Medical Monitoring for Agitated Patients Pilot RCT - Medical Monitoring

NCT02512705 | Unknown DMC

• 1 other identifier: Patterson-1
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Agitation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Occurrence of medical event

  3 months

• Time to medical event response

  3 months

• Time of agitation event response

  3 months

Study Arms (2)

Seclusion Room

OTHER

The current practice is followed as a control group A.

Behavioral: Seclusion Room

Physical Restraint

EXPERIMENTAL

Patient is placed in physical restraints to enable delivery of chemical restraints and medical monitoring and is monitored 1:1.

Device: Pinel Restraints

Interventions

Pinel Restraints DEVICE

Physical Restraint

Seclusion Room BEHAVIORAL

Seclusion Room

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Central Study Contacts

Hava Starkman, BScH

CONTACT

905-522-4941; hava.starkman@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Lead Psychiatric Emergency Services

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: July 31, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: July 31, 2015

Record last verified: 2015-07