PRimary Care Opioid Use Disorders Treatment (PROUD) Trial

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 1, 2021

Interventions

  • Other: PROUD Intervention
    • 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).

Arms, Groups and Cohorts

  • Active Comparator: PROUD Intervention
    • Primary care clinics randomized to the PROUD Intervention will implement the Massachusetts (MA) Model of collaborative care for opioids use disorders (OUDs). The PROUD trial provides financial support to cover the nurse case manager (NCM) salary and technical assistance for the duration of the study, but the health systems—not investigators—implement the MA Model as part of quality improvement, and the health system and its clinicians provide all clinical care.
  • No Intervention: Usual Primary Care
    • Clinics randomized to usual primary care do not receive any resources or support from the study but are free to improve opioid use disorder (OUD) care in any way they choose.

Clinical Trial Outcome Measures

Primary Measures

  • Patient-days of OUD medication treatment
    • Time Frame: 2-year period post-randomization
    • Clinic-level number of patient-days of OUD treatment with buprenorphine and injectable naltrexone documented in the EHR during the period from randomization until two years after, reported per 10,000 primary care patients in the clinic in the 2 years post-randomization.

Secondary Measures

  • Acute care utilization
    • Time Frame: 2-year period post-randomization
    • Patient-level number of days of acute care utilization during the period from randomization until two years after, among patients with an OUD diagnosis documented in the EHR in the three years prior to randomization.

Participating in This Clinical Trial

Inclusion Criteria

  • 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:

1. Age is 16 to 90 years at any time during the study; and

2. 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)

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kaiser Permanente
  • Collaborator
    • National Institute on Drug Abuse (NIDA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Katharine A Bradley, MD, MPH, Principal Investigator, Kaiser Permanente Washington
  • Overall Contact(s)
    • Megan Addis, 206-287-2052, CTN.PROUD.STUDY@kp.org

References

Alford DP, LaBelle CT, Kretsch N, Bergeron A, Winter M, Botticelli M, Samet JH. Collaborative care of opioid-addicted patients in primary care using buprenorphine: five-year experience. Arch Intern Med. 2011 Mar 14;171(5):425-31. doi: 10.1001/archinternmed.2010.541.

LaBelle CT, Han SC, Bergeron A, Samet JH. Office-Based Opioid Treatment with Buprenorphine (OBOT-B): Statewide Implementation of the Massachusetts Collaborative Care Model in Community Health Centers. J Subst Abuse Treat. 2016 Jan;60:6-13. doi: 10.1016/j.jsat.2015.06.010. Epub 2015 Jun 26.

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