Recruiting

Observational Study

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT02676024

Conditions

Cardiac Arrest

Cardiopulmonary Resuscitation

Simulation

Education

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Knowledge-based cognitive aid

Cognitive aids with roles defined (CARD)

Integrated cognitive aids

Study Details

Brief 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

Study ID

NCT02676024

Start date

Jul 5, 2017

Status verified date

Aug, 2017

Completion date

Dec, 2019

Anticipated

Primary completion date

Jul, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Team Leader: Resident in Pediatrics, Anesthesia, or Emergency Medicine training programs and College of Family Physicians of Canada resident. Fellows in Pediatric Emergency Medicine, Pediatric Critical Care or Pediatric Anesthesia sub-specialty training programs. Staff general Pediatricians.

Team members: Registered Nurses, Respiratory Therapists, Pediatric Residents.

Exclusion Criteria:

Decline to consent to participation. Those that would not attend a code outside of the operating room.

Study Design

Enrollment

456 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

Resuscitation teams will participate in a simulated pediatric cardiac arrest scenario, and provide standard CPR without being provided cognitive aids. Participants in this group will be allowed to use any cognitive aid that they happen to keep with them and would normally use in their practice, for example, flash cards or smart phone apps.

experimental: Knowledge-based cognitive aid

Resuscitation teams participate in a simulated pediatric cardiac arrest scenario, and provide standard CPR. However, they will be trained in using a knowledge-based cognitive aid, which will be used by a dedicated team member (the cognitive aid "reader").

experimental: Cognitive aids with roles defined (CARD)

Resuscitation teams participate in a simulated pediatric cardiac arrest scenario, and provide standard CPR. Participants will be trained to use the cognitive aids with roles defined (CARD) system. However, they will not be given knowledge-based cognitive aids and there will be no dedicated cognitive aid reader in the team.

experimental: Integrated cognitive aids

Participants will be trained to use the cognitive aids with roles defined (CARD) system and also in the use of a protocol-based cognitive aid, which will be used by a dedicated cognitive aid reader.

Interventions

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").

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").

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".

Primary outcome measure

  • Adherence to PALS guidelines as measured by the clinical performance tool (CPT) [ Time Frame: At baseline (pre-test) ]
  • Adherence to PALS guidelines as measured by the clinical performance tool (CPT) [ Time Frame: At post-test 1 (same day as pre-test) ]
  • Adherence to PALS guidelines as measured by the clinical performance tool (CPT) [ Time Frame: At post-test 2 (same day as pre-test) ]

Central Contacts and Locations

Locations

Children's Hospital of Eastern Ontario

Recruiting

Ottawa, Ontario, Canada, K1H 8L1

Contacts

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Aug 14, 2017

Last verified

Aug, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2017-08-14.