (7 items, continuous). Range: 0 to 10. Higher score = worse pain-related interference. | Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months | 
| Social role functioning | Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles 4A (4 items; continuous). Range: 4 to 20. Higher score = better ability to participate in social roles. | Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months | 
| Physical functioning | PROMIS Physical Functioning Short Form 6b (6 items; continuous). Range: 0 to 6. Higher score = better physical functioning. | Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months | 
| Patient global impression of change (PGIC) | Guy/Farrar Patient Global Impression of Change (1 item). Range: 0 to 6. High score = worse outcome. | Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nonpharmacologic treatment, cognitive behavioral therapy, telehealth