Medical Monitoring for Agitated Patients Pilot RCT - Medical Monitoring
Primary Purpose
Acute Agitation
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pinel Restraints
Seclusion Room
Sponsored by
About this trial
This is an interventional prevention trial for Acute Agitation
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Seclusion Room
Physical Restraint
Arm Description
The current practice is followed as a control group A.
Patient is placed in physical restraints to enable delivery of chemical restraints and medical monitoring and is monitored 1:1.
Outcomes
Primary Outcome Measures
Analysis of feasibility, as measured by the recruitment rates
Process
Analysis of feasibility, as measured by staff and resource availability
Resources
Analysis of feasibility, as measured by baseline data of demographic and clinical characteristics
Scientific
Secondary Outcome Measures
Occurrence of medical event
Were there any medical events? What was the time to the first medical event?
Time to medical event response
What was the time taken to respond to a medical event from the start of the intervention?
Time of agitation event response
What was the time it took to respond to an agitation event?
Full Information
NCT ID
NCT02512705
First Posted
July 23, 2015
Last Updated
July 29, 2015
Sponsor
St. Joseph's Healthcare Hamilton
1. Study Identification
Unique Protocol Identification Number
NCT02512705
Brief Title
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
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
April 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Agitation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Seclusion Room
Arm Type
Other
Arm Description
The current practice is followed as a control group A.
Arm Title
Physical Restraint
Arm Type
Experimental
Arm Description
Patient is placed in physical restraints to enable delivery of chemical restraints and medical monitoring and is monitored 1:1.
Intervention Type
Device
Intervention Name(s)
Pinel Restraints
Intervention Type
Behavioral
Intervention Name(s)
Seclusion Room
Primary Outcome Measure Information:
Title
Analysis of feasibility, as measured by the recruitment rates
Description
Process
Time Frame
3 months
Title
Analysis of feasibility, as measured by staff and resource availability
Description
Resources
Time Frame
3 months
Title
Analysis of feasibility, as measured by baseline data of demographic and clinical characteristics
Description
Scientific
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Occurrence of medical event
Description
Were there any medical events? What was the time to the first medical event?
Time Frame
3 months
Title
Time to medical event response
Description
What was the time taken to respond to a medical event from the start of the intervention?
Time Frame
3 months
Title
Time of agitation event response
Description
What was the time it took to respond to an agitation event?
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hava Starkman, BScH
Phone
905-522-4941
Ext
33600
Email
hava.starkman@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Medical Monitoring for Agitated Patients Pilot RCT - Medical Monitoring
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