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临床试验/NCT01150994
NCT01150994已完成不适用

Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)

University of Massachusetts, Worcester8 个研究点 分布在 1 个国家目标入组 1,440 人开始时间: 2010年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,440
试验地点
8
主要终点
Percentage of ER patients screened for self harm

研究概览

简要总结

The NIMH s RFA-Suicide Prevention in Emergency Medicine Departments recognizes the emergency department (ED) as an important setting to increase suicide detection and prevention efforts but observes that evidence-based practice guidelines do not exist. In response, we have designed the Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) trial. The ED-SAFE study will be conducted using a quasi-experimental design appropriate for studying systems-based change. The study consists of two components (Screening Outcome & Intervention Evaluation) and three phases of data collection: Treatment as Usual, Screening Alone, and Intervention. During each phase, 480 suicidal patients (1,440 total) will be enrolled and followed using multiple methods for 12 months.

The Screening Outcome Component

The Screening Outcome component will use data collected during the Treatment as Usual and Screening Alone phases. Consistent with systems-change principles, when universal screening is incorporated during the Screening Alone phase, it will be completed by the primary nurse as part of routine care. Primarily, it will focus on testing a practical approach to screen ED patients for suicidal ideation and behavior and will assess its impact on suicide detection, process outcomes, and suicide behaviors.

Intervention Evaluation Component

The Intervention Evaluation component will use data from the Treatment as Usual, Screening Alone, and Intervention Phases. During the Intervention phase, each ED will implement a multi-component, systems-based Intervention called the Safety Assessment and Follow-up Telephone Intervention (SAFTI). The SAFTI will combine elements of: (a) safety planning administered by nursing staff in the ED, and (b) Coping Long Term with Active Suicide Program (CLASP)-ED, a series of up to 7 semi-structured telephone advising calls to the patient and 4 to the significant other over the 12 months after the ED visit. Safety planning will be implemented universally to all suicidal patients, regardless of whether they are ultimately enrolled into the trial, as part of a comprehensive suicide management protocol (e.g., it is a systems-based change). However, for practical and budgetary considerations, the CLASP-ED telephone advising calls will be administered only to participants enrolled into the study.

Our overarching hypotheses will be tested using a combination of the Screening Outcome component and the Intervention Evaluation Component. We predict that screening will improve detection of suicidal ideation, and the intervention will enhance the quality of care and reduce suicide outcomes.

详细描述

see summary above

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Screening
盲法
Single (Participant)

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

  • •Entering care at a hospital ED,
  • •Documented thoughts or behaviors related to self-harm.

排除标准

  • •No phone or permanent address,
  • •Does not speak English or Spanish.

研究组 & 干预措施

Treatment as Usual

No Intervention

Screening Alone

No Intervention

Enhanced screening among ED patients

Safety Assessment and Follow-up Telephone Intervention

Experimental

SAFTI: Safety Assessment in the ED combine with a Follow-up Telephone Intervention.

干预措施: Safety Assessment and Follow-up Telephone Intervention (SAFTI). (Behavioral)

结局指标

主要结局

Percentage of ER patients screened for self harm

时间窗: July 2010 - November 2013

Suicide-related outcomes

时间窗: July 2010 - November 2014

* Preparatory acts * Suicide attempts * Completed suicides

Quality of care

时间窗: July 2010 - November 2014

* Process outcomes (e.g. receipt of safety plan) * Involvement in behavioral health treatment

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

Study Principal Investigator

University of Massachusetts, Worcester

研究点 (8)

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