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.
Theresa E Matson, Mia A Navarro, Abisola Idu, Jennifer F Bobb, Briana M Patrick, Rebecca Phillips, Tyler D Barrett, Fernanda S Rossi, Noa Krawczyk, Rachael Doud, Kristine Rogers, Chayna J Davis, Ryan Caldeiro, Joseph E Glass
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引用次数: 0
Abstract
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.
期刊介绍：
Addiction Science & Clinical Practice provides a forum for clinically relevant research and perspectives that contribute to improving the quality of care for people with unhealthy alcohol, tobacco, or other drug use and addictive behaviours across a spectrum of clinical settings.
Addiction Science & Clinical Practice accepts articles of clinical relevance related to the prevention and treatment of unhealthy alcohol, tobacco, and other drug use across the spectrum of clinical settings. Topics of interest address issues related to the following: the spectrum of unhealthy use of alcohol, tobacco, and other drugs among the range of affected persons (e.g., not limited by age, race/ethnicity, gender, or sexual orientation); the array of clinical prevention and treatment practices (from health messages, to identification and early intervention, to more extensive interventions including counseling and pharmacotherapy and other management strategies); and identification and management of medical, psychiatric, social, and other health consequences of substance use.
Addiction Science & Clinical Practice is particularly interested in articles that address how to improve the quality of care for people with unhealthy substance use and related conditions as described in the (US) Institute of Medicine report, Improving the Quality of Healthcare for Mental Health and Substance Use Conditions (Washington, DC: National Academies Press, 2006). Such articles address the quality of care and of health services. Although the journal also welcomes submissions that address these conditions in addiction speciality-treatment settings, the journal is particularly interested in including articles that address unhealthy use outside these settings, including experience with novel models of care and outcomes, and outcomes of research-practice collaborations.
Although Addiction Science & Clinical Practice is generally not an outlet for basic science research, we will accept basic science research manuscripts that have clearly described potential clinical relevance and are accessible to audiences outside a narrow laboratory research field.
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