Effectiveness of an Interactive Cognitive Support Tablet App to Improve the Management of Pediatric Cardiac Arrest — PediAppRREST  

Cardiac Arrest Clinical Trial

Official title: PediAppRREST - Effectiveness of an Interactive Cognitive Support Tablet App in Reducing Deviations From Guidelines in the Management of Pediatric Cardiac Arrest: a Simulation-based Randomized Controlled Trial

Status Completed

Clinical Trial Summary

Pediatric cardiac arrest (PCA) has a high mortality and morbidity. Its management is complex and often deviates from guideline recommendations leading to patients' worse clinical outcomes. A new tablet app, named PediAppRREST has been developed by our research group to support the management of PCA. The aim of the study is to evaluate the impact of the PediAppRREST app on the management of a PCA simulated scenario. The investigators have planned to conduct a multicenter, simulation-based, randomized control trial assessing the number of deviations (errors and delays) from international recommendations in PCA management. The hypothesis is that teams who use the PediAppRREST app as a cognitive aid will show fewer deviations from guidelines than teams who use a static paper-based cognitive aid (American Heart Association Pediatric Advanced Life Support pocket reference card) or no cognitive aid, during the management of a simulated PCA scenario.

Clinical Trial Description

AIMS

The primary aim of the study is to evaluate the effectiveness of a new tablet app, named PediAppRREST, in reducing deviations from guideline recommendations during pediatric cardiac arrest management.

The secondary aim is to assess the impact of the use of the app on performance and time to accomplish critical interventions for resuscitation, team leader's workload, cardiopulmonary resuscitation quality metrics and overall resuscitation team performance. Furthermore, the study will have the purpose to evaluate the usability of the app.

METHODS

PARTICIPANTS

Participants will be residents in Pediatrics, Emergency Medicine, and Anesthesiology-Intensive Care programs at four Italian University Hospitals (Padova, Firenze, Novara, and Roma). In order to be included in the study, residents must be BLS (Basic Life Support) or P-BLS (Pediatric-Basic Life Support) or PALS (Pediatric Advanced Life Support) or ALS (Advanced Life Support) or ACLS (Advanced Cardiac Life Support) certified, following the American Heart Association (AHA) or the European Resuscitation Council (ERC) recommendations. Additionally, to be eligible for the role of team leader residents must be PALS-certified according to AHA or ERC guidelines. Those residents who are unable to attend the simulation sessions because of maternity/paternity leave, personal/sick leave or training abroad, or who have participated in previous studies using the PediAppRREST app will not be eligible to participate in the trial.

STUDY DESIGN

This will be a multicenter, randomized controlled, three-parallel arm study, conducted in the setting of simulation. All teams, each consisting of three participants, will manage the same scenario of non-shockable pediatric cardiac arrest with the help of one confederate nurse who will act according to a script. Participants will be randomized to teams, and teams to interventions, using a 1:1:1 ratio. According to the allocation into one of three study arms, teams will use, or not use, a different PALS-related cognitive aid during the management of the scenario: 1) an intervention group using the tablet app PediAppRREST; or 2) a control group (CtrlPALS+) using the AHA-PALS pocket reference card; or 3) a control group (CtrlPALS-) not allowed to use any cognitive aid.

All the simulation scenarios will be video recorded, and two independent, previously trained reviewers will report actions performed by the teams and time to accomplish them. Outcomes will be subsequently assessed by two independent outcome assessors using data extracted by video reviewers.

OUTCOMES

The primary outcome of the study will be the number of deviations from AHA PALS guidelines recommendations during the management of pediatric cardiac arrest, defined as delays and errors according to a novel checklist, named c-DEV15plus, based on previously published guidelines, checklists and scoring systems/evaluation tools.

The secondary outcomes will be the performance of critical actions for resuscitation and the time to perform them, the usability of the app (measured by open-ended questions and one validated questionnaire: the System Usability Scale), the team leaders' workload (measured by the validated NASA-Task Load Index), the quality metrics of cardiopulmonary resuscitation (extracted by the manikin's software SkillReporter, Laerdal™) according to AHA guidelines, and the overall team resuscitation performance (measured by the validated Clinical Performance Tool).

SAMPLE SIZE CALCULATION

The investigators calculated the sample size on the basis of the results obtained during two previous studies: one observational simulation-based study and one pilot study conducted to test the app usability. Based on the preliminary results from these studies, using a single factor ANOVA model, 29 scenarios per each of the three groups (PediAppRREST, CtrlPALS+, CtrlPALS-) are necessary to detect a difference of at least 3.00 points on the c-DEV15plus scale using the Tukey-Kramer (Pairwise) multiple comparison procedure at a 5% significance level and 80% power. In consideration that some possible technical problems with video-recording or other study procedures could occur, the investigators aim to increase the recruitment of participating teams by 20% per arm, to compensate for loss of statistical power due to a potential insufficient sample size. Hence, the investigators plan to have 35 scenarios per arm, for a total of 105 scenarios, which will include overall 315 residents who will be divided in teams of three.

STATISTICAL ANALYSIS

The c-DEV15plus scale, the performance and time to accomplish specific resuscitation interventions, workload, overall team performance and cardiopulmonary resuscitation metrics will be compared between groups with one-way ANOVA model, followed by the Tukey-Kramer multiple comparisons adjustment procedure in case of statistical significance. The outcomes will also be analyzed with a linear mixed model considering the team as a cluster to evaluate the influence of participants' characteristics on the outcome. To take into account the correlation of the observations within a team, the investigators will specify an undetermined correlation matrix. In case of a not normal distribution of the model residuals, the investigators will proceed with a transformation in order to normalize the distribution.

CONFIDENTIALITY AND PRIVACY PROTECTION

A written informed consent to take part into the study will be obtained from each participant. To ensure that the data collected remains confidential, all data and videos will be stored on password protected and secured hard-disk drives, that will be stored in locked filing cabinets located at the Department of Women's and Children's health, University of Padova, Italy. ;

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

• NCT number: NCT04619498
• Study type: Interventional
• Source: University of Padova
• Status: Completed
• Phase: N/A
• Start date: September 21, 2020
• Completion date: December 31, 2021