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 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.
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 →St. Joseph's Healthcare Hamilton is the lead sponsor of 137 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
The current practice is followed as a control group A.
Behavioral: Seclusion Room
Patient is placed in physical restraints to enable delivery of chemical restraints and medical monitoring and is monitored 1:1.
Device: Pinel Restraints
Analysis of feasibility, as measured by the recruitment rates
Process
Time frame: 3 months
Analysis of feasibility, as measured by staff and resource availability
Resources
Time frame: 3 months
Analysis of feasibility, as measured by baseline data of demographic and clinical characteristics
Scientific
Time frame: 3 months
Occurrence of medical event
Were there any medical events? What was the time to the first medical event?
Time frame: 3 months
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
Time of agitation event response
What was the time it took to respond to an agitation event?
Time frame: 3 months
No study locations are listed for this record.
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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St. Joseph's Healthcare Hamilton