Medical Monitoring for Agitated Patients Pilot RCT - Medical Monitoring

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Agitation
• Intervention / Treatment: Behavioral: Seclusion Room; Device: Pinel Restraints

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Seclusion Room; The current practice is followed as a control group A.	Behavioral: Seclusion Room
Experimental: Physical Restraint; Patient is placed in physical restraints to enable delivery of chemical restraints and medical monitoring and is monitored 1:1.	Device: Pinel Restraints

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of feasibility, as measured by the recruitment rates	Process	3 months
Analysis of feasibility, as measured by staff and resource availability	Resources	3 months
Analysis of feasibility, as measured by baseline data of demographic and clinical characteristics	Scientific	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of medical event	Were there any medical events? What was the time to the first medical event?	3 months
Time to medical event response	What was the time taken to respond to a medical event from the start of the intervention?	3 months
Time of agitation event response	What was the time it took to respond to an agitation event?	3 months

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: July 23, 2015
• First Submitted That Met QC Criteria: July 29, 2015
• First Posted (Estimate): July 31, 2015

Study Record Updates

• Last Update Posted (Estimate): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 29, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Psychomotor Agitation
• Other Study ID Numbers: Patterson-1