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Status unknownNCT02512705Updated Jul 31, 2015

Medical Monitoring for Agitated Patients Pilot RCT - Medical Monitoring

An interventional study of Pinel Restraints and Seclusion Room in Acute Agitation, sponsored by St. Joseph's Healthcare Hamilton. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-31.

Sponsored by St. Joseph's Healthcare Hamilton · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Acute Agitation

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03

In context

Psychomotor Agitation

500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.

This study's planned enrollment of 90 is close to the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.

Browse Psychomotor Agitation studies →

Lead sponsor

St. Joseph's Healthcare Hamilton is the lead sponsor of 137 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Other
    Seclusion Room

    The current practice is followed as a control group A.

    Behavioral: Seclusion Room

  • Experimental
    Physical Restraint

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

    Device: Pinel Restraints

Interventions

  • DevicePinel Restraints
  • BehavioralSeclusion Room
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What researchers measure

Primary outcomes

  1. Analysis of feasibility, as measured by the recruitment rates

    Process

    Time frame: 3 months

  2. Analysis of feasibility, as measured by staff and resource availability

    Resources

    Time frame: 3 months

  3. Analysis of feasibility, as measured by baseline data of demographic and clinical characteristics

    Scientific

    Time frame: 3 months

Secondary outcomes

  1. Occurrence of medical event

    Were there any medical events? What was the time to the first medical event?

    Time frame: 3 months

  2. Time to medical event response

    What was the time taken to respond to a medical event from the start of the intervention?

    Time frame: 3 months

  3. Time of agitation event response

    What was the time it took to respond to an agitation event?

    Time frame: 3 months

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02512705
Lead sponsor
St. Joseph's Healthcare Hamilton
Responsible party
Janet Patterson (Medical Lead Psychiatric Emergency Services, St. Joseph's Healthcare Hamilton) — Principal investigator
First posted
Jul 31, 2015
Start date
Sep 2015
Primary completion
Dec 2015 (estimated)
Completion
Apr 2016 (estimated)
Last update
Jul 31, 2015

Study contacts

Hava Starkman, BScH
Contact
hava.starkman@gmail.com
905-522-4941 ext. 33600

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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