Tailored Non-Pharmacotherapy Services for Chronic Pain (RESOLVE)

• ClinicalTrials.gov Identifier: NCT04523714
• Recruitment Status: Active, not recruiting
• First Posted: August 24, 2020
• Last Update Posted: August 28, 2023
• Sponsor: Kaiser Permanente
• Collaborators: Essentia Health; Georgia State University; Duke University; Northwestern University
• Information provided by (Responsible Party): Kaiser Permanente

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Chronic Pain	Behavioral: Online CBT-CP based program; Behavioral: Virtual coach-led CBT-CP based program	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2333 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The study uses a 3-arm, parallel intervention design; both intervention arms will be compared to usual care services.
• Masking: Single (Outcomes Assessor)
• Masking Description: Primary and secondary outcome assessors will be masked to treatment assignment. It is not feasible for participants to be masked to treatment arm assignment due to the type of intervention. The PI and select Co-Investigators and study staff who are involved in the oversight and delivery of the interventions will also be aware of treatment assignment.
• Primary Purpose: Treatment
• Official Title: Tailored Non-Pharmacotherapy Services for Chronic Pain: Testing Scalable and Pragmatic Approaches
• Actual Study Start Date: January 14, 2021
• Estimated Primary Completion Date: April 30, 2024
• Estimated Study Completion Date: August 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Achieving minimal clinically important difference (MCID) in pain severity at 3 months (yes/no) [ Time Frame: Baseline to 3 months ]
   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.

Secondary Outcome Measures :

1. Cost and incremental cost-effectiveness [ Time Frame: Patient health care utilization costs from baseline to 12 months ]

   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.

2. Achieving MCID in pain severity at 6 and 12 months (yes / no) [ Time Frame: Baseline to 6 and 12 months ]
   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)
3. Pain severity [ Time Frame: Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months ]
   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)
4. Pain intensity [ Time Frame: Baseline to 3, 6, and 12 months ]
   Pain intensity subscale of modified version of BPI-SF (4 items; continuous). Range: 0 to 10. Higher score - worse pain-related intensity.
5. Pain-related interference [ Time Frame: Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months ]
   Pain-related interference subscale of modified version of BPI-SF (7 items, continuous). Range: 0 to 10. Higher score = worse pain-related interference.
6. Social role functioning [ Time Frame: Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months ]
   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.
7. Physical functioning [ Time Frame: Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months ]
   PROMIS Physical Functioning Short Form 6b (6 items; continuous). Range: 0 to 6. Higher score = better physical functioning.
8. Patient global impression of change (PGIC) [ Time Frame: Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months ]
   Guy/Farrar Patient Global Impression of Change (1 item). Range: 0 to 6. High score = worse outcome.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Georgia

Kaiser Permanente Georgia, Center for Research and Evaluation

Atlanta, Georgia, United States, 30309

United States, Minnesota

Essentia Institute of Rural Health

Duluth, Minnesota, United States, 55805

United States, Oregon

Kaiser Permanente Northwest Center for Health Research

Portland, Oregon, United States, 97227

United States, Washington

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, United States, 98101

Sponsors and Collaborators

Kaiser Permanente

Essentia Health

Georgia State University

Duke University

Northwestern University

Investigators

• Principal Investigator: Lynn L DeBar, PhD, MPH; Kaiser Permanente

More Information

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT04523714
• Other Study ID Numbers: 192317
• First Posted: August 24, 2020
• Last Update Posted: August 28, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol
• 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).
• 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).

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kaiser Permanente:

nonpharmacologic treatment; cognitive behavioral therapy; telehealth

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations