Evaluation of the Impact of Telemedicine in Pediatric Intensive Care Units

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05260710
• Other study ID #: 5.126.122
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 2023

Study information

• Verified date: March 2022
• Source: Hospital Moinhos de Vento
• Contact: Felipe C Cabral
• Phone: +55 (51) 98464-4901
• Email: felipe.cabral[@]hmv.org.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Telemedicine Intervention
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Moinhos de Vento

References & Publications (14)

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

Outcome

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