Evaluation of the Impact of Telemedicine in Pediatric Intensive Care Units

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Impact of Telemedicine Use on Clinical Care Indicators in Pediatric Intensive Care Units: Cluster Randomized Controlled Trial

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

Intervention / Treatment
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* Behavioral: Telemedicine Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 29 Days
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine intervention<br>Tele-critical care + continuing education activities | Behavioral: Telemedicine Intervention<br>* 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.<br>|
| No Intervention: Usual Care<br>Usual Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Pediatric Intensive Care Units, Randomized Controlled Clinical Trial, Technology