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Active, Not Recruiting

NCT Number: NCT06729957

Addressing Barriers to Care for Substance Use Disorder Trial

The Addressing Barriers to Care for Substance Use Disorder Trial (ABC-SUD) is a cluster-randomized crossover trial, with clinicians (care coordinators) as the unit of randomization.

This study will be conducted in a mental health access center within the Washington region of Kaiser Permanente. As part of usual care, patients contact the mental health access center and speak to a care coordinator to obtain an appointment with or contact information for potential venues to obtain treatment for substance use disorder.

The experimental intervention, Care Navigation, will be evaluated for its potential to increase engagement in substance use disorder treatment among patients who contact the mental health access center. Care Navigation will be delivered by study care navigators, who are distinct from the health system's care coordinators.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Washington

Seattle, Washington, 98101, United States

About this study

The ABC-SUD Trial is a cluster-randomized crossover trial evaluating the effectiveness of care navigation in increasing engagement in substance use disorder treatment. Each care coordinator is randomly assigned to a study arm (services as usual or care navigation) at the beginning of the trial (period 1), and halfway through the trial, switches to the other study arm (period 2). The patient population includes individuals who are seeking substance use treatment and are evaluated by enrolled care coordinators.

During periods in which care coordinators are assigned to the intervention arm, care coordinators offer care navigation to patients and utilize an electronic health record referral tool to refer patients to care navigators. This tool is disabled for care coordinators during the period in which they are assigned to the control arm.

This study will employ an encouragement design, where patients who speak with intervention care coordinators are offered care navigation, but patients choose whether to participate in care navigation. Primary analyses will follow an intent-to-treat principle whereby care coordinators and patients will be analyzed according to the intervention arm to which they are assigned regardless of the subsequent sequence of events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Clinician (Care Coordinator) Inclusion Criteria:

  • Conducts assessment and treatment planning visits in the mental health access center
  • Has been employed for at least 1 month
  • Has completed trainings related to their clinical role in the health system
  • Scheduled to conduct assessments

Clinician Exclusion Criteria: None

Patient Inclusion Criteria (eligibility for analyses):

  • Visits an enrolled care coordinator during the patient eligibility period
  • ≥ 18 years of age at the time of the visit
  • Has an assessment and treatment planning visit for SUD with an enrolled care coordinator

Patient Exclusion Criteria:

  • Patients who have requested through the health system to opt out of research contact or chart review
  • Patients who are not enrolled in Kaiser Permanente insurance, or those only enrolled in Medicaid (anticipated incomplete capture of covariate and/or outcome information)

Treatment and study plan

care navigation

Behavioral

Care navigation is an intervention that seeks to help patients engage in substance use treatment by increasing motivation and reducing barriers to accessing treatment. The care navigator helps the patient engage in the treatment plan established by the mental health care coordinator.

Primary outcomes

  1. Engagement in treatment for substance use disorder

    Time frame: 48 days

    Completion of ≥ 3 treatment visits for substance use disorder within 48 days of their assessment visit

Secondary outcomes

  1. Initiation of treatment for substance use disorder

    Time frame: 30 days

    Completion of ≥ 1 treatment visit for substance use disorder within 30 days of their assessment visit

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • Stanford University

Registry information

Official study title

Addressing Barriers to Care for Substance Use Disorder Trial (Center for Dissemination and Implementation At Stanford, Research Component #3)

Acronym: ABC-SUD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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