Pain Care at Home to Amplify Function (Pain CHAMP)

Opioid Use Disorder Clinical Trial

Official title: Pain Care at Home to Amplify Function (Pain CHAMP)

Status Recruiting

Clinical Trial 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 cluster-randomized hybrid II effectiveness-implementation trial comparing TCM vs. TCM + COPES on the primary composite outcome of pain interference and OUD/misuse symptoms.

Clinical Trial Description

Pain CHAMP is a cluster-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 outcome pain interference. As secondary outcomes, we will compare groups on opioid safety measured by OUD/misuse symptoms, 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.

Targeted numbers of participants are:

Developmental formative evaluation interviews:

• participants: 48

• pharmacists and physicians: 32

• peer support specialists: 32

• primary care providers: 48

• clinic directors and hospital administrators: max 32

Implementation-focused Formative Evaluation:

• participants: 48

• pharmacists and physicians: 32

• peer support specialists: max 32

• primary care providers: 48

• clinic directors and hospital administrators: 32 ;

Related Conditions & MeSH terms

• Opioid Misuse
• Opioid Use Disorder
• Opioid-Related Disorders

• NCT number: NCT05333341
• Study type: Interventional
• Source: Yale University
• Contact: Maria Zenoni, MS
• Phone: 203-932-5711
• Email: maria.zenoni@va.gov
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2023
• Completion date: December 15, 2027