Evaluation of Efficacy, Effectiveness, and Implementation of Jaspr Health's Digital Platform in Emergency Department for Patients With Suicidal Risk- Part A: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 670
- 试验地点
- 1
- 主要终点
- Suicide composite, binary
研究概览
简要总结
This Study will comprehensively evaluate 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 comprise of an evidence-based Collaborative Assessment & Management of Suicidality (CAMS) certified suicide prevention tools such as a suicide risk assessment, Stanley Brown- inspired safety planning, 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 interact 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 medical record to help guide the treatment plan.
Part A of the study will be an individual, patient-level Randomized Controlled Trial (RCT) to evaluate the efficacy and mechanism of action of Jaspr's app intervention in EDs. All subjects will complete a baseline assessment prior to random assignment to one of the the two study conditions. All subjects will receive follow-up phone calls for 12 months after enrollment at weeks 6, 12, 24, 36, and 52. These calls will assess suicide related outcomes and healthcare utilization. In addition, the Massachusetts Department of Public Health (MA DPH) death registry will be reviewed, and each subject's electronic health record will be reviewed.
Part B of the study will be a Real-World Study (RWS) to evaluate the effectiveness and implementation processes in EDs and outcomes.
This ClinicalTrials.gov record will cover only Part A. Part B is summarized in a separate entry.
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
Outcome evaluators will be blinded to study condition. It is not possible to blind participants, the research staff enrolling the participant, or the treating clinicians.
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
- •Positive for suicide risk on the Patient Safety Screener in the ED (active suicidal ideation int the past 2 weeks, or suicidal attempt in the past 6 months)
- •Cognitively and emotionally capable of consent and engaging in Jaspr app.
- •Reads English at 6th grade level.
- •Reliable telephone access.
- •Owns a smart phone
- •Lives in Massachusetts
排除标准
- •Prisoners or in state custody
- •Adults unable to consent
- •Patient <18 yeas
- •Enrolled subjects during the 12 month follow-up period
研究组 & 干预措施
Enhanced treatment as usual (ETAU) alone
Subjects in this arm will receive the usual care for patients with suicidal risk at UMass Memorial ED that may include a behavioral health evaluation by a trained clinician, and environmental safety precautions dictated by risk level (Mild, Moderate, High). Individuals deemed appropriate for discharge undergo discharge planning and offered a personalized safety plan using the Stanley-Brown Safety Planning Intervention, including lethal means safety counseling.
干预措施: ETAU (Behavioral)
Jaspr intervention with enhanced treatment as usual (ETAU)
Subjects in this arm will receive ETAU in addition, they will complete a guided Suicide Status Interview (SSI), Safety Planning, and Lethal means counseling on the Jaspr tablet-based app before open access to the Jaspr resource library.
Subjects can sign up to receive JAH mobile app.
干预措施: Jaspr App + JAH (Device)
Jaspr intervention with enhanced treatment as usual (ETAU)
Subjects in this arm will receive ETAU in addition, they will complete a guided Suicide Status Interview (SSI), Safety Planning, and Lethal means counseling on the Jaspr tablet-based app before open access to the Jaspr resource library.
Subjects can sign up to receive JAH mobile app.
干预措施: ETAU (Behavioral)
结局指标
主要结局
Suicide composite, binary
时间窗: 12 months after enrollment
Death by suicide OR suicide-related acute care utilization within 12 months after enrollment
次要结局
- Suicidal behavior(12 months after enrollment)
- Suicidal ideation severity(12 months after enrollment)
- Suicidal attempt(12 months after enrollment)
研究者
Edwin Boudreaux
Professor
University of Massachusetts, Worcester