- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02512705
Medical Monitoring for Agitated Patients Pilot RCT - Medical Monitoring
29. juli 2015 opdateret af: Janet Patterson, St. Joseph's Healthcare Hamilton
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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
90
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Seclusion Room
The current practice is followed as a control group A.
|
|
|
Eksperimentel: Physical Restraint
Patient is placed in physical restraints to enable delivery of chemical restraints and medical monitoring and is monitored 1:1.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Analysis of feasibility, as measured by the recruitment rates
Tidsramme: 3 months
|
Process
|
3 months
|
|
Analysis of feasibility, as measured by staff and resource availability
Tidsramme: 3 months
|
Resources
|
3 months
|
|
Analysis of feasibility, as measured by baseline data of demographic and clinical characteristics
Tidsramme: 3 months
|
Scientific
|
3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Occurrence of medical event
Tidsramme: 3 months
|
Were there any medical events?
What was the time to the first medical event?
|
3 months
|
|
Time to medical event response
Tidsramme: 3 months
|
What was the time taken to respond to a medical event from the start of the intervention?
|
3 months
|
|
Time of agitation event response
Tidsramme: 3 months
|
What was the time it took to respond to an agitation event?
|
3 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2015
Primær færdiggørelse (Forventet)
1. december 2015
Studieafslutning (Forventet)
1. april 2016
Datoer for studieregistrering
Først indsendt
23. juli 2015
Først indsendt, der opfyldte QC-kriterier
29. juli 2015
Først opslået (Skøn)
31. juli 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
31. juli 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juli 2015
Sidst verificeret
1. juli 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Patterson-1
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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