Continuum of care in hospitalized patients with opioid or stimulant use disorder and infectious complications of drug use-substance use/infectious disease integrated clinic compared to treatment as usual to prevent infection-related readmission (CHOICE-STAR): a study protocol for an effectiveness-implementation randomized controlled trial.

BACKGROUND: People who inject drugs (PWID) experience high rates of serious injection-related bacterial and fungal infections (SIRI), including cellulitis, osteomyelitis, and endocarditis. These infections often require prolonged antibiotic treatment and result in frequent rehospitalizations, with over 50% of patients readmitted within 1 year. Few evidence-based interventions exist to optimize continuity of care for addiction, management, and prevention of SIRI following hospitalization.

METHODS: CHOICE-STAR is a hybrid type 1 randomized effectiveness-implementation trial, guided by the Exploration, Preparation, Implementation, and Sustainment Framework (EPIS), conducted at five hospitals across the USA. The study aims to assess the effectiveness of the integrated infectious diseases (ID) and substance use disorder (SUD) outpatient clinic on 6-month infection-related rehospitalization among people hospitalized with an infection related to injecting opioids or stimulants. The study also includes implementation outcomes guided by Proctor's Implementation Outcomes taxonomy, as well as cost-effectiveness outcomes. The integrated clinic (IC) will offer facilitated linkage to a clinic providing medical care aimed at treating SUD and ID by completing treatment for the index infection, treating existing ID complications of SUD, and preventing subsequent infections by providing low barrier care for SUD including medication for OUD (MOUD) and harm reduction integrated into a single appointment and co-located at a single site for a minimum of monthly appointments over a 6 month time period. An additional 6 months' follow-up will be included to assess outcomes following the completion of the intervention. The IC includes a weekly care coordination meeting between the ID and SUD providers. The study will enroll approximately 304 participants.

DISCUSSION: This trial addresses a critical gap in post-hospitalization care for PWID with SIRI. If effective, the integrated care model could significantly reduce rehospitalizations, improve treatment completion, and provide a replicable framework for healthcare systems. The study's implementation science components will inform the scalability and sustainability of this intervention. Results will inform evidence-based policy and practice recommendations for managing this high-risk population, potentially leading to improved patient health outcomes.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06513156 . Registered on August 09, 2024.