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Completed

NCT Number: NCT03407638

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

16 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Health System, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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)

Exclusion criteria

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

Treatment and study plan

PROUD Intervention

Other

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).

Primary outcomes

  1. 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 (PC) patients in the clinic in the 2 years post-randomization (reported as patient-years of treatment per 10,000).

Secondary outcomes

  1. 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.

Other outcomes

  1. Newly Recognized OUDs

    Time frame: 2 years after randomization

    Clinic-level number of patients with a new International Classification of Disease (ICD) code for OUD documented in the EHR during the period from randomization until two years after who did not have an OUD diagnosis documented in the EHR in the two years prior to randomization, reported per 10,000 primary care (PC) patients in the clinic in the 2 years post-randomization.

  2. Initiation of OUD Treatment

    Time frame: 2 years after randomization

    Clinic-level number of patients who initiate (1) buprenorphine or (2) injectable naltrexone with an OUD diagnosis as documented in the EHR during the period from randomization until two years after, reported per 10,000 primary care (PC) patients in the clinic in the 2 years post-randomization. Measure will be calculated for any initiation.

  3. Retention in OUD Treatment

    Time frame: 2 years after randomization

    Clinic-level number of patients with OUD treatment during the period from randomization until two years after randomization as documented in the EHR, who also receive OUD treatment on 80% of days available after initiation, reported per 10,000 primary care (PC) patients in the clinic in the 2 years post-randomization.

  4. Urgent Care or ED Use

    Time frame: 2 years after randomization

    Patient-level number of days with a visit to urgent care or EDs 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.

  5. Inpatient Days Hospitalized

    Time frame: 2 years after randomization

    Patient-level number of days hospitalized 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.

  6. Naloxone Prescribing

    Time frame: 2 years after randomization

    Patient-level number of prescriptions of naloxone for overdose management in the period from randomization until two years after, among patients with an OUD diagnoses in the three years prior to randomization.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • The Emmes Company, LLC

Registry information

Acronym: PROUD

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 23, 2018
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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