About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Major heart disease
Mitochondrial disorders
Active cancer
Do-Not-Resuscitate (DNR) order
Trial design
Parallel
Treatments tested in this trial
CC
Other interventionTo 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).
enhanced telemedicine (ETM)
DeviceAn 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.
Treatment groups
Trial outcomes
Primary outcomes
Number of days care provided in a medical setting
Total number of episodes of serious illnesses (causing death, pediatric ICU admission, and hospital stay > 7d).
Secondary outcomes
Cost effectiveness of ETM
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
All cause infections on admission to the hospital
Total numbers of clinic visits
Total number of emergency department visits
Sponsors and contacts
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The University of Texas Health Science Center, Houston
Lead sponsor
Children and Youth with Special Health Care Needs National Research Network (CYSHC)
Collaborator