PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment

Abstract

Background Most 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. Methods PROUD 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. Discussion The 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

Receipt of medications for opioid use disorder among youth engaged in primary care: data from 6 health systems

“…This was a cross-sectional, three-year, study using secondary data from Phase 1 of the PRimary care Opioid Use Disorders (PROUD) trial. The PROUD trial was a pragmatic, cluster-randomized implementation trial testing whether a collaborative care model for office-based addiction treatment increased use of medication for OUD in PC (2014–2016) [ 15 ]. PROUD Phase 1 was a preliminary study to identify potential health systems to participate in the trial and assess the feasibility of cohort identification and data collection [ 16 , 17 ].…”

The impact of methamphetamine/amphetamine use on receipt and outcomes of medications for opioid use disorder: a systematic review

“…MOUD are considerably underused, and increasing access to and retention in MOUD treatment, particularly opioid agonist medications, is essential to addressing the opioid crisis and preventing overdose death [ 9 ]. In light of this goal, MOUD are increasingly being provided outside of specialty substance use treatment settings including in primary care [ 13 , 14 ] and community settings such as syringe services programs (SSPs) [ 15 ].…”

Accessibility to Medication for Opioid Use Disorder After Interventions to Improve Prescribing Among Nonaddiction Clinics in the US Veterans Health Care System

“…However, patients in intervention clinics were less likely to be retained for more than 90 or 180 days than patients in comparison clinics. Several studies 23 , 25 , 43 have reported improvements in prescribing outcomes after initiating strategies to increase access to MOUD using hub-and-spoke and nurse care manager models, and several rigorously designed studies are underway, 49 but to our knowledge no prior evaluation has adjusted for secular trends or compared implementation sites to similar sites without intervention exposure.…”