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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Behavioral: Quality improvement

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 Type: Interventional
• Enrollment (Actual): 905
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: August 2, 2011
• First Submitted That Met QC Criteria: November 15, 2011
• First Posted (ESTIMATE): November 16, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 6, 2017
• Last Update Submitted That Met QC Criteria: February 3, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Cardiac arrest; Hypothermia; Post Cardiac Arrest Care; Survivors of cardiac arrest
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: SPARC - PremaTOR