An Enhanced Home-Based Telemedicine Program Using Remote Examination Devices for Children With Medical Complexity Receiving Comprehensive Care: a Single-Center Randomized Controlled Trial

The University of Texas Health Science Center, Houston1 site in 1 country300 target enrollmentJuly 12, 2022

ConditionsChronic Diseases in Children

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Diseases in Children
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 300
Locations: 1
Primary Endpoint: Total number of episodes of serious illnesses (causing death, pediatric ICU admission, and hospital stay > 7d).
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess if the benefits for children with medical complexity (CMC) receiving comprehensive care (CC) in an enhanced medical home can be further improved by enhanced telemedicine program (ETM) provided during clinic hours using mobile devices to measure temperature& oxygen saturation, auscultate the heart & lungs, and view the skin, throat, & tympanic membranes in the home.

Registry

clinicaltrials.gov

Start Date

July 12, 2022

End Date

November 1, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Ricardo A. Mosquera

Associate Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

•Greater than or equal to 2 hospitalizations or greater than or equal to 1 ICU admission in the year before joining the comprehensive care program
•Greater than 50 percent estimated risk of hospitalization without our care as judged by the medical director

Exclusion Criteria

•Major heart disease
•Mitochondrial disorders
•Active cancer
•Do-Not-Resuscitate (DNR) order
•Patients receiving compassionate care

Outcomes

Primary Outcomes

Total number of episodes of serious illnesses (causing death, pediatric ICU admission, and hospital stay > 7d).

Time Frame: end of study(about 24 months)

Number of days care provided in a medical setting

Time Frame: end of study(about 24 months)

Secondary Outcomes

Cost effectiveness of ETM(end of study(about 24 months))
Total number of hospital days(end of study(about 24 months))
Total number of deaths(end of study(about 24 months))
Total number of emergency department visits(end of study(about 24 months))
Total numbers of clinic visits(end of study(about 24 months))
All cause infections on admission to the hospital(end of study(about 24 months))
Total number of Pediatric Intensive Care Unit (PICU) days(end of study(about 24 months))
Parent ratings of care assessed using the Consumer Assessment of Healthcare Providers and Systems Survey(end of study(about 24 months))