跳至主要内容
临床试验/NCT06311591
NCT06311591Enrolling By Invitation不适用

Evaluation of Efficacy, Effectiveness, and Implementation of Jaspr Health's Digital Platform in Emergency Department for Patients With Suicidal Risk - Part B: Real-World Study (RWS)

University of Massachusetts, Worcester8 个研究点 分布在 1 个国家目标入组 27,908 人开始时间: 2024年11月7日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
27,908
试验地点
8
主要终点
Suicide composite, binary

研究概览

简要总结

This Study will evaluate the implementation of a multi-component suicide prevention technology (Jaspr Health) that facilitates delivery of suicided-related evidence-based practices (EBPs) while replacing wasted waiting time with productive time in the Emergency Departments (EDs). The EBPs satisfy several key performance elements for systems adopting Zero Suicide.

A Complementary Randomized Controlled Trial and Real-World Study for Efficacy, Effectiveness, and Implementation Study Design (CREID) will be used

详细描述

This study will evaluate Jaspr's patient-facing tablet-based application (app) during suicide-related ED visits. The app guides patients in completing the Suicide Status Interview, which comprises of evidence-based CAMS certified suicide prevention tools such as a suicide risk assessment, Stanley Brown- inspired safety plan, and lethal means safety counseling. It also offers access to a menu of "Comfort and Skills" modules that teaches patients behavioral skills to effectively manage imminent distress, while shared stories offer a library of professionally produced, racially and culturally diverse, inspirational videos of people with suicide-centered lived experience.

Subjects who engage with Jaspr can continue to access their safety plan, comfort and coping skills exercises, and the video library via Jaspr at Home (JAH) mobile application; a summary of the self-administered risk assessment is shared with the clinical team directly through the patient electronic health record to help guide the treatment plan.

Part A of the study will be a Randomized Controlled Trial (RCT) to evaluate the efficacy and mechanism of action of Jaspr's app intervention in EDs. It is reported in a separate CTG protocol (Unique Protocol ID: STUDY00000716 Part A)

This CTG protocol describes Part B of the study, which will be a Real-World Study (RWS) to evaluate the effectiveness and implementation processes in EDs and outcomes. Two health systems affiliated with Ohio State University and the University of Colorado will implement Jaspr as part of routine clinical care. Each health system will implement Jaspr in two diverse EDs: one major academic site, and one community site. Each system will collect data on eligible patients across two Phases: (1) a retrospective enhanced treatment as usual (ETAU) phase comprising 12 months of index ED visits with a 12 month follow-up window, and (2) an Implementation/Intervention phase comprising 18 months of index ED visits with a 12 month follow-up window. Eligible patients will be defined as individuals 18 years or older who present to the ED in the designated date ranges and who screen positive for suicide risk on an evidence based screener administered clinically.

Data for all eligible patients across both phases will be collected. Data sources will be electronic health records (EHR) and state death registries. Data related to the index ED visit and all acute care visits within a 12 month follow-up window of the index visit will be collected. A limited dataset with personal identifiers removed will be shared with UMass Chan Medical School for harmonization and analyses.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • >= 18 years old
  • Positive for suicide risk on screener
  • Reads English, or has proxy available to read and enter questions

排除标准

  • Cognitively or emotionally incapable of engaging with Jaspr

结局指标

主要结局

Suicide composite, binary

时间窗: 12 months post enrollment

Death by suicide OR suicide-related acute care utilization within 12 months after enrollment

次要结局

未报告次要终点

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Edwin Boudreaux

Professor

University of Massachusetts, Worcester

研究点 (8)

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