Pain Care at Home to Amplify Function (Pain CHAMP)

NCT05333341 | Active Not Recruiting DMC

• 2 other identifiers: 20000310921RM1DA055310-01
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 3

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.

Conditions

Opioid Use Disorder; Opioid Misuse; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving improvement in pain interference with no evidence of OUD or misuse

  Proportion of participants achieving both improvement in pain interference by using ≥ 1 point improvement in pain interference as measured by the PEG-3 scale and no evidence of OUD or misuse (score 0 on TAPS-2 opioid items and medical chart review shows no evidence).

  10 months

Secondary Outcomes (4)

• Mean change in anxiety using the Generalized Anxiety Disorder-2 (GAD-2) questionnaire

  10 months

• Mean change in depression assessed using Patient Health Questionnaire-2 (PHQ-2)

  10 months

• Proportion of participants with high-risk alcohol use assessed using Alcohol Use Disorders Identification Test-C (AUDIT-C)

  10 months

• Mean change in sleep assessed using Brief Pain Inventory (BPI) sleep item

  10 months

Other Outcomes (5)

• Proportion of participants that initiate COPES

  End of TCM implementation (approximately 30 months after start)

• Proportion of participants on a TCM panel that achieve BUP stabilization

  12 months

• Proportion of PCP at each site that prescribed buprenorphine during the study period

  End of TCM implementation (approximately 30 months after start)

Study Arms (2)

TCM

ACTIVE COMPARATOR

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.

Behavioral: TCM

TCM plus COPES

EXPERIMENTAL

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

Behavioral: TCM plus COPES

Interventions

TCM 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

TCM plus COPES 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.

TCM plus COPES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants:
• Engaged in TCM intervention (with or without COPES)
• Providers:
• Engaged with a participating study site

You may not qualify if:

• Participants:
• Not engaged in TCM intervention
• Providers:
• Not engaged with a participating study site

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Little Rock VAMC

Little Rock, Arkansas, 72205, United States

Location

Eastern Colorado HCS

Aurora, Colorado, 80045, United States

Location

VA Connecticut HCS

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William Becker, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 19, 2022
• Study Start: June 16, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (3)