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Addressing Barriers to Care for Substance Use Disorder Pilot Study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06317987
Acronym
ABCSUD Pilot
Enrollment
74
Registered
2024-03-19
Start date
2024-07-09
Completion date
2026-10-31
Last updated
2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol-Related Disorders, Drug Use Disorders, Illicit Drug Use

Keywords

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

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.

Detailed description

The ABC-SUD Pilot was conducted to evaluate feasibility of conducting a larger trial. Specific goals were to a) confirm patient eligibility criteria, b) confirm selection of the primary and secondary outcomes and the approach to measuring them using electronic health record data, c) confirm the feasibility and acceptability of randomization procedures, d) evaluate the feasibility of care navigation protocol delivery by care coordinators, e) evaluate feasibility of electronic health record templates to assist care coordinators when referring patients to care navigators. This pilot also helped refine study implementation needs and statistical analysis plans for the trial. The pilot's recruitment goal was to offer care navigation to patients until a total of 10 patients agreed to care navigation. The investigators conducted post-intervention quality improvement interviews with several enrolled patients to obtain feedback on intervention design to inform changes. To recruit care coordinators for the pilot, mental health treatment access center managers identified 4 care coordinators who volunteered to participate in piloting the care navigator intervention. To maximize the study sample for the larger trial, the pilot evaluated the feasibility of employing a "vanguard" randomization approach, which is a type of stratified randomization in which pilot (or vanguard) care coordinators are pre-randomized to begin piloting the intervention but then retain their randomization status for the subsequent trial. When using the vanguard method, the patient eligibility for the pilot period and trial period are distinct. Clinicians (care coordinators) were eligible if they conduct video or phone-based assessment and treatment planning visits in the mental health treatment access center, had been employed for at least 1 month, had completed trainings related to their clinical role in the health system, were scheduled to conduct at least 3 assessments per day, and consented to participate in the study. Over the course of the pilot, we changed patient eligibility criteria. During the first period of the pilot (07/09/2024 - 09/15/2024), the sample of patients eligible for the pilot analyses included individuals with a visit to an enrolled care coordinator who were ≥ 18 years of age and have a SUD assessment and treatment planning visit with a care coordinator. During the second period of the pilot (09/16/2024 - 11/27/2024), the sample of patients eligible for the pilot analyses included individuals with a visit to an enrolled care coordinator during the patient eligibility period who were ≥ 18 years of age, engaged in substance use, and had a mental health assessment and treatment planning visit with a care coordinator. We switched the eligibility criteria to allow us to determine the feasibility and appropriateness of offering care navigation to people with substance use who were seeking mental health treatment (instead of substance use treatment). Analyses follow an intent-to-treat principle whereby care coordinators are analyzed according to the intervention arm to which they were randomized regardless of the subsequent sequence of events. The patient eligibility period was defined as the period in which patients become eligible for the study (i.e., for inclusion in the analytic sample). This period is anticipated to start within 2 weeks of the clinician's randomization date (to allow for sufficient time for intervention coordinators to be trained). The investigators anticipated that approximately 40 patients would comprise the analytic sample.

Interventions

BEHAVIORALCare Navigation

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.

Sponsors

Kaiser Permanente
Lead SponsorOTHER
Stanford University
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

All study outcomes are extracted from secondary data including electronic health record and healthcare claims databases

Intervention model description

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. Care coordinators randomized to UC + CN were able to offer and refer patients to a care navigator. A waiver of consent was obtained for care coordinator participation in the study.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Clinician (Care Coordinator) Inclusion Criteria: * 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. 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 (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) Patient

Design outcomes

Primary

MeasureTime frameDescription
Rate of Patient Interest in Care NavigationThe day that care navigation was offered (same day)Proportion of patients who agree to a care coordinator's offer to be contacted by a care navigator

Secondary

MeasureTime frameDescription
Feasibility of Patient Consent ProceduresFrom study launch to end of accrual (anticipated 16 weeks; see recruitment goals above)Proportion of patients who consent to the study among those who agree to be contacted by a care navigator

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJoseph E Glass, PhD, MSW

Chestnut Health Systems Inc

Participant flow

Recruitment details

Patients with an eligible visit from 7/9/2024-9/15/2024 through 11/27/2024 per electronic health records. A Waiver of Informed Consent was obtained for care coordinator participation in the study.

Pre-assignment details

Care coordinators are randomly assigned to a study arm,, and patients who visit care coordinators are classified as being part of the arm that their care coordinator was assigned to.

Baseline characteristics

Characteristic
Age, Customized
Age
18-25 years
7 Participants
Age, Customized
Age
26-45 years
39 Participants
Age, Customized
Age
46-64 years
24 Participants
Age, Customized
Age
65-75 years
3 Participants
Age, Customized
Age
76 years or older
1 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
28 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
9 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
4 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Unknown or Not Reported
17 Participants
Race (NIH/OMB)
White
47 Participants
Sex: Female, Male
Female
15 Participants
Sex: Female, Male
Male
26 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 10
other
Total, other adverse events
0 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026