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

• Published in: PloS one 2023-06, Vol.18 (6), p.e0286859
• Main Authors: Choi, Sugy, O'Grady, Megan A, Cleland, Charles M, Knopf, Elizabeth, Hong, Sueun, D'Aunno, Thomas, Bao, Yuhua, Ramsey, Kelly S, Neighbors, Charles J
• Format: Article
• Language: English
• Subjects: Analgesics, Opioid - therapeutic use; Care and treatment; Clinical medicine; Clinical trials; Confidentiality; Content analysis; COVID-19; Data collection; Decision making; Dosage and administration; Drug abuse; Drug addiction; Drug overdose; Flexibility; Government programs; Health aspects; Health services; Humans; Intervention; Legal liability; Long-term effects; Medical care; Medicine and Health Sciences; Methadone; Methadone - therapeutic use; Methadone hydrochloride; Mortality; Narcotics; Opioid-Related Disorders - drug therapy; Opioids; Patients; Public health; Qualitative analysis; Qualitative research; Quality management; Randomized Controlled Trials as Topic; Research and Analysis Methods; Research Design; Social Sciences; Statistical models; Study Protocol; Substance use disorder; Systems stability; Triangulation
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0286859

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. 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. 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 administ