Consolidating Tools for Outcomes in Resuscitation

NCT02676024 | Unknown DMC

• 1 other identifier: 20150075-01H
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 2

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. 1.To evaluate the effectiveness of knowledge-based cognitive aids, namely the Pediatric Advanced Life Support (PALS) algorithm cards, in healthcare teams.
2. 2.To evaluate the effectiveness of teamwork-based cognitive aids, namely the Cognitive Aids with Roles Defined (CARD) system, in healthcare teams.
3. 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. 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.

Conditions

Cardiac Arrest; Cardiopulmonary Resuscitation; Simulation; Education

Outcome Measures

Primary Outcomes (3)

• Adherence to PALS guidelines as measured by the clinical performance tool (CPT)

  Simulated scenarios will be videotaped. These will be scored according to the CPT which is a task-specific checklist that is reliable and validated in assessing performance in a multi-professional team

  At baseline (pre-test)

• Adherence to PALS guidelines as measured by the clinical performance tool (CPT)

  Simulated scenarios will be videotaped. These will be scored according to the CPT which is a task-specific checklist that is reliable and validated in assessing performance in a multi-professional team

  At post-test 1 (same day as pre-test)

• Adherence to PALS guidelines as measured by the clinical performance tool (CPT)

  Simulated scenarios will be videotaped. These will be scored according to the CPT which is a task-specific checklist that is reliable and validated in assessing performance in a multi-professional team

  At post-test 2 (same day as pre-test)

Secondary Outcomes (6)

• Time to initiation of cardiopulmonary resuscitation

  This outcome measure will be assessed during the pre-test, post-test 1 and post-test 2. All the scenarios take place on the same day.

• Time to administration of epinephrine

  This outcome measure will be assessed during the pre-test, post-test 1 and post-test 2. All the scenarios take place on the same day.

• Time to defibrillation after the start of phase 2 of the scenario (VF)

  This outcome measure will be assessed during the pre-test, post-test 1 and post-test 2. All the scenarios take place on the same day.

• Percentage of "no-flow" time without chest compressions

  This outcome measure will be assessed during the pre-test, post-test 1 and post-test 2. All the scenarios take place on the same day.

• Team Emergency Assessment Measure (TEAM) scale

  This outcome measure will be assessed during the pre-test, post-test 1 and post-test 2. All the scenarios take place on the same day.

Study Arms (4)

Control

NO INTERVENTION

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.

Knowledge-based cognitive aid

EXPERIMENTAL

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").

Device: Knowledge-based cognitive aid

Cognitive aids with roles defined (CARD)

EXPERIMENTAL

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.

Device: Cognitive aids with roles defined (CARD)

Integrated cognitive aids

EXPERIMENTAL

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.

Device: Integrated cognitive aids

Interventions

Knowledge-based cognitive aid DEVICE

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").

Knowledge-based cognitive aid

Cognitive aids with roles defined (CARD) DEVICE

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").

Cognitive aids with roles defined (CARD)

Integrated cognitive aids DEVICE

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".

Integrated cognitive aids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Physicians' Services Incorporated Foundation: collaborator
• University of Ottawa: collaborator
• Children's Hospital of Eastern Ontario: collaborator
• The Hospital for Sick Children: collaborator
• Montreal Children's Hospital of the MUHC: collaborator
• Alberta Children's Hospital: collaborator
• Stollery Children's Hospital: collaborator

Study Sites (2)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: February 5, 2016
• Study Start: July 5, 2017
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 14, 2017

Record last verified: 2017-08

Locations

CA (2)