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

NCT ID: NCT04619498

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-21
• Study Completion Date: 2021-12-31

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.

Conditions

Cardiac Arrest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PediAppRREST app

The teams assigned to the PediAppRREST arm will manage the simulated scenario of pediatric cardiac arrest using the new PediAppRREST tablet app as a cognitive aid.

Group Type: EXPERIMENTAL

PediAppRREST

Intervention Type: DEVICE

PediAppRREST is a new audiovisual interactive app for tablets developed to support the management of pediatric cardiac arrest. It sequentially displays directions on recommended management interventions. It was specifically designed to guide the team leader to perform resuscitation interventions in the sequence/timing and modality reported by the American Heart Association Pediatric Advanced Life Support (AHA-PALS) guidelines.

CtrlPALS+

The teams assigned to the CtrlPALS+ arm will manage the simulated scenario of pediatric cardiac arrest using the American Heart Association Pediatric Advanced Life Support (AHA-PALS) pocket reference card.

Group Type: ACTIVE_COMPARATOR

AHA-PALS pocket reference card

Intervention Type: OTHER

It is a 10 cm x 16.5 cm, full-color, 2-sided, 6-panel card that shows the American Heart Association Pediatric Advanced Life Support (AHA-PALS) treatment algorithms. By providing a quick reference tool, it serves as a cognitive aid for healthcare providers who either direct or participate in the management of pediatric respiratory and/or cardiovascular emergencies, including cardiac arrest.

CtrlPALS-

The teams assigned to the CtrlPALS- arm will manage the simulated scenario of pediatric cardiac arrest using no PALS-related cognitive aids.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PediAppRREST

PediAppRREST is a new audiovisual interactive app for tablets developed to support the management of pediatric cardiac arrest. It sequentially displays directions on recommended management interventions. It was specifically designed to guide the team leader to perform resuscitation interventions in the sequence/timing and modality reported by the American Heart Association Pediatric Advanced Life Support (AHA-PALS) guidelines.

Intervention Type: DEVICE

AHA-PALS pocket reference card

It is a 10 cm x 16.5 cm, full-color, 2-sided, 6-panel card that shows the American Heart Association Pediatric Advanced Life Support (AHA-PALS) treatment algorithms. By providing a quick reference tool, it serves as a cognitive aid for healthcare providers who either direct or participate in the management of pediatric respiratory and/or cardiovascular emergencies, including cardiac arrest.

Intervention Type: OTHER

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

• Minimum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florence

OTHER

Sponsor Role: collaborator

Catholic University of the Sacred Heart

OTHER

Sponsor Role: collaborator

Università degli Studi del Piemonte Orientale Amedeo Avogadro

OTHER

Sponsor Role: collaborator

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Silvia Bressan

Assistant professor, Attending Physician in Pediatric Emergency Medicine, MD, PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silvia Bressan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Padova

Francesco Corazza, MD

Role: PRINCIPAL_INVESTIGATOR

University of Padova

Locations

Azienda Ospedaliera Universitaria Meyer, University of Firenze

Florence, , Italy

Azienda Ospedaliera Universitaria Maggiore della Carità, Università del Piemonte Orientale

Novara, , Italy

Azienda Ospedale Università di Padova, University of Padova

Padua, , Italy

Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore

Roma, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 32788142 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32057946 (View on PubMed)

Corazza F, Arpone M, Tardini G, Stritoni V, Mormando G, Graziano A, Navalesi P, Fiorese E, Portalone S, De Luca M, Binotti M, Tortorolo L, Salvadei S, Nucci A, Monzani A, Genoni G, Bazo M, Cheng A, Frigo AC, Da Dalt L, Bressan S. Effectiveness of a Novel Tablet Application in Reducing Guideline Deviations During Pediatric Cardiac Arrest: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2327272. doi: 10.1001/jamanetworkopen.2023.27272.

Reference Type: DERIVED

PMID: 37535352 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34321297 (View on PubMed)

Other Identifiers

BIRD191291

Identifier Type: -

Identifier Source: org_study_id