Evaluation of the Impact of Telemedicine in Pediatric Intensive Care Units

March 14, 2022 updated by: Felipe Cezar Cabral, Hospital Moinhos de Vento

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1760

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Experimental: Telemedicine intervention
Tele-critical care + continuing education activities
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lenght of stay
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Moinhos de Vento

Investigators

  • Principal Investigator: Felipe C Cabral, Hospital Moinhos de Vento

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 18, 2022

First Submitted That Met QC Criteria

February 18, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5.126.122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

With the publication of the main study the IPD will be available to researchers not members of the study.

IPD Sharing Time Frame

The data will become available with the publication of the main study.

IPD Sharing Access Criteria

Data will be acessed through an online repository protected with password and for secondary analyses according to pre-specified plans.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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