Addressing Barriers to Care for Substance Use Disorder Pilot Study (Center for Dissemination and Implementation At Stanford, Research Component #3)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Rate of patient interest in care navigation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
All study outcomes are extracted from secondary data including electronic health record and healthcare claims databases
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 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.
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 (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)
研究组 & 干预措施
Care Navigation (pilot)
Mental health care coordinators 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 (pilot)
Mental health care coordinators offer substance use resources and treatment options to patients as usual
结局指标
主要结局
Rate of patient interest in care navigation
时间窗: From pilot study launch to end of accrual (anticipated 16 weeks; see recruitment goals above)
Proportion of patients who agree to a care coordinator's offer to be contacted by a care navigator
Rate of Patient Interest in Care Navigation
时间窗: The 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
次要结局
- Feasibility of patient consent procedures(From study launch to end of accrual (anticipated 16 weeks; see recruitment goals above))
- Feasibility of Patient Consent Procedures(From study launch to end of accrual (anticipated 16 weeks; see recruitment goals above))
研究者
Joseph Glass
Senior Research Scientist
Chestnut Health Systems