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.