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

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

Conditions

• Chronic Diseases in Children

Interventions

OTHER

Comprehensive care (CC) program

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.

DEVICE

Enhanced telemedicine (ETM)

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.

Sponsors & Collaborators

• The Systems and Policy Research Network

  collaborator UNKNOWN

• The University of Texas Health Science Center, Houston

  lead OTHER

Principal Investigators

• Ricardo A Mosquera, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-12

Primary Completion

2024-08-26

Completion

2024-08-26

FDA Device

Yes

Countries

• United States

Study Locations