Premature Termination of Resuscitation in Survivors of Cardiac Arrest

NCT01472458 | Completed

• 1 other identifier: SPARC - PremaTOR
• Study Type: interventional
• Target: 905
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiac Arrest

Keywords

Cardiac arrest; Hypothermia; Post Cardiac Arrest Care; Survivors of cardiac arrest

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Qualitative Aim

  Two years

Study Arms (2)

Active Intervention

ACTIVE COMPARATOR

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

Control Hospitals

NO 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.

Interventions

Quality improvement BEHAVIORAL

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 Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who die within 6 hours of emergency department arrival

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Heart and Stroke Foundation of Canada: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Related Publications (1)

• 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.

  PMID: 27115286 DERIVED

MeSH Terms

Conditions

Heart Arrest; Hypothermia

Interventions

Quality Improvement

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Engineering; Technology, Industry, and Agriculture; Quality of Health Care; Health Services Administration

Study Officials

• Damon C Scales, MD PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: November 16, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 6, 2017

Record last verified: 2017-02