跳至主要内容
临床试验/NCT06729957
NCT06729957招募中不适用

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

Kaiser Permanente1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2024年12月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
360
试验地点
1
主要终点
Engagement in treatment for substance use disorder

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Clinician (Care Coordinator) 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

排除标准

  • •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
  • •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 insurance, or those only enrolled in Medicaid (anticipated incomplete capture of covariate and/or outcome information)

研究组 & 干预措施

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.

干预措施: Care Navigation (Behavioral)

Services as Usual

No Intervention

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

结局指标

主要结局

Engagement in treatment for substance use disorder

时间窗: 48 days

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

次要结局

  • Initiation of treatment for substance use disorder(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph Glass

Senior Investigator

Chestnut Health Systems

研究点 (1)

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