Evaluation of the Impact of Telemedicine in Pediatric Intensive Care Units

Not Applicable

• Conditions: Pediatric; Adolescent; Critical Care; Intensive Care Units, Pediatric; Telemedicine
• Interventions: Behavioral: Telemedicine Intervention

• Registration Number: NCT05260710
• Lead Sponsor: Hospital Moinhos de Vento

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.

Study Timeline

• Study First Submitted: 2022-02-18
• Study First Submitted QC: 2022-02-18
• Status Verified: 2022-03
• Study First Posted: 2022-03-02
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-29
• Study Start: 2022-04-01
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1760

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedicine intervention	Telemedicine Intervention	Tele-critical care + continuing education activities

Primary Outcome Measures

Name	Time	Method
Lenght of stay	From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days	Time until discharge from the Pediatric intensive care unit

Secondary Outcome Measures

Name	Time	Method
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 vasoactive drugs by patients hospitalized in PICUs
To measure PICU mortality	From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days	To measure the mortality rate in PICUs
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 check the days free from mechanical ventilation of patients hospitalized in PICUs
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 broad-spectrum antibiotics in patients hospitalized in PICUs
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	To measure the time of use of sedation/analgesia in patients hospitalized in PICUs