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
  Purpose

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.


Condition Intervention
Cardiac Arrest
Behavioral: Quality improvement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Premature Termination of Resuscitation in Survivors of Cardiac Arrest

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 560
Study Start Date: October 2011
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472458

Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Heart and Stroke Foundation of Canada
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Damon C Scales, MD PhD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr. Damon Scales, Scientist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01472458     History of Changes
Other Study ID Numbers: SPARC - PremaTOR
Study First Received: August 2, 2011
Last Updated: January 16, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Cardiac arrest
Hypothermia
Post Cardiac Arrest Care
Survivors of cardiac arrest

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014