Clinical trial NCT04523714: Tailored Non-Pharmacotherapy Services for Chronic Pain
Official title: Tailored Non-Pharmacotherapy Services for Chronic Pain: Testing Scalable and Pragmatic Approaches
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: nonpharmacologic treatment
cognitive behavioral therapy
telehealth
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Essentia Health
name: Georgia State University
name: Duke University
name: Northwestern University
First posted: 2020-08-24
Enrollment: 2333
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study uses a 3-arm, parallel intervention design; both intervention arms will be compared to usual care services.
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Achieving minimal clinically important difference (MCID) in pain severity at 3 months (yes/no)
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Cost and incremental cost-effectiveness
timeFrame: Patient health care utilization costs from baseline to 12 months
measure: Achieving MCID in pain severity at 6 and 12 months (yes / no)
timeFrame: Baseline to 6 and 12 months
measure: Pain severity
timeFrame: Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months
measure: Pain intensity
timeFrame: Baseline to 3, 6, and 12 months
measure: Pain-related interference
timeFrame: Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months
measure: Social role functioning
timeFrame: Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months
measure: Physical functioning
timeFrame: Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months
measure: Patient global impression of change (PGIC)
timeFrame: Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Kaiser Permanente Georgia, Center for Research and Evaluation
state: Georgia
city: Duluth
country: United States
facility: Essentia Institute of Rural Health
state: Minnesota
city: Portland
country: United States
facility: Kaiser Permanente Northwest Center for Health Research
state: Oregon
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Lynn L DeBar, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: