Telemedicine Clinical Trial
Official title:
Evaluation of the Impact of Telemedicine Use on Clinical Care Indicators in Pediatric Intensive Care Units: Cluster Randomized Controlled Trial
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.
Status | Not yet recruiting |
Enrollment | 1760 |
Est. completion date | December 2023 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Hospital Moinhos de Vento |
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.
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.
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. — View 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. — View 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.
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. — View 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. — View 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 Jul 12:1-7. doi: 10.1007/s40124-021-00242-z. [Epub ahead of print] Review. — View 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.
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche 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. Review. — View Citation
PARK, Heesun. SAS Institute, Inc. Cary, North Carolina. Sign, v. 2, n. 4, p. 1.
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.
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. — View 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. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | To measure PICU mortality | To measure the mortality rate in PICUs | From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days | |
Secondary | To check the days free from mechanical ventilation | To check the days free from mechanical ventilation of patients hospitalized in PICUs | From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days | |
Secondary | To measure the time of use of vasoactive drugs | To measure the time of use of vasoactive drugs by patients hospitalized in PICUs | From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days | |
Secondary | To measure the time of use of broad-spectrum antibiotics | To measure the time of use of broad-spectrum antibiotics in patients hospitalized in PICUs | From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days | |
Secondary | To measure the time of use of sedation/analgesia | To measure the time of use of sedation/analgesia in patients hospitalized in PICUs | From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days |
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