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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02512705
Other study ID # Patterson-1
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 23, 2015
Last updated July 29, 2015
Start date September 2015
Est. completion date April 2016

Study information

Verified date July 2015
Source St. Joseph's Healthcare Hamilton
Contact Hava Starkman, BScH
Phone 905-522-4941
Email hava.starkman@gmail.com
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date April 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Device:
Pinel Restraints

Behavioral:
Seclusion Room


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
St. Joseph's Healthcare Hamilton

Outcome

Type Measure Description Time frame Safety issue
Primary Analysis of feasibility, as measured by the recruitment rates Process 3 months No
Primary Analysis of feasibility, as measured by staff and resource availability Resources 3 months No
Primary Analysis of feasibility, as measured by baseline data of demographic and clinical characteristics Scientific 3 months No
Secondary Occurrence of medical event Were there any medical events? What was the time to the first medical event? 3 months Yes
Secondary Time to medical event response What was the time taken to respond to a medical event from the start of the intervention? 3 months Yes
Secondary Time of agitation event response What was the time it took to respond to an agitation event? 3 months Yes
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