Trial Outcomes & Findings for PRimary Care Opioid Use Disorders Treatment (PROUD) Trial (NCT NCT03407638)

Last Updated: 2026-06-11

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

377373 participants

Primary outcome timeframe

2-year period post-randomization

Results posted on

2026-06-11

Participant Flow

Unit of analysis: Clinic

Participant milestones

Participant milestones
Measure	PROUD Intervention 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. 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).	Usual Primary Care 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.
Overall Study STARTED	171526 6	205847 6
Overall Study COMPLETED	171526 6	205847 6
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PRimary Care Opioid Use Disorders Treatment (PROUD) Trial

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 2-year period post-randomization

Population: Primary care patients 16 to 90 years old who visited a participating clinic from up to 3 years before a system's randomization date through up to 2 years after.

Outcome measures

Outcome measures
Measure	PROUD Intervention n=6 Clinic 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. 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).	Usual Primary Care n=6 Clinic 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.
Patient-days of OUD Medication Treatment	16.0 Patient-years per 10,000 PC patients Standard Deviation 11.0	14.4 Patient-years per 10,000 PC patients Standard Deviation 11.9

SECONDARY outcome

Timeframe: 2-year period post-randomization

Population: Patients with an OUD diagnosis documented in the EHR in the three years prior to 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.