Acute AgitationNCT02512705
Medical Monitoring for Agitated Patients Pilot RCT - Medical Monitoring
A study testing Pinel Restraints and Seclusion Room in people with Acute Agitation, run by St. Joseph's Healthcare Hamilton.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Agitation
- What is being tested?
- Pinel Restraints and Seclusion Room
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Acute Agitation
- Being tested
- Pinel Restraints, Seclusion Room
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pinel RestraintsDevice
Seclusion RoomBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Seclusion Room | Other | The current practice is followed as a control group A. Receives: Behavioral: Seclusion Room |
| Physical Restraint | Experimental | Patient is placed in physical restraints to enable delivery of chemical restraints and medical monitoring and is monitored 1:1. Receives: Device: Pinel Restraints |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of feasibility, as measured by the recruitment rates
Process
Measured: 3 months
Analysis of feasibility, as measured by staff and resource availability
Resources
Measured: 3 months
Analysis of feasibility, as measured by baseline data of demographic and clinical characteristics
Scientific
Measured: 3 months
Secondary outcomes (3)
Occurrence of medical event
Were there any medical events? What was the time to the first medical event?
Measured: 3 months
Time to medical event response
What was the time taken to respond to a medical event from the start of the intervention?
Measured: 3 months
Time of agitation event response
What was the time it took to respond to an agitation event?
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janet Patterson, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512705
- Sponsor's protocol ID
- Patterson-1
- Status last verified
- Jul 2015
- First submitted
- 23 Jul 2015
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02512705
- Acronym / sponsor ID
- Patterson-1
- Conditions
- Acute Agitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 31 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seclusion Room | Other | Behavioral: Seclusion RoomThe current practice is followed as a control group A. |
| Physical Restraint | Experimental | Device: Pinel RestraintsPatient is placed in physical restraints to enable delivery of chemical restraints and medical monitoring and is monitored 1:1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pinel Restraints | Device | Physical Restraint |
| Seclusion Room | Behavioural | Seclusion Room |
Primary outcome
Analysis of feasibility, as measured by the recruitment rates
Time frame: 3 months
Process
Analysis of feasibility, as measured by staff and resource availability
Time frame: 3 months
Resources
Analysis of feasibility, as measured by baseline data of demographic and clinical characteristics
Time frame: 3 months
Scientific
3 secondary outcomes
Occurrence of medical event
Time frame: 3 months
Time to medical event response
Time frame: 3 months
Time of agitation event response
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Pinel Restraints and Seclusion Room in people with Acute Agitation, run by St. Joseph's Healthcare Hamilton.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hava Starkman, BScH (905-522-4941 ext. 33600, hava.starkman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of feasibility, as measured by the recruitment rates (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2015.