Screening Wizard, Component 1 of iCHART (Integrated Care to Help At-Risk Teens)-Feasibility/Pilot Phase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- Personalized Referral
研究概览
简要总结
Screening Wizard (SW). Primary Care Providers (PCPs) are often uncertain about how to best refer adolescents who screen positive for depression or suicidality. Screen-positive youth who are either not in treatment, or express dissatisfaction with current treatment will be consented by an on-site research assistant (RA). Those parents and patients receiving SW will answer additional questions: adaptive screens developed in a previous NIMH study (MH100155) for suicidal risk, anxiety, and mania; perceived barriers; and preferences about treatment. SW generates recommendations for PCPs reflecting patient clinical needs and preferences.
详细描述
Screening Wizard will be delivered by Primary Care Providers (PCPs) at well child visits, beginning with screening occurring within the waiting room which will yield decision support guidance delivered and followed by the PCP at that same visit.
This study utilized an open trial design. A stepped wedge design was originally proposed and efforts were made to adhere to this study design, however after a year of low recruitment and resultant recruitment sites pulling out the of the study, the overall study design was changed to an open trial. Additional recruitment sites were onboarded to the study and provided with the intervention arm in order to obtain feasibility data on the intervention components of the study. For reference a stepped wedge design involves the sequential random rollout of an intervention over two time periods. Following a baseline period in which no clusters (=practices) are exposed to the intervention, the crossover is typically in one direction, from control to intervention and continues until both of the clusters have crossed-over to receive the intervention, with observations taken from each cluster and at each time period.
Hypothesis
The use of Screening Wizard will increase the rate of personalized referrals experts in specialty mental health would provide, compared to Treatment as usual (TAU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Outcome assessors will be masked to the intervention condition at follow-up assessment timepoints.
入排标准
- 年龄范围
- 12 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Youth aged 12-26 yo
- •Biological or adoptive parent is willing to provide informed consent for teen to participate
- •Youth speaks and understands English
排除标准
- •Non English speaking
- •No parent willing to provide informed consent
- •Is currently experiencing acute mania or psychosis, evidence of an intellectual or developmental disorder (IDD), life threatening medical condition that requires immediate treatment, or other cognitive or medical condition preventing youth from understanding study and/or participating.
研究组 & 干预措施
Screening Wizard
Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.
干预措施: Screening Wizard (Behavioral)
结局指标
主要结局
Personalized Referral
时间窗: Baseline (in office) visit
The rate of personalized referrals by primary care providers and treatment initiation among adolescents who screen positive for depression or suicidal ideation will be monitored to determine if provider made referral as recommended on intervention report. This initial outcome has been modified as a result of the changes in study design.
次要结局
- Usability & Satisfaction(At exit interview after Baseline phone visit. The baseline visit occurs 24-48 hours after initial screening and the exit interview call will be made within 1 month following the completion of the baseline phone assessment.)
- Number of Participants Who Utilized the Screening Wizard Application(Baseline (phone) visit)
- Service Use (Number of Participants at Baseline)(At Baseline phone visit)
- Service Use (Number of Participants at 12 Week Follow-up)(Week 12 follow up after Baseline)
- Service Use (Number of Participants at 4 Week Follow-up)(Week 4 follow-up after Baseline)
- Cost Analysis: Cost of Screening Wizard Intervention at Baseline(At Baseline)
研究者
Oliver Lindhiem
Associate Professor of Psychiatry
University of Pittsburgh