PRimary Care Opioid Use Disorders Treatment (PROUD) Trial

Opioid-use Disorder Clinical Trial

— PROUD  

Official title:

PRimary Care Opioid Use Disorders Treatment (PROUD) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03407638
• Other study ID #: CTN-0074
• Secondary ID: UG1DA040314
• Status: Completed
• Phase: N/A
• Start date: February 28, 2018
• Est. completion date: February 29, 2020

Study information

• Verified date: February 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 973759
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

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).

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Henry Ford Health System	Detroit	Michigan
United States	Harris Health System	Houston	Texas
United States	University of Miami Health System	Miami	Florida
United States	Kaiser Permanente Washington	Seattle	Washington
United States	MultiCare Health System	Tacoma	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Kaiser Permanente	National Institute on Drug Abuse (NIDA), The Emmes Company, LLC

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Newly recognized OUDs	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 three years prior to randomization, reported per 10,000 primary care patients in the clinic in the 2 years post-randomization.	2 years after randomization
Other	Initiation of OUD treatment	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 patients in the clinic in the 2 years post-randomization. Measure will be calculated for any initiation and separately for initiation of each type of medication.	2 years after randomization
Other	Retention in OUD treatment	Clinic-level number of patients initiating 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 patients in the clinic in the 2 years post-randomization.	2 years after randomization
Other	Urgent care or ED use	Patient-level number of visits 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.	2 years after randomization
Other	Inpatient Days hospitalized	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.	2 years after randomization
Other	Naloxone prescribing	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.	2 years after randomization
Primary	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.	2-year period post-randomization
Secondary	Acute care utilization	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.	2-year period post-randomization