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Status:

ACTIVE_NOT_RECRUITING

Tailored Non-Pharmacotherapy Services for Chronic Pain

Lead Sponsor:

Kaiser Permanente

Collaborating Sponsors:

Essentia Health

Georgia State University

Conditions:

Chronic Pain

Eligibility:

All Genders

18+ years

Phase:

NA

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...

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 pat...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 14 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 31 2025

    Estimated Enrollment :

    2333 Patients enrolled

    Trial Details

    Trial ID

    NCT04523714

    Start Date

    January 14 2021

    End Date

    August 31 2025

    Last Update

    September 19 2024

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Kaiser Permanente Georgia, Center for Research and Evaluation

    Atlanta, Georgia, United States, 30309

    2

    Essentia Institute of Rural Health

    Duluth, Minnesota, United States, 55805

    3

    Kaiser Permanente Northwest Center for Health Research

    Portland, Oregon, United States, 97227

    4

    Kaiser Permanente Washington Health Research Institute

    Seattle, Washington, United States, 98101