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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorThe University of Texas Health Science Center, Houston

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • CC

    Other intervention

    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).

  • enhanced telemedicine (ETM)

    Device

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: usual CC (with conventional telemedicine)Active comparator 1 intervention
Group B: comprehensive care (CC) augmented with enhanced telemedicine (ETM)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of days care provided in a medical setting

Time frame
end of study(about 24 months)
2

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

Time frame
end of study(about 24 months)

Secondary outcomes

1

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

Time frame
end of study(about 24 months)
2

All cause infections on admission to the hospital

Time frame
end of study(about 24 months)
3

Total numbers of clinic visits

Time frame
end of study(about 24 months)
4

Total number of emergency department visits

Time frame
end of study(about 24 months)

Other outcomes

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