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Tailored Non-Pharmacotherapy Services for Chronic Pain (RESOLVE)

Primary Purpose

Chronic Pain

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Online CBT-CP based program

Virtual coach-led CBT-CP based program

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring nonpharmacologic treatment, cognitive behavioral therapy, telehealth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kaiser Permanente Georgia, Center for Research and Evaluation
Essentia Institute of Rural Health
Kaiser Permanente Northwest Center for Health Research
Kaiser Permanente Washington Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

Online CBT-CP based program

Virtual coach-led CBT-CP based program

Usual Care plus information

Arm Description

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)

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)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Achieving MCID in pain severity at 6 and 12 months (yes / no)

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)

Pain intensity

Pain intensity subscale of modified version of BPI-SF (4 items; continuous). Range: 0 to 10. Higher score - worse pain-related intensity.

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.

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.

Physical functioning

PROMIS Physical Functioning Short Form 6b (6 items; continuous). Range: 0 to 6. Higher score = better physical functioning.

Patient global impression of change (PGIC)

Guy/Farrar Patient Global Impression of Change (1 item). Range: 0 to 6. High score = worse outcome.

Full Information

NCT ID

NCT04523714

First Posted

August 19, 2020

Last Updated

August 24, 2023

Sponsor

Kaiser Permanente

Collaborators

Essentia Health, Georgia State University, Duke University, Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT04523714

Brief Title

Tailored Non-Pharmacotherapy Services for Chronic Pain

Acronym

RESOLVE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 14, 2021 (Actual)

Primary Completion Date

April 30, 2024 (Anticipated)

Study Completion Date

August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kaiser Permanente

Collaborators

Essentia Health, Georgia State University, Duke University, Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

Keywords

nonpharmacologic treatment, cognitive behavioral therapy, telehealth

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The study uses a 3-arm, parallel intervention design; both intervention arms will be compared to usual care services.

Masking

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.

Allocation

Randomized

Enrollment

2333 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Online CBT-CP based program

Arm Type

Active Comparator

Arm Description

Arm Title

Virtual coach-led CBT-CP based program

Arm Type

Active Comparator

Arm Description

Arm Title

Usual Care plus information

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Online CBT-CP based program

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Virtual coach-led CBT-CP based program

Intervention Description

Primary Outcome Measure Information:

Title

Achieving minimal clinically important difference (MCID) in pain severity at 3 months (yes/no)

Description

Time Frame

Baseline to 3 months

Secondary Outcome Measure Information:

Title

Cost and incremental cost-effectiveness

Description

Time Frame

Patient health care utilization costs from baseline to 12 months

Title

Achieving MCID in pain severity at 6 and 12 months (yes / no)

Description

Time Frame

Baseline to 6 and 12 months

Title

Pain severity

Description

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)

Time Frame

Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months

Title

Pain intensity

Description

Pain intensity subscale of modified version of BPI-SF (4 items; continuous). Range: 0 to 10. Higher score - worse pain-related intensity.

Time Frame

Baseline to 3, 6, and 12 months

Title

Pain-related interference

Description

Pain-related interference subscale of modified version of BPI-SF (7 items, continuous). Range: 0 to 10. Higher score = worse pain-related interference.

Time Frame

Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months

Title

Social role functioning

Description

Time Frame

Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months

Title

Physical functioning

Description

PROMIS Physical Functioning Short Form 6b (6 items; continuous). Range: 0 to 6. Higher score = better physical functioning.

Time Frame

Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months

Title

Patient global impression of change (PGIC)

Description

Guy/Farrar Patient Global Impression of Change (1 item). Range: 0 to 6. High score = worse outcome.

Time Frame

Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lynn L DeBar, PhD, MPH

Organizational Affiliation

Kaiser Permanente

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaiser Permanente Georgia, Center for Research and Evaluation

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30309

Country

United States

Facility Name

Essentia Institute of Rural Health

City

Duluth

State/Province

Minnesota

ZIP/Postal Code

55805

Country

United States

Facility Name

Kaiser Permanente Northwest Center for Health Research

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

Facility Name

Kaiser Permanente Washington Health Research Institute

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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).

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Tailored Non-Pharmacotherapy Services for Chronic Pain

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