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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Heart and Stroke Foundation of Canada
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Damon Scales, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01472458
First received: August 2, 2011
Last updated: January 16, 2013
Last verified: January 2013
History of Changes

August 2, 2011
January 16, 2013
October 2011
October 2013   (final data collection date for primary outcome measure)
Effective knowledge strategy [ Time Frame: Two years ] [ Designated as safety issue: No ]
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 deaths among patients admitted to hospital following cardiac arrest excluding deaths due to non-neurological causes.
Same as current
Complete list of historical versions of study NCT01472458 on ClinicalTrials.gov Archive Site
Qualitative Aim [ Time Frame: Two years ] [ Designated as safety issue: No ]
To understand reasons for premature termination of life sustaining therapy and barriers to evidence based neurological prognostication in survivors of cardiac arrest.
Same as current
Not Provided
Not Provided
 
Premature Termination of Resuscitation in Survivors of Cardiac Arrest
Premature Termination of Resuscitation in Survivors of Cardiac Arrest

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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Cardiac Arrest
Behavioral: Quality improvement
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.
  • Active Comparator: Active Intervention
    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: Behavioral: Quality improvement
  • No Intervention: Control Hospitals
    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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
560
Not Provided
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01472458
SPARC - PremaTOR
No
Dr. Damon Scales, Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
  • Heart and Stroke Foundation of Canada
  • Canadian Institutes of Health Research (CIHR)
Principal Investigator: Damon C Scales, MD PhD Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP