Addressing Barriers to Care for Substance Use Disorder Pilot Study

NCT06317987 | Active Not Recruiting

• 2 other identifiers: 2068557P50DA054072
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The Addressing Barriers to Care for Substance Use Disorder Pilot (ABC-SUD Pilot) was a randomized pilot study that preceded a larger trial. The ABC-SUD Pilot was a parallel group, cluster-randomized pilot feasibility trial, with clinicians (care coordinators) as the unit of randomization. This study was conducted in a mental health treatment access center within the Washington region of Kaiser Permanente. As part of usual care, patients contacted the mental health access center to speak to a "care coordinator" to obtain contact information for potential venues to obtain treatment for substance use disorder. The experimental intervention, Care Navigation, was evaluated for its potential to increase the utilization of substance use disorder treatment among patients who contacted the mental health treatment access center. The investigators note that Care Navigation was delivered by study "care navigators", who were distinct from the health system's care coordinators.

Conditions

Drug Use Disorders; Illicit Drug Use; Alcohol-Related Disorders

Keywords

Implementation Science; Care Navigation; Drug Use Disorders; Quality Improvement; Behavioral Health

Outcome Measures

Primary Outcomes (1)

• Rate of patient interest in care navigation

  Proportion of patients who agree to a care coordinator's offer to be contacted by a care navigator

  From pilot study launch to end of accrual (anticipated 16 weeks; see recruitment goals above)

Secondary Outcomes (1)

• Feasibility of patient consent procedures

  From study launch to end of accrual (anticipated 16 weeks; see recruitment goals above)

Other Outcomes (7)

• SUD treatment - 30 days

  Time Frame: From patient's clinical assessment appointment to 30 days later

• SUD treatment - 60 days

  Time Frame: From patient's clinical assessment appointment to 60 days later

• SUD treatment - 90 days

  Time Frame: From patient's clinical assessment appointment to 90 days later

Study Arms (2)

Care Navigation (pilot)

EXPERIMENTAL

Mental health care coordinators 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 (pilot)

NO INTERVENTION

Mental health care coordinators offer substance use resources and treatment options to patients as usual

Interventions

Care Navigation BEHAVIORAL

Care navigation is an intervention that seeks to help patients follow up on substance use treatment plans that are established by care coordinators in the health system by reducing barriers to accessing treatment. This includes advocating for patients to reduce disparities based on language, income or geographical barriers, and cultural preferences (i.e., linkage to available services); and using motivational enhancement techniques to help patients maintain their motivation to obtain substance use treatment while working through these barriers (i.e., motivational intervention). Thus, the care navigator's role is to take the care plan developed between the patient and the mental health care coordinator forward and connect the patient to available services and provide motivational enhancement techniques to help direct the patient toward completion of the care plan.

Care Navigation (pilot)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Conducts video or phone-based assessment and treatment planning visits in the mental health treatment access center
• Has been employed for at least 1 month and has completed trainings related to their clinical role in the health system
• Scheduled to conduct at least 3 assessments per day
• Has consented to participate in the study.

You may not qualify if:

• \- None
• 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 (this criterion was applied during the first period of the pilot, 7/9/2024-9/15/2024)
• Has evidence of substance use as determined by the care coordinator (this criterion was applied during the second period of the pilot, 9/16/2024-11/27/2024)
• Has an assessment and treatment planning visit for mental health treatment with an enrolled care coordinator (this criterion was applied during the second period of the pilot, 9/16/2024-11/27/2024)
• 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 or Medicaid insurance (anticipated incomplete capture of covariate and/or outcome information)

Sponsors & Collaborators

• Kaiser Permanente: lead
• Stanford University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Kaiser Permanente Washington

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Alcohol-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Joseph E Glass, PhD, MSW

  Chestnut Health Systems Inc

  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 secondary data including electronic health record and healthcare claims databases
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Investigator

Model Details: Care coordinators were randomized to two parallel groups: usual care (UC; i.e., the comparator group) and usual care plus care navigation (UC + CN; i.e., the experimental group). All care coordinators continued offering substance use resources and treatment options to patients as usual. Clinicians randomized to UC + CN were able to offer and refer patients to a care navigator.

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: July 9, 2024
• Primary Completion: February 11, 2025
• Study Completion: December 2, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: To be determined
• Access Criteria: Access criteria will be determined by Kaiser Permanente and Stanford University

Locations

US (1)