Abstract

BackgroundMost people with opioid use disorder (OUD) never receive treatment. Medication treatment of OUD in primary care is recommended as an approach to increase access to care. The PRimary Care Opioid Use Disorders treatment (PROUD) trial tests whether implementation of a collaborative care model (Massachusetts Model) using a nurse care manager (NCM) to support medication treatment of OUD in primary care increases OUD treatment and improves outcomes. Specifically, it tests whether implementation of collaborative care, compared to usual primary care, increases the number of days of medication for OUD (implementation objective) and reduces acute health care utilization (effectiveness objective). The protocol for the PROUD trial is presented here.MethodsPROUD is a hybrid type III cluster-randomized implementation trial in six health care systems. The intervention consists of three implementation strategies: salary for a full-time NCM, training and technical assistance for the NCM, and requiring that three primary care providers have DEA waivers to prescribe buprenorphine. Within each health system, two primary care clinics are randomized: one to the intervention and one to Usual Primary Care. The sample includes all patients age 16–90 who visited the randomized primary care clinics from 3 years before to 2 years after randomization (anticipated to be > 170,000). Quantitative data are derived from existing health system administrative data, electronic medical records, and/or health insurance claims (“electronic health records,” [EHRs]). Anonymous staff surveys, stakeholder debriefs, and observations from site visits, trainings and technical assistance provide qualitative data to assess barriers and facilitators to implementation. The outcome for the implementation objective (primary outcome) is a clinic-level measure of the number of patient days of medication treatment of OUD over the 2 years post-randomization. The patient-level outcome for the effectiveness objective (secondary outcome) is days of acute care utilization [e.g. urgent care, emergency department (ED) and/or hospitalizations] over 2 years post-randomization among patients with documented OUD prior to randomization.DiscussionThe PROUD trial provides information for clinical leaders and policy makers regarding potential benefits for patients and health systems of a collaborative care model for management of OUD in primary care, tested in real-world diverse primary care settings.Trial registration # NCT03407638 (February 28, 2018); CTN-0074 https://clinicaltrials.gov/ct2/show/NCT03407638?term=CTN-0074&draw=2&rank=1

Highlights

  • MethodsPRimary Care Opioid Use Disorders treatment (PROUD) is a hybrid type III cluster-randomized implementation trial in six health care systems

  • Of the more than 2 million individuals in the United States with opioid use disorder (OUD), the vast majority do not receive treatment [1, 2]

  • The primary implementation hypothesis is that the number of patient days of medication treatment of OUD is significantly greater in clinics randomized to the PRimary Care Opioid Use Disorders treatment (PROUD) intervention compared to clinics randomized to Usual primary care (PC)

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Summary

Methods

Objectives and hypotheses The PROUD trial is a pragmatic, hybrid type III clusterrandomized implementation trial [22], a design which includes both a primary implementation objective and a secondary effectiveness outcome. Data sources include: observations of NCM trainings in Boston, the TA team’s site visit(s) to intervention clinics, and weekly TA team videoconference calls with the NCMs; bi-monthly to monthly debriefs with the TA team to review facilitators and barriers from all sites; review of email communications using a central study email box for all trial-related communication, site debriefs with Site PIs and project managers including periodic “all-site” phone meetings (initially weekly and decreasing frequency over the trial) and ad hoc or scheduled debriefs with a single site These qualitative data are used as part of formative evaluation to provide feedback at weekly leadership meetings leading to discussions about whether refinements or adaptations of the three implementation strategies are needed. To account for varying clinic sizes, the outcome is divided by the number of patients seen in the clinics during that time period and multiplied by an appropriate scaling factor in order to report the results

Discussion
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