Medical Monitoring for Agitated Patients Pilot RCT - Medical Monitoring

Acute Agitation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02512705
• Other study ID #: Patterson-1
• Status: Not yet recruiting
• Phase: N/A
• First received: July 23, 2015
• Last updated: July 29, 2015
• Start date: September 2015
• Est. completion date: April 2016

Study information

• Verified date: July 2015
• Source: St. Joseph's Healthcare Hamilton
• Contact: Hava Starkman, BScH
• Phone: 905-522-4941
• Email: hava.starkman[@]gmail.com
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Agitation

Intervention

Device:
• Pinel Restraints

Behavioral:
• Seclusion Room

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of feasibility, as measured by the recruitment rates	Process	3 months	No
Primary	Analysis of feasibility, as measured by staff and resource availability	Resources	3 months	No
Primary	Analysis of feasibility, as measured by baseline data of demographic and clinical characteristics	Scientific	3 months	No
Secondary	Occurrence of medical event	Were there any medical events? What was the time to the first medical event?	3 months	Yes
Secondary	Time to medical event response	What was the time taken to respond to a medical event from the start of the intervention?	3 months	Yes
Secondary	Time of agitation event response	What was the time it took to respond to an agitation event?	3 months	Yes