Tailored Non-Pharmacotherapy Services for Chronic Pain (RESOLVE)

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Online CBT-CP based program; Behavioral: Virtual coach-led CBT-CP based program

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 2333
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Kaiser Permanente Georgia, Center for Research and Evaluation
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Essentia Institute of Rural Health
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Northwest Center for Health Research
  • Washington
    • Seattle, Washington, United States, 98101
      • Kaiser Permanente Washington Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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 (no usual care services restricted)	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
Active Comparator: 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 (no usual care services restricted)	Behavioral: 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
No Intervention: Usual Care plus information; 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?

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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Northwestern University; Duke University; Essentia Health; Georgia State University
• Investigators: Principal Investigator: Lynn L DeBar, PhD, MPH, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 24, 2020

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: cognitive behavioral therapy; telehealth; nonpharmacologic treatment
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 192317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A releasable database containing underlying Individual Participant Data (IPD) from the primary outcomes manuscript and all National Institutes of Health (NIH) HEAL (Helping to End Addiction Long-term) Initiative common data elements will be produced and made broadly available through the NIH HEAL Initiative-designated central data repository. The database will be completely de-identified in accordance with the definitions provided in the Health Insurance Portability and Accountability Act (HIPAA) and in accordance to the standards set forth in the Department of Health and Human Services Regulations for the Protection of Human Subjects. Namely, all identifiers specified in HIPAA will be recoded in a manner that will make it impossible to deduce or impute the specific identity of any patient. The database will not contain any institutional or healthcare system identifiers.
• IPD Sharing Time Frame: The database will be released at the time of publication of the primary manuscript, or within 12 months of last patient procedure, whichever comes first. The duration of availability will be in accordance with procedures and regulations of the NIH HEAL Initiative and the project funder (NIA).
• IPD Sharing Access Criteria: Access to the releasable database housed in the NIH-assigned repository will be in accordance with procedures and regulations of the NIH HEAL Initiative and the project funder (NIA).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No