An Enhanced Home-Based Telemedicine Program Using Remote Examination Devices for Children With Medical Complexity
2 other identifiers
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2022
CompletedFirst Posted
Study publicly available on registry
June 7, 2022
CompletedStudy Start
First participant enrolled
July 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedMay 12, 2023
May 1, 2023
3.3 years
April 20, 2022
May 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of days care provided in a medical setting
end 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 Outcomes (8)
Cost effectiveness of ETM
end of study(about 24 months)
All cause infections on admission to the hospital
end of study(about 24 months)
Total numbers of clinic visits
end of study(about 24 months)
Total number of emergency department visits
end of study(about 24 months)
Total number of hospital days
end of study(about 24 months)
- +3 more secondary outcomes
Study Arms (2)
usual CC (with conventional telemedicine)
ACTIVE COMPARATORcomprehensive care (CC) augmented with enhanced telemedicine (ETM)
EXPERIMENTALInterventions
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).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Major heart disease
- Mitochondrial disorders
- Active cancer
- Do-Not-Resuscitate (DNR) order
- Patients receiving compassionate care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Ricardo A Mosquera, MD
The University of Texas Health Science Center, Houston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 20, 2022
First Posted
June 7, 2022
Study Start
July 12, 2022
Primary Completion
November 1, 2025
Study Completion
November 1, 2025
Last Updated
May 12, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share