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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
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Agitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 23, 2015
    Last Updated
    July 29, 2015
    Sponsor
    St. Joseph's Healthcare Hamilton
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    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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