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

NCT04619498 | Completed

• 1 other identifier: BIRD191291
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 4

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.

Conditions

Cardiac Arrest

Keywords

cardiac arrest; resuscitation; cognitive aid; mobile app; emergency medicine; simulation; pediatrics

Outcome Measures

Primary Outcomes (1)

• Deviations from American Heart Association Pediatric Advanced Life Support (AHA-PALS) guidelines

  Deviations from AHA-PALS guidelines recommendations are defined as delays and errors according to a novel checklist we derived from a previously published checklist, denominated c-DEV (circulation-deviations), published by Wolfe et al. (2020), by integrating it with evidence-based guidelines, previously reported scoring tools and checklists. We named our new modified checklist c-DEV15plus (circulation-deviations 15 plus). It includes 15 items, which represent correct critical actions for pediatric resuscitation. Each item of the c-DEV15plus is scored either as 0, when the action is performed correctly and timely, as described in the item, or as 1, when the action is not undertaken, undertaken incorrectly, or with wrong timing. The sum of the points attributed to the items represents the c-DEV15plus total score, hence ranging from a minimum of 0 to a maximum of 15, with higher scores corresponding to a higher number of deviations from the guidelines and a worse performance.

  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 (34)

• Recognition of cardiac arrest (pulsenessness)

  Scenario will be video recorded and successively two independent video reviewers will assess the pulsessness recognition, through study completion, an average of 15 months.

• Time to cardiac arrest (pulsenessness) recognition

  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.

• Performance of chest compressions

  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.

• Time to start chest compressions from arrest recognition

  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.

• Time to start chest compressions from the beginning of the scenario

  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.

Study Arms (3)

PediAppRREST app

EXPERIMENTAL

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.

Device: PediAppRREST

CtrlPALS+

ACTIVE COMPARATOR

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.

Other: AHA-PALS pocket reference card

CtrlPALS-

NO INTERVENTION

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

Interventions

PediAppRREST 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.

PediAppRREST app

AHA-PALS pocket reference card 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+

Eligibility Criteria

• Age: 24 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead
• University of Florence: collaborator
• Catholic University of the Sacred Heart: collaborator
• Università degli Studi del Piemonte Orientale Amedeo Avogadro: collaborator

Study Sites (4)

Azienda Ospedaliera Universitaria Meyer, University of Firenze

Florence, Italy

Location

Azienda Ospedaliera Universitaria Maggiore della Carità, Università del Piemonte Orientale

Novara, Italy

Location

Azienda Ospedale Università di Padova, University of Padova

Padua, Italy

Location

Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore

Roma, Italy

Location

Related Publications (4)

• 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.

  PMID: 32788142 BACKGROUND

• 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.

  PMID: 32057946 BACKGROUND

• 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.

  PMID: 37535352 DERIVED

• 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.

  PMID: 34321297 DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Silvia Bressan, MD, PhD

  University of Padova

  PRINCIPAL INVESTIGATOR

• Francesco Corazza, MD

  University of Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of this study, blinding of the participants, investigators and outcome assessors will not be possible. However, data analyses will be performed by a statistician who will be blinded to the allocation arm (PediAppRREST tablet app, PALS pocket reference card, no cognitive aid).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Attending Physician in Pediatric Emergency Medicine, MD, PhD.

Model Details: Randomized, controlled, three-parallel arm study

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: November 6, 2020
• Study Start: September 21, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)