Collaborative care in the treatment of opioid use disorder and mental health conditions in primary care: A clinical study protocol

Abstract

Background: People with opioid use disorder (OUD) often have a co-occurring psychiatric disorder, which elevates the risk of morbidity and mortality. Promising evidence supports the use of collaborative care for treating people with OUD in primary care. Whether collaborative care interventions that treat both OUD and psychiatric disorders will result in better outcomes is presently unknown.

Methods: The Whole Health Study is a 3-arm randomized controlled trial designed to test collaborative care treatment for OUD and the psychiatric disorders that commonly accompany OUD. Approximately 1200 primary care patients aged ≥18 years with OUD and depression, anxiety, or PTSD will be randomized to one of three conditions: (1) Augmented Usual Care, which consists of a primary care physician (PCP) waivered to prescribe buprenorphine and an addiction psychiatrist to consult on medication-assisted treatment; (2) Collaborative Care, which consists of a waivered PCP, a mental health care manager trained in psychosocial treatments for OUD and psychiatric disorders, and an addiction psychiatrist who provides consultation for OUD and mental health; or (3) Collaborative Care Plus, which consists of all the elements of the Collaborative Care arm plus a Certified Recovery Specialist to help with treatment engagement and retention. Primary outcomes are six-month rates of opioid use and six-month rates of remission of co-occurring psychiatric disorders.

Discussion: The Whole Health Study will investigate whether collaborative care models that address OUD and co-occurring depression, anxiety, or PTSD will result in better patient outcomes. The results will inform clinical care delivery during the current opioid crisis.

Clinical trials registration: www.clinicaltrials.gov registration: NCT04245423.

Keywords: Clinical protocol; Collaborative care; Medication-assisted treatment; Mental health disorder; Opioid use disorder; Primary care; Randomized controlled trial.

Conflict of interest statement

Conflict of Interest

All investigators will follow the University of Pennsylvania Policy on Conflicts of Interest Related to Research.

Copyright © 2021 Elsevier Inc. All rights reserved.

Figures

Figure 1.

RCT study protocol for the Whole Health Study Abbreviations: AUC, augmented usual care; CC, collaborative care; CC+, collaborative care plus; C− SSRS, Columbia Suicide Severity Rating Scale; DSM-5, Diagnostic and Statistical Manual of Mental Disorders, 5th edition; GAD-7, General Anxiety Disorder-7 scale; MAT, medication-assisted treatment; OUD, opioid use disorder; PC-PTSD, Primary Care PTSD Screen; PCL-5, Posttraumatic Stress Disorder Checklist; PCP, primary care physician; PHQ-9, Patient Health Questionnaire-9; RCT, randomized controlled trial