Consolidating Tools for Outcomes in Resuscitation

NCT02676024 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2017-08-14

No results posted yet for this study

Summary

In-hospital pediatric cardiac arrest is an important public health problem affecting almost 6000 children a year in the United States. As many as 3% of patients admitted to a children's hospital require cardiopulmonary resuscitation (CPR). Only a minority of children survive, of which around 35% go on to have a poor neurological outcome. International consensus guidelines on science and treatment recommendations for the management of pediatric resuscitation have existed for decades and are revised periodically by the International Liaison Committee on Resuscitation (ILCOR) based on available evidence. This consensus is then used by national councils such as the American Heart Association (AHA) and the Heart and Stroke Foundation of Canada (HSFC) to make guidelines for care. These guidelines focus on a structured approach to resuscitation, which emphasizes the rapid implementation of key interventions such as starting chest compressions, administering epinephrine and defibrillation. The goal of this study is to improve outcomes after cardiac arrest in children by improving adherence to consensus guidelines. The investigators aim to achieve this by conducting a multi-center, prospective, factorial randomized study with participating sites from the International Network for Simulation-based Pediatric Innovation, Research and Education (INSPIRE).

The specific aims of this study are to:

1. To evaluate the effectiveness of knowledge-based cognitive aids, namely the Pediatric Advanced Life Support (PALS) algorithm cards, in healthcare teams.
2. To evaluate the effectiveness of teamwork-based cognitive aids, namely the Cognitive Aids with Roles Defined (CARD) system, in healthcare teams.
3. To determine if there is a synergistic effect when adding the CARD system to the use of knowledge-based cognitive aids or indeed whether using both these tools together has unintended consequences and reduces the added value of each technique.
4. To identify whether additional simulation-based team training in the use of cognitive aids results in a significant improvement in performance over an e-learning module.

The investigators hypothesize that (i) knowledge-based cognitive aids will significantly improve the performance of healthcare teams in providing PALS in a simulated setting, (ii) that teamwork-based cognitive aids (CARD) will significantly improve the performance of healthcare teams in providing PALS in a simulated setting, and that (iii) adding the CARD system to knowledge-based aids will have an added and synergistic effect, (iv) that the team performance in all study arms will improve after simulation based training, but that the groups with cognitive aids will continue to out-perform the groups without cognitive aids.

Conditions

  • Cardiac Arrest
  • Cardiopulmonary Resuscitation
  • Simulation
  • Education

Interventions

DEVICE

Knowledge-based cognitive aid

Trained on the use of a knowledge-based cognitive aid for pediatric cardiac arrests. Will be used by a dedicated team member (cognitive aid "reader").

DEVICE

Cognitive aids with roles defined (CARD)

Trained on the use of the cognitive aids with roles defined (CARD) system for pediatric cardiac arrests. Participants are given large identification cards to be worn, which enable the code leader to quickly recognize the individuals' purpose at the code. The card identifies specific tasks associated with the role, ensuring that the participant knows exactly what their task is. Will not have a dedicated team member during the scenario (cognitive aid "reader").

DEVICE

Integrated cognitive aids

Trained on the use of the cognitive aids with roles defined (CARD) system and also in the use of a protocol-based cognitive aid for pediatric cardiac arrests which will be used by a dedicated cognitive aid "reader".

Sponsors & Collaborators

  • The Physicians' Services Incorporated Foundation

    collaborator OTHER
  • University of Ottawa

    collaborator OTHER
  • Children's Hospital of Eastern Ontario

    collaborator OTHER
  • The Hospital for Sick Children

    collaborator OTHER
  • Montreal Children's Hospital of the MUHC

    collaborator OTHER
  • Alberta Children's Hospital

    collaborator OTHER
  • Stollery Children's Hospital

    collaborator OTHER
  • Ottawa Hospital Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-05
Primary Completion
2019-07-31
Completion
2019-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02676024 on ClinicalTrials.gov