Nurse Care Management for Opioid Use Disorder Treatment: The PROUD Cluster Randomized Clinical Trial.

Importance: Few primary care (PC) practices treat patients with medications for opioid use disorder (OUD) despite availability of effective treatments. Objective: 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. Design, Setting, and Participants: The 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. Intervention: 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. Main Outcomes and Measures: 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. Results: 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-∞) 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-∞] more patient-years) or newly treated for OUD postrandomization (8.3 [95% CI, 4.3-∞] 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 and Relevance: 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. Trial Registration: ClinicalTrials.gov Identifier: NCT03407638.

Starting the Discussion: A Call to Enhance Care for People With Stimulant Use Disorder.

Stimulant use disorder (StUD) significantly contributes to substance-related morbidity and mortality in the United States. Overshadowed by the country's focus on opioid-related overdose deaths, stimulant and stimulant/opioid overdose deaths have increased dramatically over the last decade. Many individuals who use stimulants illicitly or have StUD have multiple, intersecting stigmatized characteristics which exacerbate existing barriers and create new obstacles to attaining addiction treatment. Illicit stimulant use, StUD, and stimulant-related overdose disproportionately impact minoritized racial and gender, and sexuality diverse groups. Historically, people who use illicit stimulants and those with StUD have been highly stigmatized, criminalized, and overly ignored by health care providers, policymakers, and the public compared to people who use other drugs and alcohol. As a result, most people needing treatment for StUD do not receive it. This is partly due to the lack of evidence-based treatment for StUD, which has resulted in few programs specializing in the care of people with StUD. The lack of available treatment is compounded by high rates of StUD in marginalized groups already reluctant to engage with the health care system. As health care professionals, we can improve outcomes for people with StUD by changing how we talk about, document, and respond to illicit stimulant use, related characteristics, behaviors, and social and structural determinants of health. To do this, we must seek to understand the lived realities of people with StUD and illicit stimulant use and use this knowledge to amend existing models of care.

Evaluation of the New England Office Based Addiction Treatment ECHO: A Tool for Strengthening the Addiction Workforce.

INTRODUCTION: Reducing substance-related morbidity requires an educated and well-supported workforce. The New England Office Based Addiction Treatment Extension for Community Healthcare Outcomes (NE OBAT ECHO) began in 2019 to support community-based addiction care teams through virtual mentoring and case-based learning. We sought to characterize the program's impact on the knowledge and attitudes of NE OBAT ECHO participants. METHODS: We conducted an 18-month prospective evaluation of the NE OBAT ECHO. Participants registered for 1 of 2 successive ECHO clinics. Each 5-month clinic included ten 1.5-hour sessions involving brief didactic lectures and de-identified patient case presentations. Participants completed surveys at Month-0, -6, -12, and -18 to assess attitudes about working with patients who use drugs and evidence based practices (EBPs), stigma toward people who use drugs, and addiction treatment knowledge. We compared outcomes using 2 approaches: (i) between-groups, which involved comparing the first intervention group to the delayed intervention (comparison) group, and (ii) within-groups, which involved comparing outcomes at different time points for all participants. In the within-group approach, each participant acted as their own control. RESULTS: Seventy-six health professionals participated in the NE OBAT ECHO, representing various roles in addiction care teams. Approximately half (47% [36/76]) practiced primary care, internal, or family medicine. The first intervention group reported improved job satisfaction and openness toward EBPs compared to the delayed intervention group. Within-group analyses revealed that ECHO participation was associated with increased positive perceptions of role adequacy, support, legitimacy, and satisfaction 6 months following program completion. No changes were identified in willingness to adopt EBPs or treatment knowledge. Stigma toward people who use drugs was persistent in both groups across time points. CONCLUSIONS: NE OBAT ECHO may have improved participants' confidence and satisfaction providing addiction care. ECHO is likely an effective educational tool for expanding the capacity of the addiction workforce.

Addiction Nursing Competencies: A Comprehensive Toolkit for the Addictions Nurse.

With the increased role of nurses in caring for patients with substance addiction, there was a clear need to develop the Addiction Nursing Competencies to guide and support the nursing workforce. A literature search revealed a lack of formal instruments to assess and guide nurses in caring for persons with substance use disorders. The Addiction Nursing Competencies were created using existing nursing education frameworks and addiction nurse care manager clinical guidelines.

PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment.

BACKGROUND: 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. METHODS: 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. Trial registration # NCT03407638 (February 28, 2018); CTN-0074 https://clinicaltrials.gov/ct2/show/NCT03407638?term=CTN-0074&draw=2&rank=1.

Long-term retention in Office Based Opioid Treatment with buprenorphine.

BACKGROUND: Guidelines recommend long-term treatment for opioid use disorder with buprenorphine; however, little is known about patients in long-term treatment. The aim of this study is to examine the prevalence and patient characteristics of long-term treatment retention (≥1year) in an Office Based Opioid Treatment (OBOT) program with buprenorphine. METHODS: This is a retrospective cohort study of adults on buprenorphine from January 2002 to February 2014 in a large urban safety-net primary care OBOT program. The primary outcome was retention in OBOT for at least one continuous year. Potential predictors included age, race, psychiatric diagnoses, hepatitis C, employment, prior buprenorphine, ever heroin use, current cocaine, benzodiazepine and alcohol use on enrollment. Factors associated with ≥1year OBOT retention were identified using generalized estimating equation logistic regression models. Patients who re-enrolled in the program contributed repeated observations. RESULTS: There were 1605 OBOT treatment periods among 1237 patients in this study. Almost half, 45% (717/1605), of all treatment periods were ≥1year and a majority, 53.7% (664/1237), of patients had at least one ≥1year period. In adjusted analyses, female gender (Adjusted Odds Ratio [AOR] 1.55, 95% CI [1.20, 2.00]) psychiatric diagnosis (AOR 1.75 [1.35, 2.27]) and age (AOR 1.19 per 10year increase [1.05, 1.34]) were associated with greater odds of ≥1year retention. Unemployment (AOR 0.72 [0.56, 0.92]), Hepatitis C (AOR 0.59 [0.45, 0.76]), black race/ethnicity (AOR 0.53 [0.36, 0.78]) and Hispanic race/ethnicity (AOR 0.66 [0.48, 0.92]) were associated with lower odds of ≥1year retention. CONCLUSIONS: Over half of patients who presented to Office Based Opioid Treatment with buprenorphine were ultimately successfully retained for ≥1year. However, significant disparities in one-year treatment retention were observed, including poorer retention for patients who were younger, black, Hispanic, unemployed, or with hepatitis C.

Office-Based Opioid Treatment with Buprenorphine (OBOT-B): Statewide Implementation of the Massachusetts Collaborative Care Model in Community Health Centers.

We describe a Massachusetts Bureau of Substance Abuse Services' (BSAS) initiative to disseminate the office-based opioid treatment with buprenorphine (OBOT-B) Massachusetts Model from its development at Boston Medical Center (BMC) to its implementation at fourteen community health centers (CHCs) beginning in 2007. The Massachusetts Collaborative Care Model for the delivery of opioid agonist therapy with buprenorphine, in which nurses working with physicians play a central role in the evaluation and monitoring of patients, holds promise for the effective expansion of treatment for opioid use disorders. The training of and technical assistance for the OBOT nurses as well as a limited program assessment are described. Data spanning 6years (2007-2013) report patient demographics, prior treatment for opioid use disorders, history of overdose, housing, and employment. The expansion of OBOT to the fourteen CHCs increased the number of physicians who were "waivered" (i.e., enabling their prescribing of buprenorphine) by 375%, from 24 to 114, within 3years. During this period the annual admissions of OBOT patients to CHCs markedly increased. Dissemination of the Massachusetts Model of the Office-Based Opioid Treatment with Buprenorphine employing a collaborative care model with a central role for nursing enabled implementation of effective treatment for patients with an opioid use disorder at community health centers throughout Massachusetts while effectively engaging primary care physicians in this endeavor.

Collaborative care of opioid-addicted patients in primary care using buprenorphine: five-year experience.

BACKGROUND: Opioid addiction is a chronic disease treatable in primary care settings with buprenorphine hydrochloride, but this treatment remains underused. We describe a collaborative care model for managing opioid addiction with buprenorphine hydrochloride-naloxone hydrochloride dihydrate sublingual tablets. METHODS: Ours is a cohort study of patients treated for opioid addiction using collaborative care between nurse care managers and generalist physicians in an urban academic primary care practice during a 5-year period. We examine patient characteristics, 12-month treatment success (ie, retention or taper after 6 months), and predictors of successful outcomes. RESULTS: From September 1, 2003, through September 30, 2008, 408 patients with opioid addiction were treated with buprenorphine. Twenty-six patients were excluded from analysis because they left treatment owing to preexisting legal or medical conditions or a need to transfer to another buprenorphine program. At 1 year, 196 of 382 patients (51.3%) underwent successful treatment. Of patients remaining in treatment at 12 months, 154 of 169 (91.1%) were no longer using illicit opioids or cocaine based on urine drug test results. On admission, patients who were older, were employed, and used illicit buprenorphine had significantly higher odds of treatment success; those of African American or Hispanic/Latino race had significantly lower odds of treatment success. These outcomes were achieved with a model that facilitated physician involvement. CONCLUSION: Collaborative care with nurse care managers in an urban primary care practice is an alternative and successful treatment method for most patients with opioid addiction that makes effective use of time for physicians who prescribe buprenorphine.

Treating homeless opioid dependent patients with buprenorphine in an office-based setting.

CONTEXT: Although office-based opioid treatment with buprenorphine (OBOT-B) has been successfully implemented in primary care settings in the US, its use has not been reported in homeless patients. OBJECTIVE: To characterize the feasibility of OBOT-B in homeless relative to housed patients. DESIGN: A retrospective record review examining treatment failure, drug use, utilization of substance abuse treatment services, and intensity of clinical support by a nurse care manager (NCM) among homeless and housed patients in an OBOT-B program between August 2003 and October 2004. Treatment failure was defined as elopement before completing medication induction, discharge after medication induction due to ongoing drug use with concurrent nonadherence with intensified treatment, or discharge due to disruptive behavior. RESULTS: Of 44 homeless and 41 housed patients enrolled over 12 months, homeless patients were more likely to be older, nonwhite, unemployed, infected with HIV and hepatitis C, and report a psychiatric illness. Homeless patients had fewer social supports and more chronic substance abuse histories with a 3- to 6-fold greater number of years of drug use, number of detoxification attempts and percentage with a history of methadone maintenance treatment. The proportion of subjects with treatment failure for the homeless (21%) and housed (22%) did not differ (P = .94). At 12 months, both groups had similar proportions with illicit opioid use [Odds ratio (OR), 0.9 (95% CI, 0.5-1.7) P = .8], utilization of counseling (homeless, 46%; housed, 49%; P = .95), and participation in mutual-help groups (homeless, 25%; housed, 29%; P = .96). At 12 months, 36% of the homeless group was no longer homeless. During the first month of treatment, homeless patients required more clinical support from the NCM than housed patients. CONCLUSIONS: Despite homeless opioid dependent patients' social instability, greater comorbidities, and more chronic drug use, office-based opioid treatment with buprenorphine was effectively implemented in this population comparable to outcomes in housed patients with respect to treatment failure, illicit opioid use, and utilization of substance abuse treatment.