Differences in benefits of office based opioid treatment: Secondary analyses across sub-groups in the PROUD randomized controlled implementation trial
11/2025
Journal Article
Authors:
Bradley, K. A.;
Hyun, N.;
Idu, A.;
Yu, O.;
Bobb, J. F.;
Wartko, P. D.;
Weinstein, Z.;
Matthews, A. G.;
McCormack, J.;
Lee, A. K.;
Samet, J. H.;
Proud Trial collaborators on sex, race ethnicity.
Journal:
Addiction
PMID:
41287180
URL:
https://www.ncbi.nlm.nih.gov/pubmed/41287180
Keywords:
buprenorphine collaborative care naltrexone nurse care manager opioid use disorder primary care race sex
Abstract:
BACKGROUND AND AIMS: Female, Hispanic, and Black patients with opioid use disorder (OUD) are less likely to receive OUD medication treatment than other patients. The PROUD (PRimary care Opioid Use Disorders treatment) trial demonstrated that implementation of primary care (PC) nurse care management increases OUD medication treatment compared with usual care (UC). This study assessed whether the PROUD intervention's effect differed across sex, race and ethnicity. DESIGN: Secondary analyses of cluster-randomized implementation trial. SETTING: 12 PC clinics (2 per health system) in five states in the USA, randomized to UC or intervention, stratified by health system. PARTICIPANTS: PC patients 16-90 years old. INTERVENTION: Three strategies to implement office-based addiction treatment (OBAT) by nurse care managers: (1) full-time nurse salary; (2) nurse training and technical assistance from expert nurses at Boston Medical Center; (3) >/=3 PC providers willing to prescribe buprenorphine. Nurses were trained in the Massachusetts model of OBAT which includes lowering barriers to OUD treatment, assessing and educating patients, supporting initiation of medications for OUD and providing ongoing medical management, in collaboration with PC providers. MEASUREMENTS: The primary outcome was a clinic-level measure of OUD treatment defined as patient-years of OUD treatment per 10 000 PC patients based on orders and procedures for buprenorphine or extended-release naltrexone from electronic health records and insurance claims (hereafter 'OUD treatment'). FINDINGS: The mean numbers of patients seen by intervention and UC clinics at baseline were 18 485 and 22 557, respectively. Female patients comprised 60% of the total PC population in intervention clinics and 64% in UC clinics; Asian, Black, Hispanic or smaller racial groups comprised 61% of the PC population in intervention clinics, and 70% in UC clinics. Compared with UC, the intervention increased OUD treatment for male patients [adjusted difference: 13.7 patient-years; 95% confidence interval (CI) = 5.8-21.7], but not female patients (2.9; 95% CI = -4.3 to 10.2); effect modification test, F (1,14) = 4.77; P = 0.046. Exploratory analyses suggest that differences in the intervention's effect on receipt of any OUD treatment in female and male patients, rather than differences in the duration of OUD treatment, may account for findings. There was no significant effect modification by race or ethnic group [effect modification test F (4,44) = 1.50; P = 0.218]. CONCLUSIONS: Primary care clinics that implement office-based addiction treatment by nurses increase patient-years of opioid use disorder (OUD) treatment in male but not female patients. Exploratory findings suggest that differences in the proportion of patients treated for OUD, rather than differences in the duration of OUD treatment, account for observed differences across groups.