Clinical trial NCT02512705: Medical Monitoring for Agitated Patients Pilot RCT - Medical Monitoring
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Agitation
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2015-07-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Analysis of feasibility, as measured by the recruitment rates
timeFrame: 3 months
measure: Analysis of feasibility, as measured by staff and resource availability
timeFrame: 3 months
measure: Analysis of feasibility, as measured by baseline data of demographic and clinical characteristics
timeFrame: 3 months
Secondary outcomes:
measure: Occurrence of medical event
timeFrame: 3 months
measure: Time to medical event response
timeFrame: 3 months
measure: Time of agitation event response
timeFrame: 3 months
Other outcomes:
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Study officials:
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