Tailored Non-Pharmacotherapy Services for Chronic Pain

Chronic Pain Clinical Trial

— RESOLVE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04523714
• Other study ID #: 192317
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 14, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: August 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2333
• Est. completion date: August 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Online CBT-CP based program
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
• Virtual coach-led CBT-CP based program
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

Locations

Country	Name	City	State
United States	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

Sponsors (5)

Lead Sponsor	Collaborator
Kaiser Permanente	Duke University, Essentia Health, Georgia State University, Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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