Addressing Barriers to Care for Substance Use Disorder Trial

NCT ID: NCT06729957

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-16

Study Completion Date

2026-08-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Drug Use Disorders Alcohol-Related Disorders Substance Use Disorder (SUD)

Keywords

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Implementation Science Care Navigation Drug Use Disorders Quality Improvement Behavioral Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Care coordinators will be randomized to care navigation arm or services as usual arm at study outset and switch to the opposite arm halfway through the study.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
All study outcomes are extracted from electronic health records and healthcare claims data that cannot be manipulated by the study team.

Study Groups

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Care Navigation

Mental health care coordinators are able to offer and refer patients to a care navigator in addition to offering substance use resources and treatment options as usual.

Group Type EXPERIMENTAL

Care Navigation

Intervention Type 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.

Services as Usual

Mental health care coordinators will continue offering substance use resources and treatment options to patients as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Care Navigation

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* 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

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Joseph Glass

Senior Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph E Glass, PhD, MSW

Role: PRINCIPAL_INVESTIGATOR

Chestnut Health Systems

Locations

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Kaiser Permanente Washington

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tara Beatty, MA

Role: CONTACT

Phone: 206-442-4012

Email: [email protected]

Theresa E Matson, PhD

Role: CONTACT

Phone: 206-442-4012

Email: [email protected]

Facility Contacts

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Tara Beatty, MA

Role: primary

Theresa E Matson, PhD MPH

Role: backup

References

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Matson TE, Navarro MA, Idu A, Bobb JF, Patrick BM, Phillips R, Barrett TD, Rossi FS, Krawczyk N, Doud R, Rogers K, Davis CJ, Caldeiro R, Glass JE. 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. Addict Sci Clin Pract. 2025 Oct 1;20(1):78. doi: 10.1186/s13722-025-00605-7.

Reference Type DERIVED
PMID: 41035041 (View on PubMed)

Other Identifiers

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P50DA054072

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2068557T

Identifier Type: -

Identifier Source: org_study_id