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. 2023 Apr:127:107124.
doi: 10.1016/j.cct.2023.107124. Epub 2023 Feb 18.

A patient-centered nurse-supported primary care-based collaborative care program to treat opioid use disorder and depression: Design and protocol for the MI-CARE randomized controlled trial

Lynn L DeBar  1 , Michael A Bushey  2 , Kurt Kroenke  3 , Jennifer F Bobb  4 , Michael Schoenbaum  5 , Ella E Thompson  4 , Morgan Justice  4 , Douglas Zatzick  6 , Leah K Hamilton  4 , Carmit K McMullen  7 , Kevin A Hallgren  8 , Lindsay L Benes  9 , David P Forman  10 , Ryan M Caldeiro  11 , Ryan P Brown  12 , Noll L Campbell  13 , Melissa L Anderson  4 , Sungtaek Son  8 , David A Haggstrom  14 , Lauren Whiteside  6 , Titus K L Schleyer  2 , Katharine A Bradley  15
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A patient-centered nurse-supported primary care-based collaborative care program to treat opioid use disorder and depression: Design and protocol for the MI-CARE randomized controlled trial

Lynn L DeBar et al. Contemp Clin Trials. 2023 Apr.

Abstract

Background: Opioid use disorder (OUD) contributes to rising morbidity and mortality. Life-saving OUD treatments can be provided in primary care but most patients with OUD don't receive treatment. Comorbid depression and other conditions complicate OUD management, especially in primary care. The MI-CARE trial is a pragmatic randomized encouragement (Zelen) trial testing whether offering collaborative care (CC) to patients with OUD and clinically-significant depressive symptoms increases OUD medication treatment with buprenorphine and improves depression outcomes compared to usual care.

Methods: Adult primary care patients with OUD and depressive symptoms (n ≥ 800) from two statewide health systems: Kaiser Permanente Washington and Indiana University Health are identified with computer algorithms from electronic Health record (EHR) data and automatically enrolled. A random sub-sample (50%) of eligible patients is offered the MI-CARE intervention: a 12-month nurse-driven CC intervention that includes motivational interviewing and behavioral activation. The remaining 50% of the study cohort comprise the usual care comparison group and is never contacted. The primary outcome is days of buprenorphine treatment provided during the intervention period. The powered secondary outcome is change in Patient Health Questionnaire (PHQ)-9 depression scores. Both outcomes are obtained from secondary electronic healthcare sources and compared in "intent-to-treat" analyses.

Conclusion: MI-CARE addresses the need for rigorous encouragement trials to evaluate benefits of offering CC to generalizable samples of patients with OUD and mental health conditions identified from EHRs, as they would be in practice, and comparing outcomes to usual primary care. We describe the design and implementation of the trial, currently underway.

Trial registration: ClinicalTrials.gov Identifier: NCT05122676. Clinical trial registration date: November 17, 2021.

Keywords: Behavioral activation; Collaborative care; Depression; Motivational interviewing; Opioid use disorder; Primary care.

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Conflict of interest statement

Declaration of interests

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Competing interests: The authors have no competing interests to disclose.

Figures

Figure 1.
Figure 1.
Overall MI-CARE Study Design and Trial Participant Flow
See this image and copyright information in PMC

References

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