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NCT03407638 · ClinicalTrials.gov registry record · NA

PRimary Care Opioid Use Disorders Treatment (PROUD) Trial

A NA study of Opioid Use Disorder, sponsored by Kaiser Permanente.

Completed
Registry status
NA
Development phase
973,759
Enrollment target
6
Study locations

NCT03407638: Completed NA study of Opioid Use Disorder, sponsored by Kaiser Permanente.

NCT03407638 is a NA study of Opioid Use Disorder that has completed, run by Kaiser Permanente. The registered enrollment target is 973,759 participants, above the 867-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (112214% higher). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03407638, a NA study of Opioid Use Disorder, has completed, sponsored by Kaiser Permanente.

COMPLETED
Registry status
NA
Development phase
973,759 participants
Enrollment target
6
Study locations

Study 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 rand

Primary Outcome

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).

Conditions Studied

Opioid Use Disorder

Interventions

  • OTHER PROUD Intervention

Study Locations (6)

Washington

  • Kaiser Permanente Washington - Seattle
  • MultiCare Health System - Tacoma

Florida

  • University of Miami Health System - Miami

Michigan

  • Henry Ford Health System - Detroit

New York

  • Montefiore Medical Center - The Bronx

Texas

  • Harris Health System - Houston

Trial Details

FieldValue
Enrollment Target 973,759 participants
Start Date 2018-02-28
Est. Completion 2020-02-29
Phase NA
Kaiser Permanente

294 total trials

What the finished NCT03407638 record still lists

NCT03407638 is an interventional study that assigns participants to a tested intervention. Its 973,759 participants enrollment target places it among the larger protocols in the corpus, above the 867-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (112214% higher).

The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which PROUD Intervention is the first listed.

NCT03407638 lists 6 locations in 5 states (Washington, Florida, Michigan).

Frequently Asked Questions

What is clinical trial NCT03407638 about?

NCT03407638 is a clinical study titled "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 ...

What is the current status of trial NCT03407638?

This trial is currently completed. It is a NA study. The enrollment target is 973,759 participants. The study started on 2018-02-28. Estimated completion is 2020-02-29.

What conditions does trial NCT03407638 study?

This clinical trial studies the following conditions: Opioid Use Disorder.

What interventions are being tested in trial NCT03407638?

The interventions under investigation include: PROUD Intervention (OTHER).

Who is sponsoring clinical trial NCT03407638?

This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03407638 being conducted?

This trial has 6 study locations across Florida, Michigan, New York, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Opioid Use Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03407638's enrollment target sits among peer trials

973,759 1st of 257 higher than 257 of 257 other Opioid Use Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03407638, the US trial registry maintained by the National Library of Medicine. NCT03407638 (large enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.