Addressing Barriers to Care for Substance Use Disorder Pilot Study (NCT06317987) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Addressing Barriers to Care for Substance Use Disorder Pilot Study
United States74 participantsStarted 2024-07-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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 or Medicaid insurance (anticipated incomplete capture of covariate and/or outcome information)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of patient interest in care navigation
Timeframe: From pilot study launch to end of accrual (anticipated 16 weeks; see recruitment goals above)