Clinical trial NCT05333341: Pain Care at Home to Amplify Function (Pain CHAMP)
Official title: Pain Care at Home to Amplify Function (Pain CHAMP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Opioid Misuse
Chronic Pain
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-04-19
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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

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

Primary outcomes:
measure: Proportion of participants on a TCM panel that achieve BUP stabilization
timeFrame: 12 months
measure: Proportion of participants that initiate COPES
timeFrame: 16 weeks and 10 months
measure: Proportion of participants achieving improvement in pain interference with OUD resolution
timeFrame: 16 weeks and 10 months
Secondary outcomes:
measure: Mean change in anxiety using the Generalized Anxiety Disorder-2 (GAD-2) questionnaire
timeFrame: 16 weeks and 10 months
measure: Mean change in depression assessed using Patient Health Questionnaire-2 (PHQ-2)
timeFrame: 16 weeks and 10 months
measure: Mean change in alcohol use assessed using Alcohol Use Disorders Identification Test-C (AUDIT-C)
timeFrame: 16 weeks and 10 months
measure: Mean change in sleep assessed using Brief Pain Inventory (BPI) -sleep item
timeFrame: 16 weeks and 10 months
measure: Proportion of PCP at each site eligible to prescribe buprenorphine
timeFrame: End of TCM implementation (approximately 30 months after start)
measure: Proportion of PCP at each site that prescribed buprenorphine during the study period
timeFrame: End of TCM implementation (approximately 30 months after start)
measure: Proportion of patient encounters in which ≥1 TCM components were implemented by providers to assess implementation of intervention
timeFrame: End of TCM implementation (approximately 30 months after start)
measure: Proportion of patient encounters in which individual TCM components were implemented over the intervention period
timeFrame: End of TCM implementation (approximately 30 months after start)
measure: Maintenance of medication management for ≥1 patients post-implementation
timeFrame: 6 months post TCM implementation
measure: Maintenance of referral to COPES post-implementation
timeFrame: 6 months post TCM implementation
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Little Rock VAMC
state: Arkansas
city: Aurora
country: United States
facility: Eastern Colorado HCS
state: Colorado
city: West Haven
country: United States
facility: VA Connecticut HCS
state: Connecticut
Study officials:
affiliation: Yale University
name: William Becker, MD
role: PRINCIPAL_INVESTIGATOR
References: