Clinical trial NCT03407638: PRimary Care Opioid Use Disorders Treatment (PROUD) Trial
Official title: PRimary Care Opioid Use Disorders Treatment (PROUD) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Keywords: Opioid Use Disorder
Primary Care
Buprenorphine
Naltrexone
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: The Emmes Company, LLC
First posted: 2018-01-23
Enrollment: 973759
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient-days of OUD medication treatment
timeFrame: 2-year period post-randomization
Secondary outcomes:
measure: Acute care utilization
timeFrame: 2-year period post-randomization
Other outcomes:
measure: Newly recognized OUDs
timeFrame: 2 years after randomization
measure: Initiation of OUD treatment
timeFrame: 2 years after randomization
measure: Retention in OUD treatment
timeFrame: 2 years after randomization
measure: Urgent care or ED use
timeFrame: 2 years after randomization
measure: Inpatient Days hospitalized
timeFrame: 2 years after randomization
measure: Naloxone prescribing
timeFrame: 2 years after randomization
Locations:
city: Miami
country: United States
facility: University of Miami Health System
state: Florida
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Houston
country: United States
facility: Harris Health System
state: Texas
city: Seattle
country: United States
facility: Kaiser Permanente Washington
state: Washington
city: Tacoma
country: United States
facility: MultiCare Health System
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Katharine A Bradley, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.
citation: 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.