PRimary Care Opioid Use Disorders Treatment (PROUD) Trial

NCT03407638 | Completed DMC

• 2 other identifiers: CTN-0074UG1DA040314
• Study Type: interventional
• Target: 973,759
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Opioid-use Disorder

Keywords

Opioid Use Disorder; Primary Care; Buprenorphine; Naltrexone

Outcome Measures

Primary Outcomes (1)

• Patient-days of OUD medication treatment

  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 (reported as patient-years of treatment per 10,000).

  2-year period post-randomization

Secondary Outcomes (1)

• Acute care utilization

  2-year period post-randomization

Other Outcomes (6)

• Newly recognized OUDs

  2 years after randomization

• Initiation of OUD treatment

  2 years after randomization

• Retention in OUD treatment

  2 years after randomization

Study Arms (2)

PROUD Intervention

ACTIVE COMPARATOR

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.

Other: PROUD Intervention

Usual Primary Care

NO INTERVENTION

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.

Interventions

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).

PROUD Intervention

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The 12 clinics were eligible if their health system leaders agreed they would participate prior to study start.
• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute on Drug Abuse (NIDA): collaborator
• The Emmes Company, LLC: collaborator

Study Sites (6)

University of Miami Health System

Miami, Florida, 33136, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Harris Health System

Houston, Texas, 77054, United States

Location

Kaiser Permanente Washington

Seattle, Washington, 98112, United States

Location

MultiCare Health System

Tacoma, Washington, 98405, United States

Location

Related Publications (7)

• 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.

  PMID: 21403039 BACKGROUND

• 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.

  PMID: 26233698 BACKGROUND

• Lapham GT, Hyun N, Bobb JF, Wartko PD, Matthews AG, Yu O, McCormack J, Lee AK, Liu DS, Samet JH, Zare-Mehrjerdi M, Braciszewski JM, Murphy MT, Arnsten JH, Horigian V, Caldeiro RM, Addis M, Bradley KA. Nurse Care Management of Opioid Use Disorder Treatment After 3 Years: A Secondary Analysis of the PROUD Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2447447. doi: 10.1001/jamanetworkopen.2024.47447.

  PMID: 39576637 DERIVED

• Bobb JF, Idu AE, Qiu H, Yu O, Boudreau DM, Wartko PD, Matthews AG, McCormack J, Lee AK, Campbell CI, Saxon AJ, Liu DS, Altschuler A, Samet JH, Northrup TF, Braciszewski JM, Murphy MT, Arnsten JH, Cunningham CO, Horigian VE, Szapocznik J, Glass JE, Caldeiro RM, Tsui JI, Burganowski RP, Weinstein ZM, Murphy SM, Hyun N, Bradley KA. Offering nurse care management for opioid use disorder in primary care: Impact on emergency and hospital utilization in a cluster-randomized implementation trial. Drug Alcohol Depend. 2024 Aug 1;261:111350. doi: 10.1016/j.drugalcdep.2024.111350. Epub 2024 Jun 10.

  PMID: 38875880 DERIVED

• Wartko PD, Bobb JF, Boudreau DM, Matthews AG, McCormack J, Lee AK, Qiu H, Yu O, Hyun N, Idu AE, Campbell CI, Saxon AJ, Liu DS, Altschuler A, Samet JH, Labelle CT, Zare-Mehrjerdi M, Stotts AL, Braciszewski JM, Murphy MT, Dryden D, Arnsten JH, Cunningham CO, Horigian VE, Szapocznik J, Glass JE, Caldeiro RM, Phillips RC, Shea M, Bart G, Schwartz RP, McNeely J, Liebschutz JM, Tsui JI, Merrill JO, Lapham GT, Addis M, Bradley KA; PROUD Trial Collaborators; Ghiroli MM, Hamilton LK, Hu Y, LaHue JS, Loree AM, Murphy SM, Northrup TF, Shmueli-Blumberg D, Silva AJ, Weinstein ZM, Wong MT, Burganowski RP. Nurse Care Management for Opioid Use Disorder Treatment: The PROUD Cluster Randomized Clinical Trial. JAMA Intern Med. 2023 Dec 1;183(12):1343-1354. doi: 10.1001/jamainternmed.2023.5701.

  PMID: 37902748 DERIVED

• Campbell CI, Saxon AJ, Boudreau DM, Wartko PD, Bobb JF, Lee AK, Matthews AG, McCormack J, Liu DS, Addis M, Altschuler A, Samet JH, LaBelle CT, Arnsten J, Caldeiro RM, Borst DT, Stotts AL, Braciszewski JM, Szapocznik J, Bart G, Schwartz RP, McNeely J, Liebschutz JM, Tsui JI, Merrill JO, Glass JE, Lapham GT, Murphy SM, Weinstein ZM, Yarborough BJH, Bradley KA. PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment. Addict Sci Clin Pract. 2021 Jan 31;16(1):9. doi: 10.1186/s13722-021-00218-w.

  PMID: 33517894 DERIVED

• Bobb JF, Qiu H, Matthews AG, McCormack J, Bradley KA. Addressing identification bias in the design and analysis of cluster-randomized pragmatic trials: a case study. Trials. 2020 Mar 23;21(1):289. doi: 10.1186/s13063-020-4148-z.

  PMID: 32293514 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Katharine A Bradley, MD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistical analysts (biostatisticians) who analyze trial results will be masked for objectives 1 and 2. Main analyses of the primary outcome will be conducted by the National Drug Abuse Treatment Clinical Trials Network (NDAT CTN) Data and Statistics Center (DSC). The de-identified dataset provided to the DSC by the data management team at Kaiser Permanente Washington Health Research Institute will have the identity of the intervention and Usual Primary Care clinic at each site masked.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: January 23, 2018
• Study Start: February 28, 2018
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Investigators will review requests at any time now that the primary paper is published.
• Access Criteria: Sharing of de-identified datasets will be determined on a case-by-case basis by the Lead Investigator.

Locations

US (6)