Premature Termination of Resuscitation in Survivors of Cardiac Arrest

Study Overview
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Brief Summary
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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
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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.

Official Title
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Premature Termination of Resuscitation in Survivors of Cardiac Arrest

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Behavioral: Quality improvement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Intervention<br>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<br>* 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.<br>|
| No Intervention: Control Hospitals<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative Aim | To understand reasons for premature termination of life sustaining therapy and barriers to evidence based neurological prognostication in survivors of cardiac arrest. | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac arrest, Hypothermia, Post Cardiac Arrest Care, Survivors of cardiac arrest