Evaluation of the Impact of Telemedicine in Pediatric Intensive Care Units

NCT05260710 | Unknown DMC

• 1 other identifier: 5.126.122
• Study Type: interventional
• Target: 1,760
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will be a cluster randomized controlled trial to assess the impact of telemedicine in Pediatric Intensive Care Units (PICU), through daily tele-rounds with a board certified physician and educational activities, in improving clinical-assistance indicators, as well as reducing the length of stay in the PICU.

Conditions

Telemedicine; Critical Care; Pediatric; Adolescent; Intensive Care Units, Pediatric

Keywords

Telemedicine; Pediatric Intensive Care Units; Randomized Controlled Clinical Trial; Technology

Outcome Measures

Primary Outcomes (1)

• Lenght of stay

  Time until discharge from the Pediatric intensive care unit

  From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days

Secondary Outcomes (5)

• To measure PICU mortality

  From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days

• To check the days free from mechanical ventilation

  From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days

• To measure the time of use of vasoactive drugs

  From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days

• To measure the time of use of broad-spectrum antibiotics

  From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days

• To measure the time of use of sedation/analgesia

  From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days

Study Arms (2)

Telemedicine intervention

EXPERIMENTAL

Tele-critical care + continuing education activities

Behavioral: Telemedicine Intervention

Usual Care

NO INTERVENTION

Usual Care

Interventions

Telemedicine Intervention BEHAVIORAL

Tele-Critical Care: 1) establishing a diagnosis 2) guiding the therapeutic approach and 3) performing clinical follow-up. Physicians will discuss all patients in the unit, bed by bed, evaluating the specific clinical situation of each hospitalized patient, according to the protocol developed by the study.The proposal is to maintain horizontal care (the patient is monitored from the 1st day of hospitalization until discharge) for all patients in the unit. \+ Continuing education activities: video classes and discussions of complex cases.

Telemedicine intervention

Eligibility Criteria

• Age: 29 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All children admitted to the pediatric ICU aged ≥29 days and \<18 years
• Length of stay of more than 8 hours and, in case of death, with a length of stay of more than 24 hours

You may not qualify if:

• Patients with incomplete medical records
• Incomplete data in the institution's database
• Patients whose guardians did not accept to participate in the study and/or who did not sign the informed consent form and the image use term.

Sponsors & Collaborators

• Hospital Moinhos de Vento: lead

Related Publications (16)

• Agência IBGE https://agenciadenoticias.ibge.gov.br/agencia-noticias/2012-agencia-de-notíci as/27614-ibge-divulga-distribuicao-de-utis-respiradores-medicos-e-enfermeiros: Acessado em 14 de novembro de 2020.

  BACKGROUND

• BRASIL. Ministério da Saúde. Diretrizes Operacionais para o Estabelecimento e o Funcionamento de Comitês de Monitoramento de Dados e de Segurança / Ministério da Saúde, Organização Mundial da Saúde. Brasília : Ministério da Saúde, 2008. 44 p.

  BACKGROUND

• Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012 Sep 4;345:e5661. doi: 10.1136/bmj.e5661. No abstract available.

  PMID: 22951546 BACKGROUND

• Chen J, Sun D, Yang W, Liu M, Zhang S, Peng J, Ren C. Clinical and Economic Outcomes of Telemedicine Programs in the Intensive Care Unit: A Systematic Review and Meta-Analysis. J Intensive Care Med. 2018 Jul;33(7):383-393. doi: 10.1177/0885066617726942. Epub 2017 Aug 22.

  PMID: 28826282 BACKGROUND

• DE AZEVEDO, Arimatéia Portela et al. Fatores que interferem no desempenho da utilização de leitos de unidade de terapia intensiva (UTI). Brazilian Journal of Health Review, v. 3, n. 4, p. 7421-7438, 2020.

  BACKGROUND

• Garingo A, Friedlich P, Chavez T, Tesoriero L, Patil S, Jackson P, Seri I. "Tele-rounding" with a remotely controlled mobile robot in the neonatal intensive care unit. J Telemed Telecare. 2016 Mar;22(2):132-8. doi: 10.1177/1357633X15589478. Epub 2015 Jun 26.

  PMID: 26116855 BACKGROUND

• Grundy BL, Crawford P, Jones PK, Kiley ML, Reisman A, Pao YH, Wilkerson EL, Gravenstein JS. Telemedicine in critical care: an experiment in health care delivery. JACEP. 1977 Oct;6(10):439-44. doi: 10.1016/s0361-1124(77)80239-6.

  PMID: 71365 BACKGROUND

• MINISTÉRIO DA SAÚDE. Portaria n. 3.432, de 12 de agosto de 1998. Estabelece Critérios de Classificação de Unidade de Terapia Intensiva (UTI). Diário Oficial da União n. 154; Poder Executivo, 13 ago. 1998. Disponível em: <www.medicinaintensiva.com.br/portaria-3432.htm>. Acesso em: 10 jan. 2010.

  BACKGROUND

• Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.

  PMID: 22036893 BACKGROUND

• PATRIDGE, Emily F.; BARDYN, Tania P. Research electronic data capture (REDCap). Journal of the Medical Library Association: JMLA, v. 106, n. 1, p. 142, 2018.

  BACKGROUND

• PARK, Heesun. SAS Institute, Inc. Cary, North Carolina. Sign, v. 2, n. 4, p. 1.

  BACKGROUND

• Pfrimmer DM, Roslien JJ. The Tele-ICU: a new dimension in critical care nursing education and practice. J Contin Educ Nurs. 2011 Aug;42(8):342-3. doi: 10.3928/00220124-20110722-03.

  PMID: 21800788 BACKGROUND

• Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012 Dec 26;308(24):2594-604. doi: 10.1001/jama.2012.87802.

  PMID: 23268518 BACKGROUND

• Jacovas VC, Chagas MEV, Constant HMRM, Alves SS, Krauzer JRM, Guerra LR, de Almeida Pires A, Gomes da Cunha L, Matte MCC, de Campos Moreira T, Cabral FC. Telemedicine in Pediatric Intensive Care Units: Perspectives From a Brazilian Experience. Curr Pediatr Rep. 2021;9(3):65-71. doi: 10.1007/s40124-021-00242-z. Epub 2021 Jul 12.

  PMID: 34277142 BACKGROUND

• de Oliveira Laguna Silva G, Konig Klever E, Castro da Rocha J, da Silva MMD, da Rosa de Amorim J, Cristina Jacovas V, Marina Simionato B, Gomes da Cunha L, Zaupa APB, Mafalda Krauzer JR, de Almeida Pires A, Cezar Cabral F, de Campos Moreira T, Rodrigues Moleda Constant HM. Evaluation of the use of telemedicine in pediatric intensive care units: a cluster-randomized trial. Postgrad Med. 2024 Aug;136(6):633-640. doi: 10.1080/00325481.2024.2388023. Epub 2024 Aug 5.

  PMID: 39093639 DERIVED

• Silva MMDD, Klever EK, Rocha JCD, Silva GOL, Amorim JDR, Dode AD, Simionato BM, Cunha LGD, Zaupa APB, Krauzer JRM, Pires AA, Cabral FC, Moreira TC, Constant HMRM. Impact of Telemedicine use on clinical care indicators of pediatric intensive care units: protocol for a cluster randomized clinical trial. Crit Care Sci. 2023 Dec 22;35(3):266-272. doi: 10.5935/2965-2774.20230223-en. eCollection 2023.

  PMID: 38133156 DERIVED

Study Officials

• Felipe C Cabral

  Hospital Moinhos de Vento

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felipe C Cabral

CONTACT

+55 (51) 98464-4901; felipe.cabral@hmv.org.br

Taís C Moreira

CONTACT

+55 (51) 3537-8350; tais.moreira@hmv.org.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Digital health coordinator

Model Details: Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label)

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 2, 2022
• Study Start: April 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available with the publication of the main study.
• Access Criteria: Data will be acessed through an online repository protected with password and for secondary analyses according to pre-specified plans.