PRimary Care Opioid Use Disorders Treatment (PROUD) Trial

Completed · Not applicable

Conditions studied: Opioid-use Disorder

In brief

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.

Key facts

Study ID: NCT03407638
Run by: Kaiser Permanente
People needed: 377373
Starts: 2018-02-28
Expected to finish: 2020-02-29
Last updated by the study team: 2026-06-11

Who can join

Age: 16 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

The 12 clinics were eligible if their health system leaders agreed they would participate prior to study start.
Patients are eligible for inclusion in the sample for analyses of the PROUD trial if they visited one of the randomized clinics at any time in the 5 year study period. Specific inclusion criteria for the trial are:
Age is 16 to 90 years at any time during the study; and
Visited a PROUD trial primary care clinic in the 3 years prior to randomization or the 2 years after (note: one of the 6 study sites may only be able to provide EHR data for 2 years before randomization)

You may not qualify if…

Patients who have requested through their health systems to opt out of research will be excluded from this study.

Where it is running

University of Miami Health System — Miami, Florida, United States
Henry Ford Health System — Detroit, Michigan, United States
Montefiore Medical Center — The Bronx, New York, United States
Harris Health System — Houston, Texas, United States
Kaiser Permanente Washington — Seattle, Washington, United States
MultiCare Health System — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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