PRimary Care Opioid Use Disorders Treatment (PROUD) Trial

Effective treatment for opioid use disorders (OUDs) requires medications. Two medications for
treating OUDs—buprenorphine and injectable naltrexone—can be prescribed in primary care (PC).
However, despite the current opioid epidemic and expert recommendations that OUDs should be
treated in PC, most PC clinics do not offer treatment for OUDs. This reflects a lack of
consensus among health system leaders and clinicians that OUDs should be treated in PC.

The PRimary care Opioid Use Disorders treatment (PROUD) Trial is a pragmatic
cluster-randomized, quality improvement trial that evaluates implementation of a team-based
approach to PC supported by a full time nurse (the "PROUD intervention"). This type of
team-based PC is often referred to as "collaborative care" for management of OUDs in PC, and
this type of trial is often referred to as a Hybrid Type III implementation trial.

The trial is being conducted in 6 diverse health systems spanning 5 states (New York,
Florida, Michigan, Texas, and Washington), with 2 PC clinics in each system randomized. One
clinic is randomly selected to implement the PROUD intervention and the other continues usual
PC (UPC).

The overall objective of the PROUD trial is to provide information to guide health system
leaders who are faced with the decision of whether or not to treat OUDs in PC, by evaluating
the benefits of implementing the PROUD intervention that integrates high quality OUD
treatment (i.e. buprenorphine or injectable naltrexone) into the normal flow of PC.

The primary objective of the PROUD trial is to evaluate whether the PROUD intervention
increases OUD treatment with buprenorphine or injectable naltrexone, documented in the
electronic health records (EHRs) of PC patients, over a 2 year follow-up, as compared to UPC.

The primary hypothesis is that there will be a significant increase in the number of
patient-days of medication treatment for OUDs documented in the EHR of PC patients in the 2
years after clinics are randomized to the PROUD intervention compared to PC clinics
randomized to UPC. This implementation objective reflects whether the PROUD intervention
increases initiation of and/or retention in OUD treatment, documented in EHRs within medical
settings.

The main secondary objective is to test the hypothesis that PC patients with OUDs documented
in their EHRs in the 3 years prior to randomization who receive care in PROUD intervention
clinics, compared to those who receive care in UPC clinics, will have fewer days of acute
care utilization (including urgent care, emergency department [ED] and hospital care) in the
2 years after randomization. This effectiveness objective assesses whether implementation of
the MA Model improves patient outcomes.