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Premature Termination of Resuscitation in Survivors of Cardiac Arrest (PremaTOR)

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Quality improvement
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiac Arrest focused on measuring Cardiac arrest, Hypothermia, Post Cardiac Arrest Care, Survivors of cardiac arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients =/> 18 years of age
  • Non-traumatic out of hospital cardiac arrest
  • Sustained return of spontaneous circulation (palpable pulse for > 20 minutes)
  • Comatose (i.e. without full neurological recovery; non-responsive to verbal commands)
  • Surviving to at least 6 hours after emergency department arrival

Exclusion Criteria:

  • Patients who die within 6 hours of emergency department arrival

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Active Intervention

    Control Hospitals

    Arm Description

    This stepped-wedge cluster randomized evaluation will randomly allocate 18 hospitals into 4 groups to receive our active intervention at different sequential time points according to the randomly assigned stepped-wedge schedule. Hospitals will function as control hospitals until it is their turn to receive the active intervention, according to the stepped wedge schedule. Each wedge consists of 4-5 hospitals and will last 5 months.

    This stepped-wedge cluster randomized evaluation will randomly allocate 18 hospitals into 4 groups to receive our active intervention at different sequential time points according to the randomly assigned stepped-wedge schedule. Hospitals will function as control hospitals until it is their turn to receive the active intervention, according to the stepped wedge schedule. Each wedge consists of 4-5 hospitals and will last 5 months.

    Outcomes

    Primary Outcome Measures

    Effective knowledge strategy
    Our primary endpoint measures the uptake of appropriate neurological prognostication in survivors of cardiac arrest. We define appropriate neurological prognostication as the number of patients that have appropriate prognostic testing (as recommended by Advanced Life Support/ILCOR guidelines) performed before death but occurring at least 72 hours after the cardiac arrest; the denominator for this endpoint is the total number of patients admitted to hospital following cardiac arrest excluding deaths unrelated to predictions of poor neurological prognosis.

    Secondary Outcome Measures

    Qualitative Aim
    To understand reasons for premature termination of life sustaining therapy and barriers to evidence based neurological prognostication in survivors of cardiac arrest.

    Full Information

    First Posted
    August 2, 2011
    Last Updated
    February 3, 2017
    Sponsor
    Sunnybrook Health Sciences Centre
    Collaborators
    Heart and Stroke Foundation of Canada, Canadian Institutes of Health Research (CIHR)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01472458
    Brief Title
    Premature Termination of Resuscitation in Survivors of Cardiac Arrest
    Acronym
    PremaTOR
    Official Title
    Premature Termination of Resuscitation in Survivors of Cardiac Arrest
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2011 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sunnybrook Health Sciences Centre
    Collaborators
    Heart and Stroke Foundation of Canada, Canadian Institutes of Health Research (CIHR)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study Premature Termination of Resuscitation in Survivors of Cardiac Arrest focuses on using innovative knowledge translation strategies to improve appropriate neuroprognostication for survivors of cardiac arrest and prevent premature termination of life sustaining therapies. This is important because any early gains achieved during resuscitation will be nullified if clinicians terminate life-sustaining therapies prematurely based on inadequate prognostic information. An effective translation strategy for neuroprognostication will result in improved physician adherence to evidence-based medicine and an increase in the proportion of patients surviving to achieve a good neurological outcome following cardiac arrest.
    Detailed Description
    A stepped wedge cluster randomized trial design will be employed in order to properly evaluate the impact of this intervention. Each of the 18 participating hospitals will be randomized one of the four wedges according to a random schedule; each wedge will consist of 4 to 5 hospitals. With this design, the implementation of the intervention will be rolled out sequentially to the participating hospitals over a 5 month period for each wedge. All hospitals will have received the intervention by the end of the study. Note that the study design fields provided by ClinicalTrials.gov do not allow for describing this type of study design; therefore, the investigators have listed the study as a single arm. In reality, this study will have 4 wedges, each containing randomized clusters of 4-5 hospitals.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Arrest
    Keywords
    Cardiac arrest, Hypothermia, Post Cardiac Arrest Care, Survivors of cardiac arrest

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    905 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active Intervention
    Arm Type
    Active Comparator
    Arm Description
    This stepped-wedge cluster randomized evaluation will randomly allocate 18 hospitals into 4 groups to receive our active intervention at different sequential time points according to the randomly assigned stepped-wedge schedule. Hospitals will function as control hospitals until it is their turn to receive the active intervention, according to the stepped wedge schedule. Each wedge consists of 4-5 hospitals and will last 5 months.
    Arm Title
    Control Hospitals
    Arm Type
    No Intervention
    Arm Description
    This stepped-wedge cluster randomized evaluation will randomly allocate 18 hospitals into 4 groups to receive our active intervention at different sequential time points according to the randomly assigned stepped-wedge schedule. Hospitals will function as control hospitals until it is their turn to receive the active intervention, according to the stepped wedge schedule. Each wedge consists of 4-5 hospitals and will last 5 months.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Quality improvement
    Intervention Description
    The primary intervention in this project will be a multi-faceted quality improvement plan targeting improved predictions of neurological outcome and survival after cardiac arrest.
    Primary Outcome Measure Information:
    Title
    Effective knowledge strategy
    Description
    Our primary endpoint measures the uptake of appropriate neurological prognostication in survivors of cardiac arrest. We define appropriate neurological prognostication as the number of patients that have appropriate prognostic testing (as recommended by Advanced Life Support/ILCOR guidelines) performed before death but occurring at least 72 hours after the cardiac arrest; the denominator for this endpoint is the total number of patients admitted to hospital following cardiac arrest excluding deaths unrelated to predictions of poor neurological prognosis.
    Time Frame
    Two years
    Secondary Outcome Measure Information:
    Title
    Qualitative Aim
    Description
    To understand reasons for premature termination of life sustaining therapy and barriers to evidence based neurological prognostication in survivors of cardiac arrest.
    Time Frame
    Two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients =/> 18 years of age Non-traumatic out of hospital cardiac arrest Sustained return of spontaneous circulation (palpable pulse for > 20 minutes) Comatose (i.e. without full neurological recovery; non-responsive to verbal commands) Surviving to at least 6 hours after emergency department arrival Exclusion Criteria: Patients who die within 6 hours of emergency department arrival
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Damon C Scales, MD PhD
    Organizational Affiliation
    Sunnybrook Health Sciences Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27115286
    Citation
    Scales DC, Golan E, Pinto R, Brooks SC, Chapman M, Dale CM, Jichici D, Rubenfeld GD, Morrison LJ; Strategies for Post-Arrest Resuscitation Care Network. Improving Appropriate Neurologic Prognostication after Cardiac Arrest. A Stepped Wedge Cluster Randomized Controlled Trial. Am J Respir Crit Care Med. 2016 Nov 1;194(9):1083-1091. doi: 10.1164/rccm.201602-0397OC.
    Results Reference
    derived

    Learn more about this trial

    Premature Termination of Resuscitation in Survivors of Cardiac Arrest

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