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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine intervention | Experimental | Tele-critical care + continuing education activities |
|
| Usual Care | No Intervention | Usual Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| To check the days free from mechanical ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Felipe C Cabral | Hospital Moinhos de Vento | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 22951546 | 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. | |
| 28826282 |
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With the publication of the main study the IPD will be available to researchers not members of the study.
The data will become available with the publication of the main study.
Data will be acessed through an online repository protected with password and for secondary analyses according to pre-specified plans.
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Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label)
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|
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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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. |
| 26116855 | 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. |
| 71365 | 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. |
| 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. |
| 22036893 | 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. |
| 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. |
| 21800788 | 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. |
| 23268518 | 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. |
| 34277142 | 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. |
| 39093639 | Derived | 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. |
| 38133156 | 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. |