Consolidating Tools for Outcomes in Resuscitation (CONTOUR)
试验速览
- 阶段
- 不适用
- 入组人数
- 456
- 试验地点
- 4
- 主要终点
- Adherence to PALS guidelines as measured by the clinical performance tool (CPT)
研究概览
简要总结
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:
- To evaluate the effectiveness of knowledge-based cognitive aids, namely the Pediatric Advanced Life Support (PALS) algorithm cards, in healthcare teams.
- To evaluate the effectiveness of teamwork-based cognitive aids, namely the Cognitive Aids with Roles Defined (CARD) system, in healthcare teams.
- 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.
- 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.
详细描述
This study utilizes a prospective, randomized controlled, factorial study design, which examines the effect of integrating different elements of cognitive aids for training pediatric resuscitation team members. Recruited participants will be asked to perform as members of a multi-professional pediatric resuscitation team. The study uses simulation-based training as the primary method to evaluate the effect of both knowledge- and team-based cognitive aids on team performance, as measured by adherence to PALS guidelines. Participants will be teams of multi-professional pediatric resuscitation healthcare providers (physician, registered nurse, registered respiratory therapist). All participants will undertake a pre-test scenario, without access to either cognitive aid, regardless of group allocation. Participants will then be randomized to one of the four study arms using a list generated by an independent statistician. Randomization will be stratified by institution so that there are equal numbers of teams in each study arm in each participating institution of the multi-center study.
In study arm 1 (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. In study arm 2 (knowledge-aid), resuscitation teams will participate in the same scenario without using the CARD system but will be trained in the use of a knowledge-based cognitive aid, which will be used by a dedicated team member (the cognitive aid "reader"). In study arm 3 (CARD), participants will be trained to use the cognitive aids with roles defined (CARD) system but will not be given knowledge-based cognitive aids and there will be no dedicated cognitive aid reader in the team. In study arm 4 (integrated cognitive aid), participants will be trained to use the CARD system and also in the use of a protocol-based cognitive aid, which will be used by a dedicated cognitive aid reader.
All groups will then undertake a 20-minute e-learning module. E-learning modules will be developed to illustrate the principles of crisis resource management using text, images and short videos (of simulated scenarios) illustrating high- and low- performance in leadership, teamwork and task management. For the control group, the content will focus on team training principles and the PALS algorithm. For the knowledge-aid group, the content will also focus on team training principles and the PALS algorithm adding an introduction of the principle of using the knowledge-based cognitive aids provided with a cognitive aid "reader" designated by the team leader who will use a "do-verify" approach to the cognitive aid. For the CARD group, the content will also focus on team training principles and the PALS algorithm adding an introduction of the principles of the CARD system. For the integrated cognitive aid group, the content will focus on team training principles and the PALS algorithm adding an introduction of the principles of the CARD system and the principle of using the knowledge-based cognitive aids provided with a cognitive aid "reader" designated by the team leader who will use a "do-verify" approach to the cognitive aid.
All participants will then undergo a post-test scenario, with cognitive aids provided as per group allocation. A debriefing will follow in order to delineate the additional effect of simulation-based learning on the e-module. All study arms will then undertake a second-post-test scenario, with cognitive aids related to their group allocation followed by a second debriefing. Participants will be asked to complete a demographic questionnaire and a questionnaire on the use of cognitive aids.
In order to standardize scenarios between sites, the investigators will script the content of each scenario, including set transitions from one clinical state to another, programmed responses to expected interventions, and a pre-set duration. The scenarios will be piloted at the main study site and videos circulated to all other sites before piloting at those locations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Decline to consent to participation. Those that would not attend a code outside of the operating room.
研究组 & 干预措施
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.
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").
干预措施: Knowledge-based cognitive aid (Device)
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.
干预措施: Cognitive aids with roles defined (CARD) (Device)
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.
干预措施: Integrated cognitive aids (Device)
结局指标
主要结局
Adherence to PALS guidelines as measured by the clinical performance tool (CPT)
时间窗: At post-test 2 (same day as pre-test)
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
次要结局
- Frequency of use of the knowledge-based cognitive aid(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.)
- 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.)
- 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 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.)