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Идёт набор NCT06223867

Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part A

Без фазы С лечением Suicidal Ideation Suicide Attempt Self Harm

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Jaspr App + JAH, ETAU.
Кому может быть актуально
Состояния в реестре: Suicidal Ideation, Suicide Attempt, Self Harm. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

  • Устройство Jaspr App + JAH
    With assistance form a research coordinator, the subject will complete self-administered suicide risk assessment on the tablet via Jaspr app, then the subject will engage with suicide-related coping skills and resources that the app provides. Subject will continue to have access to the coping skills and videos via a mobile app after discharge.
  • Поведенческое ETAU
    Usual care for suicidal patients at UMass Memorial ED that may include Behavioral health evaluation by a trained clinician. Environmental safety precautions. Personalized safety upon discharge

Первичные конечные точки

  • Suicide composite, binary [Срок оценки: 12 months after enrollment]
Вторичные конечные точки (3)
  • Suicidal attempt [Срок оценки: 12 months after enrollment]
  • Suicidal behavior [Срок оценки: 12 months after enrollment]
  • Suicidal ideation severity [Срок оценки: 12 months after enrollment]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • Prisoners or in state custody
  • Adults unable to consent
  • Patient <18 yeas
  • Enrolled subjects during the 12 month follow-up period

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • UMass Memorial Health — Worcester

Идентификаторы

NCT: NCT06223867 · STUDY00000716 Part A · 1P50MH129701

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗