Pain Care at Home to Amplify Function (Pain CHAMP)

NCT ID: NCT05333341

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 259 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-16
• Study Completion Date: 2027-06-30

Brief Summary

This project aims to test simultaneously the effectiveness of telemedicine and collaborative management (TCM) vs. TCM plus Cooperative Pain Education and Self-Management (COPES) on patient level outcomes and the impact of site-tailored Implementation Facilitation to work toward long term opioid therapy dose reduction. Pain CHAMP is a patient-level randomized hybrid II effectiveness-implementation trial comparing TCM vs. TCM + COPES on the primary composite outcome of pain interference and OUD/misuse symptoms.

Detailed Description

Pain CHAMP is a patient-level randomized hybrid II effectiveness-implementation trial comparing TCM vs. TCM + COPES on the primary composite outcome of pain interference and OUD/misuse symptoms. The investigators have developed two evidence-based collaborative care interventions that use focused resources to assist primary care providers (PCPs) in meeting the two main challenges in managing care for patients on long-term opioid therapy (LTOT) with chronic pain (CP) and opioid use disorder (OUD)/misuse: 1) reassessment of LTOT and switch to medication for opioid use disorder (MOUD) as indicated and 2) ready access to evidence-based behavioral pain treatment. Both interventions are entirely virtual and thus serve the needs of many underserved populations. Telemedicine Collaborative Management (TCM) features clinical pharmacists leading LTOT reassessment and buprenorphine (BUP) initiation in consultation with a BUP-prescribing physician. The TCM model is effective in decreasing pain interference, achieving LTOT dose reduction, BUP initiation and continuation, and shows greater patient engagement than the more resource intensive Integrated Pain Team comparator arm. Cooperative Pain Education and Self-Management (COPES), a cognitive-behavioral therapy (CBT) program delivered via telehealth that improves pain interference, improves access to evidence-based behavioral pain treatment.

While TCM and COPES are established interventions, the additional value of COPES-as a behavioral CP intervention paired with the pharmacologic-focused TCM for chronic pain and LTOT misuse/OUD--has not been tested. To advance systems-level approaches to addressing co-occurring CP, LTOT and OUD/misuse, this study will make two important steps forward. First, the investigators will use a pragmatic approach and randomize at the site-level so all eligible patients will receive standard-of-care treatment. Second, the study will train PCPs in how to re-assume care of patients' post-collaborative care to maintain gains made during the intervention/s. To meet these goals, the team of investigators with expertise conducting high-impact CP and OUD research propose Pain Care at Home to Amplify Function (Pain CHAMP) a hybrid II trial to test simultaneously the effectiveness of TCM vs. TCM plus COPES on patient level outcomes and the impact of site-tailored Implementation Facilitation on successful uptake of each intervention with the following specific aims:

Aim 1: Compare the effectiveness of pharmacist-led TCM vs TCM plus COPES on the primary composite outcome of improved pain interference and opioid safety as measured by opioid misuse or opioid use disorder. As secondary outcomes, we will compare groups on alcohol use, anxiety, depression, and sleep.

Aim 2: Evaluate the effectiveness of Implementation Facilitation for TCM and COPES on Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) guided outcomes using mixed qualitative-quantitative methods.

Aim 3: Examine the cost-effectiveness of TCM plus COPES, relative to TCM, on the primary composite outcome.

This study receives support from and included in the HEAL Initiative (https://heal.nih.gov/).

Conditions

Opioid Use Disorder; Opioid Misuse; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TCM

TCM uses clinical pharmacists leading LTOT reassessment and, when indicated for underlying OUD, buprenorphine (BUP) initiation in consultation with a BUP-prescribing physician. Clinical pharmacists will lead LTOT reassessment and, when indicated for underlying OUD, buprenorphine (BUP) initiation in consultation with a BUP-prescribing physician.

Group Type: ACTIVE_COMPARATOR

TCM

Intervention Type: BEHAVIORAL

TCM care is remotely-delivered and medium-term (up to 12 months), with the objective of improving CP and OUD/misuse symptoms primarily through medication management.

TCM plus COPES

Participants in this arm will use TCM plus COPES that will augment the effectiveness of TCM alone.

Group Type: EXPERIMENTAL

TCM plus COPES

Intervention Type: BEHAVIORAL

The COPES program will augment the effectiveness of TCM alone. COPES is a 12-week, Interactive Voice Response (IVR)-facilitated program of CBT for CP and common sequelae (depressive symptoms, sleep difficulties, low physical activity). Ongoing COPES engagement will be tracked by the COPES system. The primary components of the intervention are: 1) a self-help handbook containing the rationale and instructions for using ten pain self-management skills and their corresponding weekly skill practice goals; 2) a pedometer-facilitated walking program; 3) daily, automated IVR calls to collect pain interference, sleep quality, pedometer-measured step count, and adherence to the pain coping skill practice ratings; and 4) weekly, two to four minute pre-recorded, personalized therapist messages based on participant IVR-reported data.

Interventions

TCM

TCM care is remotely-delivered and medium-term (up to 12 months), with the objective of improving CP and OUD/misuse symptoms primarily through medication management.

Intervention Type: BEHAVIORAL

TCM plus COPES

The COPES program will augment the effectiveness of TCM alone. COPES is a 12-week, Interactive Voice Response (IVR)-facilitated program of CBT for CP and common sequelae (depressive symptoms, sleep difficulties, low physical activity). Ongoing COPES engagement will be tracked by the COPES system. The primary components of the intervention are: 1) a self-help handbook containing the rationale and instructions for using ten pain self-management skills and their corresponding weekly skill practice goals; 2) a pedometer-facilitated walking program; 3) daily, automated IVR calls to collect pain interference, sleep quality, pedometer-measured step count, and adherence to the pain coping skill practice ratings; and 4) weekly, two to four minute pre-recorded, personalized therapist messages based on participant IVR-reported data.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Participants:

• Engaged in TCM intervention (with or without COPES)

Providers:

• Engaged with a participating study site

Exclusion Criteria

Participants:

• Not engaged in TCM intervention

Providers:

• Not engaged with a participating study site

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Becker, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Little Rock VAMC

Little Rock, Arkansas, United States

Eastern Colorado HCS

Aurora, Colorado, United States

VA Connecticut HCS

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

1RM1DA055310-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000031092

Identifier Type: -

Identifier Source: org_study_id