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Objectives: To identify and value resources required to implement and sustain the Massachusetts model of office-based addiction treatment (MA Model) in the Primary Care Opioid Use Disorders Treatment trial (NCT03407638) using a nurse care manager (NCM) to support medication for opioid use disorder in primary care settings.

Study design: A site-specific microcosting analysis was conducted via activity-based costing. Guided by a structured costing instrument, we conducted semistructured interviews with relevant personnel and assigned nationally representative costs.

Methods: Data came from 6 health care systems. Costs were categorized as fixed start-up, time dependent, or variable and estimated as annual per-clinic and per-patient costs for implementation and sustainment phases.

Results: Mean implementation cost (ie, year 1 fixed start-up, time-dependent, and variable) was $238,888 per clinic ($3185 per patient); each subsequent year cost $229,676 ($3062 per patient), assuming 75 patients per month and 29% new patient case mix. Mean onetime fixed start-up costs were $9212 per clinic and included supplies and training. Time-dependent costs were $70,446 per clinic and included rent and meetings. Variable costs were $159,229 per clinic and included NCMs’ and prescribers’ clinical duties. On average, NCMs spent 1967.6 hours on MA Model-related work per year (26.2 hours per patient). In sensitivity analyses, costs varied drastically with patient caseload, provider mix, and new patient case mix.

Conclusions: Fixed start-up and time-dependent costs were minimal. Variable costs were 66.7% of implementation costs and 69.3% of costs annually afterward. The primary cost driver was NCM time conducting MA Model-related work. The additional value of the model will depend on associated downstream outcomes. These results may be helpful to health care systems considering implementing the MA Model.

Related protocols: CTN-0074

Introduction:
Primary care patients with opioid use disorder (OUD) may receive treatment in primary care clinics or co-located specialty addiction treatment models. To help guide operational leaders in organizing OUD care delivery systems, we described rates of OUD medication treatment among primary care patients in PRimary care Opioid Use Disorders treatment (PROUD, CTN-0074) trial intervention clinics and four primary care clinics not in the trial because they already had OUD treatment programs in place (exemplar clinics).

Methods:
Primary care patients seen at six PROUD trial intervention clinics that implemented the Massachusetts model of office-based addiction treatment (PROUD clinics) and four exemplar clinics (two co-located specialty models; two primary care models with universal prescribing, in which all primary care providers were expected to treat OUD) were compared. Primary outcomes were person-years (PY) of medication treatment for OUD with buprenorphine or extended-release naltrexone during follow up (3/2018–2/2020) and changes from baseline (3/2016–2/2018).

Results:
Baseline primary care samples included 109,196 patients in PROUD clinics and 101,631 patients in exemplar clinics. Baseline OUD treatment rates varied across exemplar clinics (range: 10.9 to 328.7 PY per 10,000 primary care patients) but were higher than in PROUD clinics at baseline (3.9 PY per 10,000), with exemplar clinics with primary care models (established 2005 and 2017) providing the highest treatment rates to their primary care patients. During follow-up, PROUD clinics nearly tripled treatment, to 14.4 PY per 10,000, whereas most exemplar clinics increased treatment by less than 10% but still had higher treatment rates (range: 12.0 to 359.4 PY per 10,000).

Conclusions:
Primary care OUD treatment rates varied markedly. Exemplar clinics in which all primary care providers were expected to treat OUD had the highest treatment rates at baseline and follow-up, suggesting that universal prescribing is a promising approach to increasing OUD treatment in primary care.

Related protocols: CTN-0074

Background: The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) has supported clinical trials of substance use disorder (SUD) interventions for 25 years. This review describes the use of implementation outcomes across CTN trials, characterizes outcomes included, and identifies gaps and potential opportunities to strengthen implementation research within the CTN and the field of SUD treatment.

Methods: This systematic review included active or completed studies listed on the CTN Dissemination Library webpage as of August 18, 2021, and approved by the CTN for development by January 1, 2022. Study summaries and protocols were reviewed if they: 1) measured at least one implementation outcome and 2) examined a practice change, intervention, or process. Extracted data elements included trial design characteristics, implementation frameworks, and outcome assessment domains informed by the RE-AIM and Proctor Implementation Outcomes Frameworks.

Results: 114 protocols were considered, 42 full-text protocols were screened, and 25 were included for data extraction. Start dates of trials spanned a 20-year period (2004–2024) with latter studies including more implementation outcomes. Fidelity (n = 29) and reach/penetration (n = 26) were the most included implementation outcomes. Equity was not identified in any protocols. Methods of defining, capturing, and evaluating outcomes data varied across trials and outcomes.

Conclusions: The inclusion of implementation outcomes increased over time, perhaps reflecting a growing emphasis on implementation research. Incorporating measures of equity could advance knowledge about differential receipt or effectiveness of SUD interventions. Future research should seek to improve the consistency and comprehensiveness in descriptions of implementation science elements.

Related protocols: CTN-0016, CTN-0056, CTN-0062-Ot, CTN-0064, CTN-0065, CTN-0069, CTN-0074, CTN-0074-A-1, CTN-0075, CTN-0076-Ot, CTN-0079, CTN-0079-A-1, CTN-0088, CTN-0090, CTN-0091, CTN-0095, CTN-0096, CTN-0097, CTN-0098, CTN-0099, CTN-0102, CTN-0103, CTN-0107, CTN-0116, CTN-0121

Introduction: Understanding conditions in which interventions succeed or fail is critical. The PRimary care Opioid Use Disorders treatment (PROUD) trial, a cluster-randomized hybrid study, tested whether implementation of office-based addiction treatment supported by a nurse increased medication of OUD. Six health systems each provided two primary care (PC) clinics that were randomly assigned to implement the intervention or usual care. This secondary, exploratory study used an innovative mixed methods approach to understand contextual factors that consistently distinguished intervention clinics that increased OUD treatment from those that did not.

Methods: The study collected contextual information through field notes, health system debriefs, and nurse interviews. Rapid qualitative analysis using a template based on the Practical, Robust Implementation and Sustainability Model identified themes reflecting the external environment, recipients, and implementation infrastructure. The study used qualitative themes to create binary factors reflecting barriers and facilitators potentially critical to implementation success and assigned clinics a factor value of 1 if present and 0 if absent. Two clinic-level outcomes were defined: 1) significant increase in patient-years of OUD treatment from baseline to two-year follow-up; and 2) high rate of OUD treatment at two-year follow-up (=20 per 10,000 patient-years). Coincidence analysis, a cross-case configurational method, identified difference-makers for both OUD outcomes across intervention clinics.

Results: Qualitative analysis yielded 11 themes which were dichotomized and consolidated into 9 factors. Two factor values perfectly distinguished between intervention clinics with and without increased OUD treatment (outcome #1): (a) presence of strong support from PC staff and providers and (b) lack of OUD treatment in the community. Intervention clinics increased OUD treatment when either factor value was present; when both were absent, clinics did not increase treatment. Strong support from PC staff and providers was independently sufficient to achieve high rates of OUD treatment (outcome #2) while the absence of support explained low rates of treatment. Importantly, strong support from leadership was not sufficient for either outcome.

Conclusions: Strong support from staff and providers consistently differentiated between clinics with increased OUD treatment across both outcomes in the PROUD trial from those without. OUD programs should consider increasing support across clinic roles.

Related protocols: CTN-0074

Generalized linear mixed models (GLMM) are commonly used to analyze clustered data, but when the number of clusters is small to moderate, standard statistical tests may produce elevated type I error rates.

Small-sample corrections have been proposed for continuous or binary outcomes without covariate adjustment. However, appropriate tests to use for count outcomes or under covariate-adjusted models remains unknown.

An important setting in which this issue arises is in cluster-randomized trials (CRTs). Because many CRTs have just a few clusters (e.g., clinics or health systems), covariate adjustment is particularly critical to address potential chance imbalance and/or low power (e.g., adjustment following stratified randomization or for the baseline value of the outcome).

In this study, researchers conducted simulations to evaluate GLMM-based tests of the treatment effect that account for the small (10) or moderate (20) number of clusters under a parallel-group CRT setting across scenarios of covariate adjustment (including adjustment for one or more person-level or cluster-level covariates) for both binary and count outcomes. They illustrated their methods with an application to the CTN PRimary Care Opioid Use Disorders Treatment (PROUD) trial, CTN-0074, a parallel two-group cluster-randomized implementation trial randomizing 12 clinics across 6 health care systems.

The authors find that when the intraclass correlation is non-negligible (= 0.01) and the number of covariates is small (= 2), likelihood ratio tests with a between-within denominator degree of freedom have type I error rates close to the nominal level. When the number of covariates is moderate (= 5), across our simulation scenarios, the relative performance of the tests varied considerably and no method performed uniformly well. Therefore, they recommend adjusting for no more than a few covariates and using likelihood ratio tests with a between-within denominator degree of freedom.

Related protocols: CTN-0074

Importance: The Primary Care Opioid Use Disorders (PROUD) treatment trial was a 2-year implementation trial that demonstrated the Massachusetts office-based addiction treatment (OBAT) model of nurse care management for opioid use disorder (OUD) increased OUD treatment in the 2 years after implementation began (8.2 more patient-years of OUD treatment per 10 000 primary care patients). The intervention was continued for a third year, permitting evaluation of 3-year outcomes.

Objective: To compare OUD medication treatment in intervention and usual care clinics over 3 years of implementation.

Design, setting, and participants: This is a preplanned secondary analysis of a cluster randomized implementation trial, conducted in 6 health systems in 5 states (2 primary care clinics per health system) with clinic randomization stratified by system (assignment notification February 28, 2018 [August 31, 2018, in 1 system]). Data were obtained from electronic health records and insurance claims. Eligible patients were those aged 16 to 90 years visiting intervention or usual care clinics from 3 years before to 2 years after randomization. Patients new to clinics during the third year after randomization could not be included because COVID-19-era transitions to virtual care precluded assignment of patients to clinics. Data analysis occurred from November 2023 to September 2024.

Intervention: Clinics were randomized to intervention or care as usual. Intervention included 3 implementation components: salary for 1 full-time OBAT nurse per intervention clinic; training and ongoing technical assistance for nurses; and 3 or more primary care buprenorphine prescribers.

Main outcome and measures: Patient-years of OUD treatment (buprenorphine or extended-release naltrexone) per 10,000 primary care patients in the 3 years postrandomization. Mixed-effect models adjusted for baseline values of the outcome and included a health system-specific random intercept to account for correlation of clinic pairs within a system.

Results: Prerandomization, a total of 290,071 primary care patients were seen, including 130,618 in intervention clinics (mean [SD] age, 48.6 [17.7] years; mean [SD] female, 59.3% [4.0%]) and 159 453 in usual care clinics (mean [SD] age, 47.2 [17.5] years; mean [SD] female, 64.0% [5.3%]). Over 3 years postrandomization, intervention clinics provided 19.7 (95% CI, 11.1-28.4) more patient-years of OUD treatment per 10 000 primary care patients compared with usual care clinics.

Conclusions: In this secondary analysis of the PROUD cluster randomized trial, after an added year of the intervention, OUD treatment continued to increase in intervention clinics compared with usual care. The treatment increase over 3 years exceeded that of the first 2 years, suggesting that implementation of the Massachusetts OBAT model leads to ongoing increases in OUD treatment among primary care patients in the third year of implementation.

Related protocols: CTN-0074

Patients with opioid use disorder (OUD) have increased emergency and hospital utilization. The PROUD trial showed that implementation of office-based addiction treatment (OBAT) increased OUD medication treatment compared to usual care, but did not decrease acute care utilization in patients with OUD documented pre-randomization (clinicaltrials.gov/study/NCT03407638). This paper reports secondary emergency and hospital utilization outcomes in patients with documented OUD in the PROUD trial.

This cluster-randomized implementation trial was conducted in 12 clinics from 6 diverse health systems (March 2015-February 2020). Patients who visited trial clinics and had an OUD diagnosis within 3 years pre-randomization were included in primary analyses; secondary analyses added patients with OUD who were new to the clinic or with newly-documented OUD post-randomization. Outcomes included days of emergency care and hospital utilization over 2 years post-randomization. Explanatory outcomes included measures of OUD treatment. Patient-level analyses used mixed-effect regression with clinic-specific random intercepts.

Among 1988 patients with documented OUD seen pre-randomization (mean age 49, 53% female), days of emergency care or hospitalization did not differ between intervention and usual care; OUD treatment also did not differ. In secondary analyses among 1347 patients with OUD post-randomization, there remained no difference in emergency or hospital utilization despite intervention patients receiving 32.2 (95% CI 4.7, 59.7) more days of OUD treatment relative to usual care.

Conclusions: Implementation of OBAT did not reduce emergency or hospital utilization among patients with OUD, even in the sample with OUD first documented post-randomization in whom the intervention increased treatment.

Related protocols: CTN-0074

Few primary care (PC) practices treat patients with medications for opioid use disorder (OUD) despite availability of effective treatments. The purpose of this study was to assess whether implementation of the Massachusetts model of nurse care management for OUD in PC increases OUD treatment with buprenorphine or extended-release injectable naltrexone and secondarily decreases acute care utilization.

The National Drug Abuse Treatment Clinical Trials Network (CTN) Primary Care Opioid Use Disorders Treatment (PROUD) trial was a mixed-methods, implementation-effectiveness cluster randomized clinical trial conducted in 6 diverse health systems across 5 US states (New York, Florida, Michigan, Texas, and Washington). Two PC clinics in each system were randomized to intervention or usual care (UC) stratified by system (5 systems were notified on February 28, 2018, and 1 system with delayed data use agreement on August 31, 2018). Data were obtained from electronic health records and insurance claims. An implementation monitoring team collected qualitative data. Primary care patients were included if they were 16 to 90 years old and visited a participating clinic from up to 3 years before a system’s randomization date through 2 years after.

The PROUD intervention included 3 components: (1) salary for a full-time OUD nurse care manager; (2) training and technical assistance for nurse care managers; and (3) 3 or more PC clinicians agreeing to prescribe buprenorphine.

The primary outcome was a clinic-level measure of patient-years of OUD treatment (buprenorphine or extended-release injectable naltrexone) per 10 000 PC patients during the 2 years postrandomization (follow-up). The secondary outcome, among patients with OUD prerandomization, was a patient-level measure of the number of days of acute care utilization during follow-up.

During the baseline period, a total of 130 623 patients were seen in intervention clinics (mean [SD] age, 48.6 [17.7] years; 59.7% female), and 159 459 patients were seen in UC clinics (mean [SD] age, 47.2 [17.5] years; 63.0% female). Intervention clinics provided 8.2 (95% CI, 5.4-8) more patient-years of OUD treatment per 10 000 PC patients compared with UC clinics (P = .002). Most of the benefit accrued in 2 health systems and in patients new to clinics (5.8 [95% CI, 1.3-8] more patient-years) or newly treated for OUD postrandomization (8.3 [95% CI, 4.3-8] more patient-years). Qualitative data indicated that keys to successful implementation included broad commitment to treat OUD in PC from system leaders and PC teams, full financial coverage for OUD treatment, and straightforward pathways for patients to access nurse care managers. Acute care utilization did not differ between intervention and UC clinics (relative rate, 1.16; 95% CI, 0.47-2.92; P = .70).

Conclusions: The PROUD cluster randomized clinical trial intervention meaningfully increased PC OUD treatment, albeit unevenly across health systems; however, it did not decrease acute care utilization among patients with OUD.

Related protocols: CTN-0074

Pragmatic primary care trials aim to test interventions in “real world” health care settings, but clinics willing and able to participate in trials may not be representative of typical clinics. This analysis compared patients in participating and non-participating clinics from the same health systems at baseline in the PRimary care Opioid Use Disorders treatment (PROUD) trial (CTN-0074).

This observational analysis relied on secondary electronic health record and administrative claims data in 5 of 6 health systems in the PROUD trial. The sample included patients aged 16–90 years at an eligible primary care visit in the 3 years before randomization. Each system contributed 2 randomized PROUD trial clinics and 4 similarly sized non-trial clinics. We summarized patient characteristics in trial and non-trial clinics in the 2 years before randomization (“baseline”). Using mixed-effect regression models, researchers compared trial and non-trial clinics on a baseline measure of the primary trial outcome (clinic-level patient-years of opioid use disorder (OUD) treatment, scaled per 10,000 primary care patients seen) and a baseline measure of the secondary trial outcome (patient-level days of acute care utilization among patients with OUD).

Patients were generally similar between the 10 trial clinics (n = 248,436) and 20 non-trial clinics (n = 341,130), although trial clinics’ patients were slightly younger, more likely to be Hispanic/Latinx, less likely to be white, more likely to have Medicaid/subsidized insurance, and lived in less wealthy neighborhoods. Baseline outcomes did not differ between trial and non-trial clinics: trial clinics had 1.0 more patient-year of OUD treatment per 10,000 patients (95% CI: – 2.9, 5.0) and a 4% higher rate of days of acute care utilization than non-trial clinics (rate ratio: 1.04; 95% CI: 0.76, 1.42).

Conclusions: Trial clinics and non-trial clinics were similar regarding most patient characteristics, and no differences were observed in baseline measures of trial primary and secondary outcomes. These findings suggest trial clinics were representative of comparably sized clinics within the same health systems. Although results do not reflect generalizability more broadly, this study illustrates an approach to assess representativeness of clinics in future pragmatic primary care trials.

Related protocols: CTN-0074

In this study, the researchers sought to characterize the 3-year prevalence of mental disorders and non-nicotine substance use disorders among male and female primary care patients with documented opioid use disorder across large U.S. health systems.

This retrospective study used 2014–2016 data (from CTN-0074) from patients ages =16 years in six health systems. Diagnoses were obtained from electronic health records or claims data; opioid use disorder treatment with buprenorphine or injectable extended-release naltrexone was determined through prescription and procedure data. Adjusted prevalence of comorbid conditions among patients with opioid use disorder (with or without treatment), stratified by sex, was estimated by fitting logistic regression models for each condition and applying marginal standardization.

Females (53.2%, N=7,431) and males (46.8%, N=6,548) had a similar prevalence of opioid use disorder. Comorbid mental disorders among those with opioid use disorder were more prevalent among females (86.4% vs. 74.3%, respectively), whereas comorbid other substance use disorders (excluding nicotine) were more common among males (51.9% vs. 60.9%, respectively). These differences held for those receiving medication treatment for opioid use disorder, with mental disorders being more common among treated females (83% vs. 71%) and other substance use disorders more common among treated males (68% vs. 63%). Among patients with a single mental health condition comorbid with opioid use disorder, females were less likely than males to receive medication treatment for opioid use disorder (15% vs. 20%, respectively).

Conclusions: The high rate of comorbid conditions among patients with opioid use disorder indicates a strong need to supply primary care providers with adequate resources for integrated opioid use disorder treatment.

Related protocols: CTN-0074

Hepatitis C (HCV) and HIV are associated with opioid use disorders (OUD) and injection drug use. Medications for OUD can prevent the spread of HCV and HIV. This study aimed to describe the prevalence of documented OUD, as well as receipt of office-based medication treatment, among primary care patients with HCV or HIV, using data collected from Phase 1 of the PRimary care Opioid Use Disorders (PROUD) Study (CTN-0074), a pragmatic trial testing whether a collaborative care model increases OUD medication treatment in primary care. Electronic health record and insurance data for adults 18 or older with 2 or more visits to primary care during the study were analyzed. The primary outcome was the diagnosis of OUD; the secondary outcome was OUT treatment with buprenorphine or oral/injectable naltrexone. Prevalence of OUD and OUD treatment was calculated across four groups: HCV only, HIV only, HCV and HIV, and neither HCV nor HIV. In addition, adjusted odds ratios (AOR) of OUD treatment associated with HCV and HIV (separately) were estimated, adjusting for age, gender, race/ethnicity, and site.

The sample included 1,368,604 people, of whom 10,042 had HCV, 5,821 HIV, and 422 both. The prevalence of diagnosed OUD varied across groups: 11.9% for those with HCV, 1.6% for those with HIV, 8.8% for those with both, and 0.92% for those with neither. Among those with diagnosed OUD, the prevalence of OUD medication treatment was 20.9%, 16%, 10.8%, and 22.3% for those with HCV, HIV, both, and neither, respectively. HCV was not associated with OUD treatment, whereas patients with HIV had a lower probability of OUD treatment.

Conclusions: Among patients receiving primary care, those diagnosed with HCV and HIV were more likely to have documented OUD than those without, with the highest prevalence (11.9%) occurring among patients with HCV. Receipt of medication treatment for OUD was uniformly low for all patients, including those with HCV and HIV, with only up to 1/5 of patients with OUD receiving buprenorphine or naltrexone. The finding that patients with HIV who had OUD were less likely to received medication treatment for OUD compared to uninfected patients was unexpected and merits further investigation. These results highlight the need for improved access to medications for OUD, particularly from providers caring for patients living with HCV/HIV. Providing effective treatment for OUD is critical for maximizing the health of people living with HIV and HCV, as well as preventing transmission of these diseases.

Related protocols: CTN-0074

Most people with opioid use disorder (OUD) never receive treatment. Medication treatment of OUD in primary care is recommended as an approach to increase access to care. The PRimary Care Opioid Use Disorders treatment (PROUD) trial tests whether implementation of a collaborative care model (Massachusetts Model) using a nurse care manager (NCM) to support medication treatment of OUD in primary care increases OUD treatment and improves outcomes. Specifically, it tests whether implementation of collaborative care, compared to usual primary care, increases the number of days of medication for OUD (implementation objective) and reduces acute health care utilization (effectiveness objective). The protocol for the PROUD trial is presented here.

PROUD is a hybrid type III cluster-randomized implementation trial in six health care systems. The intervention consists of three implementation strategies: salary for a full-time NCM, training and technical assistance for the NCM, and requiring that three primary care providers have DEA waivers to prescribe buprenorphine. Within each health system, two primary care clinics are randomized: one to the intervention and one to Usual Primary Care. The sample includes all patients age 16–90 who visited the randomized primary care clinics from 3 years before to 2 years after randomization (anticipated to be > 170,000). Quantitative data are derived from existing health system administrative data, electronic medical records, and/or health insurance claims (“electronic health records,” [EHRs]). Anonymous staff surveys, stakeholder debriefs, and observations from site visits, trainings and technical assistance provide qualitative data to assess barriers and facilitators to implementation. The outcome for the implementation objective (primary outcome) is a clinic-level measure of the number of patient days of medication treatment of OUD over the 2 years post-randomization. The patient-level outcome for the effectiveness objective (secondary outcome) is days of acute care utilization [e.g. urgent care, emergency department (ED) and/or hospitalizations] over 2 years post-randomization among patients with documented OUD prior to randomization.

Discussion: The PROUD trial provides information for clinical leaders and policy makers regarding potential benefits for patients and health systems of a collaborative care model for management of OUD in primary care, tested in real-world diverse primary care settings.

Related protocols: CTN-0074

Pragmatic trials provide the opportunity to study the effectiveness of health interventions to improve care in real-world settings. However, use of open-cohort designs with patients becoming eligible after randomization and reliance on electronic health records (EHRs) to identify participants may lead to a form of selection bias referred to as identification bias. This bias can occur when individuals identified as a result of the treatment group assignment are included in analyses.

To demonstrate the importance of identification bias and how it can be addressed, the authors consider a motivating case study, the CTN PRimary care Opioid Use Disorders treatment (PROUD) Trial. PROUD is an ongoing pragmatic, cluster-randomized implementation trial in six health systems to evaluate a program for increasing medication treatment of opioid use disorders (OUDs). A main study objective is to evaluate whether the PROUD intervention decreases acute care utilization among patients with OUD (effectiveness aim). Identification bias is a particular concern, because OUD is underdiagnosed in the EHR at baseline, and because the intervention is expected to increase OUD diagnosis among current patients and attract new patients with OUD to the intervention site. We propose a framework for addressing this source of bias in the statistical design and analysis.

The statistical design sought to balance the competing goals of fully capturing intervention effects and mitigating identification bias, while maximizing power. For the primary analysis of the effectiveness aim, identification bias was avoided by defining the study sample using pre-randomization data (pre-trial modeling demonstrated that the optimal approach was to use individuals with a prior OUD diagnosis). To expand generalizability of study findings, secondary analyses were planned that also included patients newly diagnosed post-randomization, with analytic methods to account for identification bias.

Conclusions: As more studies seek to leverage existing data sources, such as EHRs, to make clinical trials more affordable and generalizable and to apply novel open-cohort study designs, the potential for identification bias is likely to become increasingly common. This case study highlights how this bias can be addressed in the statistical study design and analysis.

Related protocols: CTN-0074

The United States is in the middle of an opioid overdose epidemic, and experts are calling for improved detection of opioid use disorders (OUDs) and treatment with buprenorphine or extended release (XR) injectable naltrexone, which can be prescribed in general medical settings. To better understand the magnitude of opportunities for treatment among primary care (PC) patients, we estimated the prevalence of documented OUD and medication treatment of OUD among PC patients.

This cross-sectional study resulted from a feasibility test as a prelude to a CTN pragmatic implementation trial to improve treatment of OUD in primary care (CTN-0074, PROUD Treatment Trial). It included patients with =2 visits to PC clinics across 6 healthcare delivery systems who were =16 years of age during the study period (fiscal years 2014-2016). Diagnoses, prescriptions, and healthcare utilization were ascertained from electronic health records and insurance claims (5 systems that also offer health insurance). Documented OUDs were defined as =1 International Classification of Diseases code for OUDs (active or remission), and OUD treatment was defined as =1 prescription(s) for buprenorphine formulations indicated for OUD or naltrexone XR, during the 3-year study period. The prevalence of documented OUD and treatment (95% confidence intervals) across health systems were estimated, and characteristics of patients by treatment status were compared. Prevalence of OUD and OUD treatment were adjusted for age, gender, and race/ethnicity. Combined results were also adjusted for site.

Among 1,403,327 eligible PC patients, 54-62% were female and mean age ranged from 46 to 51 years across health systems. The 3-year prevalence of documented OUD ranged from 0.7-1.4% across the health systems. Among patients with documented OUD, the prevalence of medication treatment (primarily buprenorphine) varied across health systems: 3%, 12%, 16%, 20%, 22%, and 36%.

Conclusions: The prevalence of documented OUD and OUD treatment among PC patients varied widely across health systems. The majority of PC patients with OUD did not have evidence of treatment with buprenorphine or naltrexone XR, highlighting opportunities for improved identification and treatment in medical settings. These results can inform initiatives aimed at improving treatment of OUD in PC. Future research should focus on why there is such variation and how much of the variation can be addressed by improving access to medication treatment.

Related protocols: CTN-0074

The U.S. experienced nearly 48,000 opioid overdose deaths in 2017. Treatment of opioid use disorder (OUD) with buprenorphine is a recommended part of primary care, yet little is known about current U.S. practices in this setting. This observational study reports the prevalence of documented OUD and OUD treatment with buprenorphine among primary care patients in six large health systems.

Adults with 2 or more primary care visits during a three-year period (October 1, 2013 to September 30, 2015) in six health systems were included. Data were obtained from electronic health record and claims data, with measures, assessed over the 3-year period, including indicators for documented OUD from ICD 9 and 10 codes and OUD treatment with buprenorphine. The prevalence of OUD treatment was adjusted for age, gender, race/ethnicity, and health system.

Among 1,368,604 primary care patients, 13,942 (1%) had documented OUD, and among those, 21% had OUD treatment with buprenorphine. For those with documented OUD, the adjusted prevalence of OUD treatment with buprenorphine varied across demographic and clinical subgroups. OUD treatment was lower among patients who were older, women, Black/African American and Hispanic (compared to white), non-commercially insured, and those with non-cancer pain, mental health disorders, greater comorbidity, and more opioid prescriptions, emergency department visits or hospitalizations.

Conclusions: This study has important strengths and findings and provides a stark picture of the gap in treatment for patients with OUD. Among primary care patients in six health systems, one in five with OUD were treated with buprenorphine with disparities across demographic and clinical characteristics. Less buprenorphine treatment among those with greater acute care utilization highlights an opportunity for systems-level changes to increase OUD treatment.

Related protocols: CTN-0074