Clinical trial NCT05408143: An Enhanced Home-Based Telemedicine Program Using Remote Examination Devices for Children With Medical Complexity
Official title: An Enhanced Home-Based Telemedicine Program Using Remote Examination Devices for Children With Medical Complexity Receiving Comprehensive Care: a Single-Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Diseases in Children
Keywords: Comprehensive Care
Telemedicine enhanced with TytoCare devices.
Telemedicine
children with medical complexity
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Children and Youth with Special Health Care Needs National Research Network (CYSHC)
First posted: 2022-06-07
Enrollment: 300
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Number of days care provided in a medical setting
timeFrame: end of study(about 24 months)
measure: Total number of episodes of serious illnesses (causing death, pediatric ICU admission, and hospital stay > 7d).
timeFrame: end of study(about 24 months)
Secondary outcomes:
measure: Cost effectiveness of ETM
timeFrame: end of study(about 24 months)
measure: All cause infections on admission to the hospital
timeFrame: end of study(about 24 months)
measure: Total numbers of clinic visits
timeFrame: end of study(about 24 months)
measure: Total number of emergency department visits
timeFrame: end of study(about 24 months)
measure: Total number of hospital days
timeFrame: end of study(about 24 months)
measure: Total number of Pediatric Intensive Care Unit (PICU) days
timeFrame: end of study(about 24 months)
measure: Total number of deaths
timeFrame: end of study(about 24 months)
measure: Parent ratings of care assessed using the Consumer Assessment of Healthcare Providers and Systems Survey
timeFrame: end of study(about 24 months)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Ricardo A Mosquera, MD
role: PRINCIPAL_INVESTIGATOR
References: