NCT06729957

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Dec 2024Aug 2026

First Submitted

Initial submission to the registry

December 9, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

December 16, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

December 9, 2024

Last Update Submit

February 24, 2026

Conditions

Keywords

Implementation ScienceCare NavigationDrug Use DisordersQuality ImprovementBehavioral Health

Outcome Measures

Primary Outcomes (1)

  • Engagement in treatment for substance use disorder

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

    48 days

Secondary Outcomes (1)

  • Initiation of treatment for substance use disorder

    30 days

Study Arms (2)

Care Navigation

EXPERIMENTAL

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.

Behavioral: Care Navigation

Services as Usual

NO INTERVENTION

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

Interventions

Care NavigationBEHAVIORAL

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.

Care Navigation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Washington

Seattle, Washington, 98101, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Substance-Related DisordersAlcohol-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Joseph E Glass, PhD, MSW

    Chestnut Health Systems

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All study outcomes are extracted from electronic health records and healthcare claims data that cannot be manipulated by the study team.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Investigator

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 12, 2024

Study Start

December 16, 2024

Primary Completion (Estimated)

August 21, 2026

Study Completion (Estimated)

August 21, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

This study protocol is embedded within a Center of Excellence funded by the National Institute on Drug Abuse. In coordination with other center project components, the study protocol will be submitted for publication to either an addiction or implementation science journal. Additional data (analytic code) can be requested from the Principal Investigator. Participant data will be shared with the prime site as allowed. Analysis files will be constructed from the electronic data and aggregated. No names, addresses, telephone numbers, email addresses, medical record numbers, etc. will be retained in the aggregated files.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Anticipated 1/1/2027-12/31/2030
Access Criteria
Plans for data access will be determined in conjunction with the prime site

Locations