PRimary Care Opioid Use Disorders Treatment (PROUD) Trial
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): PROUD Intervention
Intervention type(s): Other
Intervention description(s): The PROUD intervention includes 3 strategies used to implement the MA Model: 1. Clinic leadership receives funding for a 1.0 full time equivalent NCM for 2 years after randomization and technical support for recruiting and hiring the NCM. Once hired for the study, the NCM will receive technical assistance (TA) from experts at Boston Medical Center (BMC) supported by PROUD, but NCMs will be employed and supervised by the health system. 2. Experts at BMC who originally developed and disseminated the MA Model will: provide intervention clinics with a Manual; train PROUD NCMs at BMC; and provide the ongoing TA for 2 years after randomization. 3. At least 3 primary care providers in the PROUD intervention clinic will obtain DEA waivers to prescribe buprenorphine for OUDs, if not already waivered, and work closely with the NCM to offer high quality primary care for OUDs (e.g. medication treatment with buprenorphine or naltrexone with close follow-up to maximize retention in treatment).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pragmatic Trial: Six health systems are participating in a pragmatic, cluster-randomized, quality improvement trial (hybrid Type III implementation trial). Each of the 6 health systems provided 2 PC clinics willing to be in the randomized controlled trial. Each health system will implement collaborative care for OUD treatment in one randomly selected PC clinic. All data used to evaluate primary and secondary outcomes are secondary data from the EHR or insurance claims.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Opioid Use Disorder; Primary Care; Buprenorphine; Naltrexone