Premature Termination of Resuscitation in Survivors of Cardiac Arrest

Not Applicable

Completed

• Conditions: Cardiac Arrest
• Interventions: Behavioral: Quality improvement

• Registration Number: NCT01472458
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Study Timeline

• Study First Submitted: 2011-08-02
• Study Start: 2011-11
• Study First Submitted QC: 2011-11-15
• Study First Posted: 2011-11-16
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 905

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Intervention	Quality improvement	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.

Primary Outcome Measures

Name	Time	Method
Effective knowledge strategy	Two years	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

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