Clinical trial NCT04619498: Effectiveness of an Interactive Cognitive Support Tablet App to Improve the Management of Pediatric Cardiac Arrest
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: cardiac arrest
resuscitation
cognitive aid
mobile app
emergency medicine
simulation
pediatrics
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: University of Florence
name: Catholic University of the Sacred Heart
name: Università degli Studi del Piemonte Orientale Amedeo Avogadro
First posted: 2020-11-06
Enrollment: 324
Sex: ALL
Minimum age (years): 24
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, three-parallel arm study
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* to be attending a medical residency training program in Pediatrics, Anesthesiology-Intensive Care or Emergency Medicine
* to be BLS (Basic Life Support) or P-BLS (Pediatric-Basic Life Support) or PALS (Pediatric Advanced Life Suport) or ALS (Advanced Life Support) or ACLS (Advanced Cardiac Life Support) certified, following the American Heart Association (AHA) or the European Resuscitation Council (ERC) courses
* to give consent to participate to the study and to be video-recorded.

Additionally, to be eligible for the role of team leader, residents must be PALS-certified according to AHA or ERC guidelines

Exclusion Criteria:

* to be unable to attend the simulation sessions because of personal leave, maternity/paternity leave, sick leave or training abroad
* participation in previous studies using the PediAppRREST app

Primary outcomes:
measure: Deviations from American Heart Association Pediatric Advanced Life Support (AHA-PALS) guidelines
timeFrame: Scenario will be video recorded and evaluated by two independent video reviewers. Outcome assessors will score teams' performance by means of the c-DEV15plus score using data extracted by video reviewers through study completion, an average of 15 months.
Secondary outcomes:
measure: Recognition of cardiac arrest (pulsenessness)
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the pulsessness recognition, through study completion, an average of 15 months.
measure: Time to cardiac arrest (pulsenessness) recognition
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the time to pulselessness recognition, through study completion, an average of 15 months.
measure: Performance of chest compressions
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the performance of chest compressions, through study completion, an average of 15 months.
measure: Time to start chest compressions from arrest recognition
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the time to start chest compressions, through study completion, an average of 15 months.
measure: Time to start chest compressions from the beginning of the scenario
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the time to start chest compressions, through study completion, an average of 15 months.
measure: Performance of ventilation
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the start of ventilation, through study completion, an average of 15 months.
measure: Time to start of ventilation from arrest recognition
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the time to start ventilation, through study completion, an average of 15 months.
measure: Time to start of ventilation from the beginning of the scenario
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the time to start ventilation, through study completion, an average of 15 months.
measure: Use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the use of a cardiopulmonary resuscitation board or a rigid surface underneath the manikin, through study completion, an average of 15 months.
measure: Time to use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin from arrest recognition
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the time to use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin, through study completion, an average of 15 months.
measure: Time to use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin from the beginning of the scenario
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the time to use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin, through study completion, an average of 15 months.
measure: Call for emergency team help
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the call for emergency team help, through study completion, an average of 15 months.
measure: Time to call for emergency team help from arrest recognition
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the time to call for emergency team help, through study completion, an average of 15 months.
measure: Time to call for emergency team help from the beginning of the scenario
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the time to call for emergency team help, through study completion, an average of 15 months.
measure: Use of electrocardiogram monitoring
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the use of electrocardiogram monitoring, through study completion, an average of 15 months.
measure: Time to start electrocardiogram monitoring from arrest recognition
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the time to start electrocardiogram monitoring, through study completion, an average of 15 months.
measure: Time to start electrocardiogram monitoring from the beginning of scenario
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the time to start electrocardiogram monitoring, through study completion, an average of 15 months.
measure: Administration of a correct first epinephrine
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the correct administration of the first epinephrine, through study completion, an average of 15 months.
measure: Time to first epinephrine administration from arrest recognition
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the time to the first epinephrine administration, through study completion, an average of 15 months.
measure: Time to first epinephrine administration from the beginning of the scenario
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the time to the first epinephrine administration, through study completion, an average of 15 months.
measure: Administration of a correct second epinephrine
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the correct administration of the second epinephrine dose, through study completion, an average of 15 months.
measure: Time to second epinephrine administration from arrest recognition
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the time to second epinephrine administration, through study completion, an average of 15 months.
measure: Time to second epinephrine administration from the beginning of the scenario
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the time to second epinephrine administration, through study completion, an average of 15 months.
measure: Treatment of reversible causes
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the correct treatment of reversible causes, through study completion, an average of 15 months.
measure: Time to treatment of reversible causes from arrest recognition
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the time to treatment of reversible causes, through study completion, an average of 15 months.
measure: Time to treatment of reversible causes from the beginning of the scenario
timeFrame: Scenario will be video recorded and successively two independent video reviewers will assess the time to treatment of reversible causes, through study completion, an average of 15 months.
measure: Usability of the app - System Usability Scale
timeFrame: Questionnaires will be completed after each simulated scenario through study completion, an average of 15 months.
measure: Usability of the app - Open-ended questions
timeFrame: Questionnaires will be completed after each simulated scenario through study completion, an average of 15 months.
measure: Team leaders' workload
timeFrame: Questionnaires will be completed by team leaders after each simulated scenario through study completion, an average of 15 months.
measure: Cardiopulmonary resuscitation (CPR) quality - Mean chest compression rate
timeFrame: CPR quality data will be extracted by the manikin's software after each simulated scenario, through study completion, an average of 15 months.
measure: Cardiopulmonary resuscitation (CPR) quality metrics - Mean chest compression depth
timeFrame: CPR quality data will be extracted by the manikin's software after each simulated scenario, through study completion, an average of 15 months.
measure: Cardiopulmonary resuscitation (CPR) quality metrics - Compression depth correctness
timeFrame: CPR quality data will be extracted by the manikin's software after each simulated scenario, through study completion, an average of 15 months.
measure: Cardiopulmonary resuscitation (CPR) quality metrics - Chest compressions fraction
timeFrame: CPR quality data will be extracted by the manikin's software after each simulated scenario, through study completion, an average of 15 months.
measure: Team resuscitation performance
timeFrame: Scenario will be video recorded and successively evaluated by two independent video reviewers. Outcome assessors will score teams' performance by means of CPT using data extracted by video reviewers, through study completion, an average of 15 months.
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Meyer, University of Firenze
city: Novara
country: Italy
facility: Azienda Ospedaliera Universitaria Maggiore della Carità, Università del Piemonte Orientale
city: Padova
country: Italy
facility: Azienda Ospedale Università di Padova, University of Padova
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore
Study officials:
affiliation: University of Padova
name: Silvia Bressan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Padova
name: Francesco Corazza, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Corazza F, Snijders D, Arpone M, Stritoni V, Martinolli F, Daverio M, Losi MG, Soldi L, Tesauri F, Da Dalt L, Bressan S. Development and Usability of a Novel Interactive Tablet App (PediAppRREST) to Support the Management of Pediatric Cardiac Arrest: Pilot High-Fidelity Simulation-Based Study. JMIR Mhealth Uhealth. 2020 Oct 1;8(10):e19070. doi: 10.2196/19070.
citation: Wolfe HA, Morgan RW, Zhang B, Topjian AA, Fink EL, Berg RA, Nadkarni VM, Nishisaki A, Mensinger J, Sutton RM; American Heart Association's Get With the Guidelines-Resuscitation Investigator. Deviations from AHA guidelines during pediatric cardiopulmonary resuscitation are associated with decreased event survival. Resuscitation. 2020 Apr;149:89-99. doi: 10.1016/j.resuscitation.2020.01.035. Epub 2020 Feb 11.
citation: Corazza F, Arpone M, Snijders D, Cheng A, Stritoni V, Ingrassia PL, De Luca M, Tortorolo L, Frigo AC, Da Dalt L, Bressan S. PediAppRREST: effectiveness of an interactive cognitive support tablet app in reducing deviations from guidelines in the management of paediatric cardiac arrest: protocol for a simulation-based randomised controlled trial. BMJ Open. 2021 Jul 28;11(7):e047208. doi: 10.1136/bmjopen-2020-047208.