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Completed

NCT Number: NCT05408143

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

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 and oxygen saturation, auscultate the heart & lungs, and view the skin, throat, and tympanic membranes in the home.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive care (CC) program

Other

To promote prompt effective care for medically complex children at all hours, the investigators developed an outpatient comprehensive care (CC) program at the University of Texas Health Science Center at Houston, which includes 1) a clinic component with both specialist and primary care in the same clinic, 24/7 direct cell phone access to PCPs at all hours, same weekday care for acute illnesses, and a high staff-to-patient-ratio; 2) a hospital component with consultation service provided by PCPs to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge planning; and 3) a conventional telemedicine (CTM) program during regular clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct appropriate follow-up visits.

enhanced telemedicine (ETM)

Device

An enhanced telemedicine program (using the HIPAA-compliant, mobile TytoCare exam kit device) 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 primary care physician (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.

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

    Time frame: end 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

  2. Number of Hospital Admissions Due to All-Cause Infections

    Time frame: end of study(about 24 months)

  3. Average Numbers of Clinic Visits

    Time frame: end of study(about 24 months)

  4. Average Total Number of Emergency Department Visits

    Time frame: end of study(about 24 months)

  5. Average Number of Hospital Days

    Time frame: end of study(about 24 months)

  6. Average Number of Pediatric Intensive Care Unit (PICU) Days

    Time frame: end of study(about 24 months)

  7. Total Number of Deaths

    Time frame: end of study(about 24 months)

  8. Parent Ratings of Care Assessed Using the Consumer Assessment of Healthcare Providers and Systems Survey

    Time frame: end 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • The Systems and Policy Research Network

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2022
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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