跳至主要内容
临床试验/NCT05825820
NCT05825820招募中不适用

Pilot Study Health System/Community Partnership for Enhanced Outreach to Prevent Suicide Attempts

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年7月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Self-Report Ratings of Intervention Acceptability

研究概览

简要总结

The goal of this clinical trial is to test an enhanced outreach intervention (EOI) delivered by Samaritans of Boston (a community organization that provides support during mental health crises) for people after they leave an emergency department (ED) visit for suicidal thoughts. The main questions the trial aims to answer are:

  • Is the EOI feasible and acceptable?
  • Can the EOI be delivered with fidelity by Samaritans staff?

Participants will:

  • Receive outreach (by call or text) once per week for 12 weeks after ED visit. During these conversations, Samaritans staff will ask participants questions about their suicidal thoughts and behaviors, develop and review a list of coping skills to use if they have suicidal thoughts, and discuss plans for receiving mental health care.
  • Receive caring messages from Samaritans staff at least once per week.
  • Be asked to complete monthly self-report questionnaires, and participate in a phone interview with study staff at the end of the study.

详细描述

The period after discharge from an emergency department (ED) is a critical time of increased risk for suicide and related behavior (SRB). Brief "caring contact" interventions that provide follow-up and support after a healthcare visit have been shown to reduce SRB and are now recommended best practices for suicide prevention in healthcare systems. However, system- and individual-level barriers to widespread implementation exist. For example, deployment of brief contact interventions requires dedicated resources and staffing within already overburdened healthcare settings, and even single-session interventions require robust provider training and ongoing oversight for successful implementation.

The purpose of this study is to evaluate a recently developed Enhanced Outreach Intervention (EOI) for post-ED discharge that combines multiple evidence-based suicide prevention components (e.g., safety planning, risk assessment, caring contacts, and care engagement) and is delivered through a partnership between a healthcare system (Mass General Brigham [MGB]) and a local crisis line organization (Samaritans of Boston). Combining multiple evidence-based interventions has the potential to increase effectiveness over usual practices, and partnering with a community organization vastly increases scalability.

Samaritans staff will undergo robust, multifaceted training on the EOI, and use standardized decision trees to guide EOI delivery. In this trial, the investigators will develop operational workflows for using a suicide risk algorithm to identify patients to receive the EOI, conduct a small open pilot of the EOI (N = 20), and assess the barriers and facilitators, and feasibility, acceptability, and fidelity of implementing the EOI in an academic medical setting to inform intervention refinement.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • Currently a patient being treated and evaluated by psychiatry service in an MGB ED
  • Participants enrolled in another study (NCT05671133; PI Nock) conducted by the research team who fall into the top 50% of risk based on the suicide risk prediction algorithm used in that study
  • Able to read English
  • Ownership of a smartphone (iOS or Android) and consistent access to their smartphone following discharge from the current treatment unit or program; ability to be reliably contacted
  • Willing to provide contact information for collateral contact
  • Willing to share contact information and key clinical information with Samaritans of Boston
  • Consent to unencrypted text or email communications
  • Willing to provide social security number (SSN) or individual taxpayer identification number (ITIN) for study compensation

排除标准

  • Any factor that impairs an individual's ability to comprehend and effectively participate in informed consent, including the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, or acute intoxication
  • Presence of extremely agitated or violent behavior at the time of consent or enrollment

研究组 & 干预措施

Enhanced Outreach Intervention plus Care as Usual

Experimental

Participants will receive the Enhanced Outreach Intervention (EOI) plus care as usual for 12 weeks after ED discharge.

干预措施: Enhanced Outreach Intervention (EOI) plus Care as Usual (Behavioral)

结局指标

主要结局

Self-Report Ratings of Intervention Acceptability

时间窗: Week 12 of the intervention

The acceptability of the EOI will be measured by the Acceptability of Intervention Measure (AIM). The scale values range from 1 to 5. Higher scores mean higher acceptability.

Self-Report Ratings of Intervention Feasibility

时间窗: Week 12 of the intervention

The feasibility of the EOI will be measured by the Feasibility of Intervention Measure (FIM). The scale values range from 1 to 5. Higher scores mean higher feasibility.

次要结局

  • Treatment Attendance(4 weeks, 8 weeks, and 12 weeks)
  • Intensity of Suicidal Ideation(Baseline, 4 weeks, 8 weeks, and 12 weeks)
  • Depressive Symptoms(Baseline, 4 weeks, 8 weeks, and 12 weeks)
  • Suicide Attempts(4 weeks, 8 weeks, and 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jordan W. Smoller, MD

Director, Center for Precision Psychiatry

Massachusetts General Hospital

研究点 (1)

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