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, health coach-led, virtual sessions (telephone and/or video conference).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,333
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
Live, health 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
Kaiser Permanente Georgia, Center for Research and Evaluation
Atlanta, Georgia, United States
Essentia Institute of Rural Health
Duluth, Minnesota, United States
Kaiser Permanente Northwest Center for Health Research
Portland, Oregon, United States
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, United States
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% or greater improvement in pain severity score. \[Pain severity score assessed via modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF) from baseline (consistent with IMMPACT guidelines). The BPI-SF range= 0 to 10; higher score = worse pain severity.\] MCID outcome is binary; reported as the adjusted percentage of participants with MCID (\> or =30% improvement) in pain severity.
Time frame: Baseline to 3 months
MCID in Pain Severity at 6 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) Minimal clinically important difference (MCID) in pain severity is defined as a 30% or greater improvement in pain severity score. \[Pain severity score assessed via modified 11-item version of the BPI-SF from baseline (consistent with IMMPACT guidelines). The BPI-SF range= 0 to 10; higher score = worse pain severity.\] MCID outcome is binary; reported as the adjusted percentage of participants with MCID (\> or =30% improvement) in pain severity.
Time frame: Baseline to 6 months
MCID in Pain Severity at 12 Months (Yes / No)
Minimal clinically important difference (MCID) in pain severity is defined as a 30% or greater improvement in pain severity score. \[Pain severity score assessed via modified 11-item version of the BPI-SF from baseline (consistent with IMMPACT guidelines). The BPI-SF range= 0 to 10; higher score = worse pain severity.\] MCID outcome is binary; reported as the adjusted percentage of participants with MCID (\> or =30% improvement) in pain severity.
Time frame: Baseline to 12 months
Pain Severity Score
Modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF). Score is calculated mean of all 11 items; range 0-10 with a higher score = worse pain severity
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Time frame: Baseline to 3, 6 and 12 months
Pain Intensity Score
4-item subscale of the Brief Pain Inventory - Short Form (BPI-SF). Score is calculated mean of all 4 items; range 0-10 with a higher score = worse pain intensity
Time frame: Baseline to 3, 6, and 12 months
Pain-related Interference Score
7-item subscale of the Brief Pain Inventory - Short Form (BPI-SF). Score is calculated mean of 7 items; range 0-10 with a higher score = worse pain-related interference
Time frame: Baseline to 3, 6 and 12 months
Social Role Functioning
PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a: Score by summing the 4 items (each item response 1-5) and then converting raw score to standardized T-score, using the HealthMeasures Scoring Service, with mean of 50 and standard deviation of 10. Higher T-score= better ability to participate in social roles and activities. Score ≤40 indicates moderate (40-30) to severe (\< 30) limitations in ability to participate.
Time frame: Baseline to 3, 6 and 12 months
Physical Functioning
PROMIS Physical Function - Short Form 6b: Score by summing the 6 items (each item response 1-5) and then converting raw score to standardized T-score, using the HealthMeasures Scoring Service, with mean of 50 and standard deviation of 10. Higher T-score= better physical functioning. Score ≤40 indicates moderate (40-30) to severe (\< 30) limitations in physical functioning.
Time frame: Baseline to 3, 6 and 12 months
Patient Global Impression of Change (PGIC) - Pain
One item assessing participant's perception of change in pain since start of study; range 1-7 (1=much better, 2=moderately better, 3=a little better, 4=No change, 5=a little worse, 6=moderately worse, 7=much worse). Higher score = worsening of pain
Time frame: Primary: Baseline to 3, 6 and 12 months
Patient Global Impression of Change (PGIC) - General
One item assessing participant's perception of change in overall status since start of study; range 1-7 (1=much better, 2=moderately better, 3=a little better, 4=No change, 5=a little worse, 6=moderately worse, 7=much worse). Higher score = worsening of overall status
Time frame: Baseline to 3, 6 and 12 months