Medical Monitoring for Agitated Patients Pilot RCT - Medical Monitoring

NCT ID: NCT02512705

Last Updated: 2015-07-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Seclusion Room

The current practice is followed as a control group A.

Group Type: OTHER

Seclusion Room

Intervention Type: BEHAVIORAL

Physical Restraint

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

Group Type: EXPERIMENTAL

Pinel Restraints

Intervention Type: DEVICE

Interventions

Pinel Restraints

Intervention Type: DEVICE

Seclusion Room

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

Janet Patterson

Medical Lead Psychiatric Emergency Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hava Starkman, BScH

Role: CONTACT

Phone: 905-522-4941

Email: hava.starkman@gmail.com

Other Identifiers

Patterson-1

Identifier Type: -

Identifier Source: org_study_id