Clinics Optimizing MEthadone Take-homes for opioid use disorder (COMET): Protocol for a stepped-wedge randomized trial to facilitate clinic level changes.

INTRODUCTION: Regulatory changes made during the COVID-19 public health emergency (PHE) that relaxed criteria for take-home dosing (THD) of methadone offer an opportunity to improve quality of care with a lifesaving treatment. There is a pressing need for research to study the long-term effects of the new PHE THD rules and to test data-driven interventions to promote more effective adoption by opioid treatment programs (OTPs). We propose a two-phase project to develop and test a multidimensional intervention for OTPs that leverages information from large State administrative data. METHODS AND ANALYSIS: We propose a two-phased project to develop then test a multidimensional OTP intervention to address clinical decision making, regulatory confusion, legal liability concerns, capacity for clinical practice change, and financial barriers to THD. The intervention will include OTP THD specific dashboards drawn from multiple State databases. The approach will be informed by the Health Equity Implementation Framework (HEIF). In phase 1, we will employ an explanatory sequential mixed methods design to combine analysis of large state administrative databases-Medicaid, treatment registry, THD reporting-with qualitative interviews to develop and refine the intervention. In phase 2, we will conduct a stepped-wedge trial over three years with 36 OTPs randomized to 6 cohorts of a six-month clinic-level intervention. The trial will test intervention effects on OTP-level implementation outcomes and patient outcomes (1) THD use; 2) retention in care; and 3) adverse healthcare events). We will specifically examine intervention effects for Black and Latinx clients. A concurrent triangulation mixed methods design will be used: quantitative and qualitative data collection will occur concurrently and results will be integrated after analysis of each. We will employ generalized linear mixed models (GLMMs) in the analysis of stepped-wedge trials. The primary outcome will be weekly or greater THD. The semi-structured interviews will be transcribed and analyzed with Dedoose to identify key facilitators, barriers, and experiences according to HEIF constructs using directed content analysis. DISCUSSION: This multi-phase, embedded mixed methods project addresses a critical need to support long-term practice changes in methadone treatment for opioid use disorder following systemic changes emerging from the PHE-particularly for Black and Latinx individuals with opioid use disorder. By combining findings from analyses of large administrative data with lessons gleaned from qualitative interviews of OTPs that were flexible with THD and those that were not, we will build and test the intervention to coach clinics to increase flexibility with THD. The findings will inform policy at the local and national level.

Scale-Up Study Protocol of the Implementation of a Mobile Health SBIRT Approach for Alcohol Use Reduction in Mozambique.

BACKGROUND: Hazardous drinking imposes a major public health burden worldwide, especially in low-income countries such as Mozambique. Implementation of the Screening, Brief Intervention, Referral to Treatment (SBIRT) approach to address problem drinking is recommended. However, evidence regarding the best strategies to implement SBIRT at scale is needed. METHODS: Guided by the Reach Effectiveness Adoption Implementation Maintenance model, the authors will conduct a 2-year, cluster-randomized, hybrid type-2 implementation-effectiveness trial in 12 districts in Mozambique evaluating implementation, clinical effectiveness, outcomes, and cost. Eight districts will be randomly assigned to a mobile application-based health SBIRT condition and four to SBIRT-Conventional Training and Supervision. Interventions will be delivered by clinic-based community health workers. The Consolidated Framework for Implementation Research will guide the authors' mixed-methods assessments throughout the study. RESULTS: The study arm showing better cost-effectiveness will be scaled up in the other arms' districts. During this 12-month scale-up phase, Ministry of Health personnel will be charged with providing training, clinical activities, and supervision in all 12 districts without research team support. The SBIRT scale-up phase is critical to identify facilitators and barriers for tracking internal and external factors in clinics that continue using the superior arm and those that switch to it. NEXT STEPS: In a multistep process with stakeholders from multiple sectors, outcomes and lessons learned from this study will inform the development of an implementation tool kit to guide SBIRT scale-up of community services addressing hazardous drinking in other low- and middle-income countries and low-resource settings in high-income countries.

A facilitation model for implementing quality improvement practices to enhance outpatient substance use disorder treatment outcomes: a stepped-wedge randomized controlled trial study protocol.

BACKGROUND: The misuse of and addiction to opioids is a national crisis that affects public health as well as social and economic welfare. There is an urgent need for strategies to improve opioid use disorder treatment quality (e.g., 6-month retention). Substance use disorder treatment programs are challenged by limited resources and a workforce that does not have the requisite experience or education in quality improvement methods. The purpose of this study is to test a multicomponent clinic-level intervention designed to aid substance use disorder treatment clinics in implementing quality improvement processes to improve high-priority indicators of treatment quality for opioid use disorder. METHODS: A stepped-wedge randomized controlled trial with 30 outpatient treatment clinics serving approximately 2000 clients with opioid use disorder each year will test whether a clinic-level measurement-driven, quality improvement intervention, called Coaching for Addiction Recovery Enhancement (CARE), improves (a) treatment process quality measures (use of medications for opioid use disorder, in-treatment symptom and therapeutic progress, treatment retention) and (b) recovery outcomes (substance use, health, and healthcare utilization). The CARE intervention will have the following components: (1) staff clinical training and tools, (2) quality improvement and change management training, (3) external facilitation to support implementation and sustainability of quality improvement processes, and (4) an electronic client-reported treatment progress tool to support data-driven decision making and clinic-level quality measurement. The study will utilize multiple sources of data to test study aims, including state administrative data, client-reported survey and treatment progress data, and staff interview and survey data. DISCUSSION: This study will provide the field with a strong test of a multicomponent intervention to improve providers' capacity to make systematic changes tied to quality metrics. The study will also result in training and materials that can be shared widely to increase quality improvement implementation and enhance clinical practice in the substance use disorder treatment system. TRIAL REGISTRATION: Trial # NCT04632238NCT04632238 registered at clinicaltrials.gov on 17 November 2020.