Clinical trial NCT05260710: Evaluation of the Impact of Telemedicine in Pediatric Intensive Care Units
Official title: Evaluation of the Impact of Telemedicine Use on Clinical Care Indicators in Pediatric Intensive Care Units: Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Telemedicine
Critical Care
Pediatric
Adolescent
Intensive Care Units, Pediatric
Keywords: Telemedicine
Pediatric Intensive Care Units
Randomized Controlled Clinical Trial
Technology
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 1760
Sex: ALL
Minimum age (years): 29
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: This is a parallel cluster randomized controlled trial in pediatric intensive care units in Brazil.

PICUs is the unit of randomization. All patients admitted to the PICUs selected to participate in the project will be included in the study allocated to the control or intervention group as their respective hospitals are randomized.

Intervention group: Tele-rounds are case discussions with remote pediatric intensive care physicians and physicians from other specialties, such as a radiologist, infectious disease specialist, for the debate on conducts based on the best scientific evidence. Additionally, concurrently with the period of application of the intervention, continuing education activities will be made available to all professionals from the teams of the participating centers. Education activities are held monthly and consist of video classes and discussions of complex cases.

Control group: This group will maintain the usual care offered by the participating centers.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Lenght of stay
timeFrame: From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days
Secondary outcomes:
measure: To measure PICU mortality
timeFrame: From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days
measure: To check the days free from mechanical ventilation
timeFrame: From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days
measure: To measure the time of use of vasoactive drugs
timeFrame: From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days
measure: To measure the time of use of broad-spectrum antibiotics
timeFrame: From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days
measure: To measure the time of use of sedation/analgesia
timeFrame: From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Moinhos de Vento
name: Felipe C Cabral
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: PARK, Heesun. SAS Institute, Inc. Cary, North Carolina. Sign, v. 2, n. 4, p. 1.
citation: 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.
citation: 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.
citation: 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.