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An Enhanced Home-Based Telemedicine Program Using Remote Examination Devices for Children With Medical Complexity

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05408143
Enrollment
300
Registered
2022-06-07
Start date
2022-07-12
Completion date
2025-11-01
Last updated
2023-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Diseases in Children

Keywords

Comprehensive Care, Telemedicine enhanced with TytoCare devices., Telemedicine, children with medical complexity

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.

Interventions

OTHERCC

To promote prompt effective care for medically complex children at all hours, we developed an outpatient comprehensive care (CC) program at the University of Texas Health Science Center at Houston (UTH) that now includes a hospital consultation service by the outpatient CC providers (the hospital component) and a conventional telemedicine (CTM) audio-visual program (the home component).

DEVICEenhanced telemedicine (ETM)

An enhanced telemedicine program (using HIPAA-compliant, mobile TytoCareTM devices) will be added to CC to allow providers to remotely visualize the skin, throat, & ears, auscultate the heart & lungs, and measure illnesses during clinic hours and chronic illnesses during the detailed patient evaluation to be conducted at least every 6 months by virtual patient rounds in the home. These visits will involve the parent(s), the PCP, and if needed any of 10 specialists, particularly pulmonology, gastroenterology, neurology, and physical medicine and rehabilitation. A social worker, nutritionist, or psychologist will be involved as needed. Each PCP will perform 2-3 virtual patient rounds per week to proactively identify medical problems, suboptimal adherence to treatment, dosing errors, or other problems and intervene before CMC develop a serious illness or require avoidable clinic visits, Emergency Department visits, or hospitalizations.

Sponsors

Children and Youth with Special Health Care Needs National Research Network (CYSHC)
CollaboratorUNKNOWN
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of days care provided in a medical settingend of study(about 24 months)
Total number of episodes of serious illnesses (causing death, pediatric ICU admission, and hospital stay > 7d).end of study(about 24 months)

Secondary

MeasureTime frameDescription
Total numbers of clinic visitsend of study(about 24 months)
Total number of emergency department visitsend of study(about 24 months)
Total number of hospital daysend of study(about 24 months)
Cost effectiveness of ETMend of study(about 24 months)this is defined strictly as a reduction in serious illnesses without an increase in health system costs, a decrease in health system costs without an increase in serious illnesses, or a reduction in both
Total number of deathsend of study(about 24 months)
Parent ratings of care assessed using the Consumer Assessment of Healthcare Providers and Systems Surveyend of study(about 24 months)This survey consists of 5 questions. The first 4 are scored from 1(never)-4(always) for a maximum score of 16 , a higher number indicating better care. The fifth question is scored form 0-10 a higher number indicating a better provider.
Total number of Pediatric Intensive Care Unit (PICU) daysend of study(about 24 months)
All cause infections on admission to the hospitalend of study(about 24 months)

Countries

United States

Contacts

Primary ContactRicardo A Mosquera, MD
Ricardo.A.Mosquera@uth.tmc.edu713-500-5650
Backup ContactDiana J Martinez Castillo
Diana.J.MartinezCastillo@uth.tmc.edu713-500-5359

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026