Study Protocol for a Pain Self-Management Intervention to Reduce Pain and Improve MOUD Engagement in Primary Care: A Randomized Trial

Individuals with opioid misuse (OM) or opioid use disorder (OUD) frequently have co-occurring chronic pain (CP). Services for these chronic conditions are commonly siloed in specialty treatment programs with few empirically demonstrated integrated interventions for patients with OM/OUD+CP. This manuscript describes the Tailored Retention and Engagement for Effective-integrated Treatment of OUD and Pain (TREETOP) engagement clinical trial protocol testing the effectiveness of a pain self-management (PSM) intervention at improving outcomes for patients with OM/OUD+CP in the context of primary care settings. This is a multisite hybrid type-1 effectiveness-implementation clinical trial (n = 228) wherein stratified equal randomization is used to assign participants to either PSM or usual care. The PSM intervention is novel because it was tailored to patients with OM/OUD+CP and is delivered remotely by a trained interventionist over ten 1-hour sessions. All study activities are conducted virtually, and follow-up study visits occur at 3-, 6- and 9-months. Enhanced technology-based recruitment strategies are used to boost accrual. The primary outcome is reduction in pain interference (PROMIS SF v1.0—Pain Interference 4a) at 3-months and secondary outcomes include pain self-efficacy (PSEQ), medications for opioid use disorder engagement and illicit drug use (Modified ASI). The supplemental protocol provides in-depth information on the study design and methods. Implementation measures are specific to this trial, which are crucial for the understanding and advancement of the uptake of evidence-based practices into everyday care. As part of the HEAL initiative^® funded Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR) network, this randomized controlled trial will determine the effectiveness of an integrated PSM intervention for patients with OM/OUD+CP, which has the potential to broadly reach under-served populations given its remote delivery and linkage with primary care settings.