NCT00683683

Brief Summary

Background: One of the 2010 Impact Goals of the Emergency Cardiac Care (ECC) Committee of the American Heart Association is to double survival from cardiac arrest. Currently, approximately 60% of adults and 50% of paediatric patients that regain spontaneous circulation following cardiac arrest die before leaving the hospital. A key piece of the "chain of survival" is this fifth link; the care of patients post-arrest. Although there are several modalities recommended for post arrest care, therapeutic hypothermia is the only in-hospital therapy that has been demonstrated in randomized clinical trials to improve patient outcome after cardiac arrest. Despite the strong evidence for its efficacy and the apparent simplicity of this intervention, recent surveys show that hypothermia is delivered inconsistently, incompletely, and with undue delay in hospitals receiving resuscitated patients; only 26% of physicians and 26% of hospitals regularly institute a hypothermia protocol. Primary Objective: To design and apply a knowledge translation program for the 2005 AHA guideline on hypothermia post cardiac arrest and enable effective implementation of hypothermia in 100% of eligible OHCA patients. The integration of two robust data collection systems, which include both pre-hospital and in-hospital indicators, will give complete process of care and clinical outcome information for all cardiac arrest patients. Primary Endpoint: the proportion of eligible out of hospital cardiac arrest patients cooled to 32-34°C within 6 hours of ED arrival. Study Design: This project will be implemented through an established research collaborative of 43 hospitals in southern Ontario currently participating in the Toronto site of the Resuscitation Outcomes Consortium. A stepped wedge study design will be employed, whereby the intervention will be rolled-out sequentially to the participating hospitals over a number of time periods as sites reach pre-defined benchmarks. The multifaceted KT strategy will include 1) local multidisciplinary champions in ED, ICU, and Cardiology 2) A simple protocol for application of hypothermia, tailored to local needs and policy; 3) Identification of perceived and actual barriers to knowledge use; 4) Development of an implementation tool kit and 5) Providing timely feedback on benchmarks for hypothermia and outcomes

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2008

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2014

Enrollment Period

2.7 years

First QC Date

May 15, 2008

Last Update Submit

May 25, 2015

Conditions

Keywords

cardiac arrest, hypothermia, knowledge translation

Outcome Measures

Primary Outcomes (1)

  • The proportion of eligible out of hospital cardiac arrest patients cooled to 32-34°C within 6 hours of ED arrival.

    Within 6 hours of ED arrival.

Study Arms (1)

Cooling

OTHER

Cardiac arrest patients will be cooled to 32-34°C within 6 hours of ED arrival

Behavioral: Knowledge Translation

Interventions

The multifaceted KT strategy will include 1) local multidisciplinary champions in ED, ICU, and Cardiology 2) A simple protocol for application of hypothermia, tailored to local needs and policy; 3) Identification of perceived and actual barriers to knowledge use; 4) Development of an implementation tool kit and 5) Providing timely feedback on benchmarks for hypothermia and outcomes.

Also known as: Clinical Protocol;, Reminders;, Audit & Feedback;, Network
Cooling

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitals participating in the ROC network

You may not qualify if:

  • Hospitals who do not receive out-of-hospital cardiac arrest patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Morrison LJ, Brooks SC, Dainty KN, Dorian P, Needham DM, Ferguson ND, Rubenfeld GD, Slutsky AS, Wax RS, Zwarenstein M, Thorpe K, Zhan C, Scales DC; Strategies for Post-Arrest Care Network. Improving use of targeted temperature management after out-of-hospital cardiac arrest: a stepped wedge cluster randomized controlled trial. Crit Care Med. 2015 May;43(5):954-64. doi: 10.1097/CCM.0000000000000864.

  • Dainty KN, Scales DC, Brooks SC, Needham DM, Dorian P, Ferguson N, Rubenfeld G, Wax R, Zwarenstein M, Thorpe K, Morrison LJ. A knowledge translation collaborative to improve the use of therapeutic hypothermia in post-cardiac arrest patients: protocol for a stepped wedge randomized trial. Implement Sci. 2011 Jan 14;6:4. doi: 10.1186/1748-5908-6-4.

MeSH Terms

Conditions

Heart ArrestHypothermia

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Laurie Morrison, MD, MSc

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Rescu

Study Record Dates

First Submitted

May 15, 2008

First Posted

May 23, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

May 27, 2015

Record last verified: 2014-05