跳至主要内容
临床试验/NCT02512705
NCT02512705Unknown不适用

A Pilot Randomized Control Trial: The Ability to Medically Monitor With Use of Physical and Chemical Restraints or Seclusion of Acutely Agitated or Violent Patients Who Present to the Psychiatric Emergency Services

St. Joseph's Healthcare Hamilton0 个研究点目标入组 90 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
主要终点
Analysis of feasibility, as measured by the recruitment rates

研究概览

简要总结

The Psychiatric Emergency Services (PES) is an under researched area of clinical practice, largely in the management of acutely agitated and violent patients. The goal of this pilot randomized clinical trial (RCT) is to assess the benefit of medically monitoring patients that present with extreme agitation and/or violent behaviour to PES. Placing them in physical restraints and immediately administering chemical restraint, will enable medical monitoring of these potentially medically unstable patients. Investigators believe that this practice will provide safer management of patients, reduce risk to staff and other patients, reduce risk of undiagnosed medical conditions that underly the agitation, and increase clinical management and quality of care. Patients that come into the Emergency Department that are agitated and violent, where verbal-deescalation will not suffice, will be randomly treated with either immediate placement in seclusion (current practice) or be placed in physical restraints and given chemical restraint (as outlined in the BETA project guidelines). The same time interval assessments will be performed on both groups of patients including; medical monitoring and agitation scale assessment. Data will also be collected on number of violent episodes, code whites, required increase in the use of physical restraints, length of intervention, and more. This assessment will enable a comparison between the current practice and the proposed practice to establish evidence based clinical guidelines for the management of acute agitation in PES, where de-escalation techniques are ineffective and the lack of medical monitoring is harmful to the patient and can negatively effect their outcome. In order to best assess the importance of medical monitoring for such patients, a pilot study must be performed to assess the feasibility of such a phase III RCT study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • Was agitated or violent upon entry into PES.
  • Is 18+ years of age.
  • Verbal de-escalation techniques are not useful for management of this patient.
  • BETA Project techniques alone are not useful for management of this patient.
  • The patient is assigned a CTAS1 or CTAS2 score.

排除标准

  • The patient scores a "Low" or "Moderate" level of risk on the Violence/Aggression Screening Tool (VAST) that is used at ER triage.
  • The point of agitation or violence began after the patient was already admitted to PES.

结局指标

主要结局

Analysis of feasibility, as measured by the recruitment rates

时间窗: 3 months

Process

Analysis of feasibility, as measured by staff and resource availability

时间窗: 3 months

Resources

Analysis of feasibility, as measured by baseline data of demographic and clinical characteristics

时间窗: 3 months

Scientific

次要结局

  • Occurrence of medical event(3 months)
  • Time to medical event response(3 months)
  • Time of agitation event response(3 months)

研究者

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

Janet Patterson

Medical Lead Psychiatric Emergency Services

St. Joseph's Healthcare Hamilton

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