TY - JOUR AU - T. E. Matson AU - M. A. Navarro AU - A. Idu AU - J. F. Bobb AU - B. M. Patrick AU - R. Phillips AU - T. D. Barrett AU - F. S. Rossi AU - N. Krawczyk AU - R. Doud AU - K. Rogers AU - C. J. Davis AU - R. Caldeiro AU - J. E. Glass A1 - AB - 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. AD - Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Ste. 1300, Seattle, WA, 98101, USA. tessa.e.matson@kp.org.; Center for Dissemination and Implementation at Stanford, Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Palo Alto, USA.; Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Ste. 1300, Seattle, WA, 98101, USA.; Center for Opioid Epidemiology and Policy, Department of Population Health, New York University Grossman School of Medicine, New York, USA.; Kaiser Permanente Washington Mental Health and Wellness Service, Seattle, USA.; Lighthouse Institute, Chestnut Health Systems, Eugene, USA. AN - 41035041 BT - Addict Sci Clin Pract C5 - Opioids & Substance Use CP - 1 DA - Oct 1 DO - 10.1186/s13722-025-00605-7 DP - NLM ET - 20251001 IS - 1 JF - Addict Sci Clin Pract LA - eng N2 - 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. PY - 2025 SN - 1940-0632 (Print); 1940-0632 SP - 78 ST - 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 T1 - 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 T2 - Addict Sci Clin Pract TI - 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 U1 - Opioids & Substance Use U3 - 10.1186/s13722-025-00605-7 VL - 20 VO - 1940-0632 (Print); 1940-0632 Y1 - 2025 ER -