Addiction science & clinical practice · 2025
Design of a cluster-randomized, hybrid type 1 effectiveness-implementation trial of a care navigation intervention to increase substance use disorder treatment engagement: study protocol.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
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Matson Theresa E, Navarro Mia A, Idu Abisola, Bobb Jennifer F, Patrick Briana M, Phillips Rebecca, Barrett Tyler D, Rossi Fernanda S, Krawczyk Noa, Doud Rachael, Rogers Kristine, Davis Chayna J, Caldeiro Ryan, Glass Joseph E
Аннотация
BACKGROUND: Practical and motivational barriers can deter people from engaging in substance use disorder (SUD) treatment, even those who seek treatment. Care navigation is a psychosocial intervention that seeks to facilitate patients' timely access to care by identifying and intervening upon barriers. Few trials have tested the effectiveness of care navigation when embedding in real-world healthcare, and no trials have studied the process of implementing care navigation into clinical practice. This protocol describes a study that will evaluate whether care navigation can increase treatment engagement among patients seeking SUD treatment.
METHODS: The Addressing Barriers to Care for Substance Use Disorder (ABC-SUD) study is a hybrid type I cluster-randomized effectiveness-implementation trial. It is conducted in a mental health access center of an integrated healthcare system in Washington state. Within this center, licensed mental health clinicians assess patient needs and use shared decision-making to establish SUD treatment plans for patients (usual care). This study tests whether an added care navigation intervention can improve patient engagement in SUD treatment. Care navigation begins after a treatment plan is made and provides up to 7 weeks of support focused on enhancing patient motivation to initiate and engage in treatment, problem-solving barriers (e.g., transportation logistics), and accommodating patient preferences (e.g., preferred language of care, cultural preferences). This trial uses a two period, two sequence crossover design. Clinicians are randomized to offer care navigation to patients during the first or second study period (i.e., clinicians are assigned to an initial study condition and switch conditions halfway through the trial). Care navigation is implemented with several strategies: leadership engagement, clinical workflow specifications, electronic health record (EHR) tools, training, performance improvement, and electronic learning collaborative. The primary outcome-obtained from EHRs and insurance claims-is engagement in SUD treatment, defined as ≥3 SUD treatment visits within 48 days of a treatment plan. This study uses standardized measures of implementation climate and outcomes to examine mechanisms with which the intervention strategies exert their impact on implementation and effectiveness outcomes.
DISCUSSION: The ABC-SUD study will test whether care navigation improves SUD treatment engagement while concurrently generating information about its implementation in healthcare.
TRIAL REGISTRATION: This study was prospectively registered at www.
CLINICALTRIALS: gov (NCT06729957) on December 9, 2024.
METHODS: The Addressing Barriers to Care for Substance Use Disorder (ABC-SUD) study is a hybrid type I cluster-randomized effectiveness-implementation trial. It is conducted in a mental health access center of an integrated healthcare system in Washington state. Within this center, licensed mental health clinicians assess patient needs and use shared decision-making to establish SUD treatment plans for patients (usual care). This study tests whether an added care navigation intervention can improve patient engagement in SUD treatment. Care navigation begins after a treatment plan is made and provides up to 7 weeks of support focused on enhancing patient motivation to initiate and engage in treatment, problem-solving barriers (e.g., transportation logistics), and accommodating patient preferences (e.g., preferred language of care, cultural preferences). This trial uses a two period, two sequence crossover design. Clinicians are randomized to offer care navigation to patients during the first or second study period (i.e., clinicians are assigned to an initial study condition and switch conditions halfway through the trial). Care navigation is implemented with several strategies: leadership engagement, clinical workflow specifications, electronic health record (EHR) tools, training, performance improvement, and electronic learning collaborative. The primary outcome-obtained from EHRs and insurance claims-is engagement in SUD treatment, defined as ≥3 SUD treatment visits within 48 days of a treatment plan. This study uses standardized measures of implementation climate and outcomes to examine mechanisms with which the intervention strategies exert their impact on implementation and effectiveness outcomes.
DISCUSSION: The ABC-SUD study will test whether care navigation improves SUD treatment engagement while concurrently generating information about its implementation in healthcare.
TRIAL REGISTRATION: This study was prospectively registered at www.
CLINICALTRIALS: gov (NCT06729957) on December 9, 2024.