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

An Enhanced Home-Based Telemedicine Program Using Remote Examination Devices for Children With Medical Complexity Receiving Comprehensive Care: a Single-Center Randomized Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Diseases in Children
• Intervention / Treatment: Other: CC; Device: enhanced telemedicine (ETM)

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diana J Martinez Castillo; Phone Number: 713-500-5359; Email: Diana.J.MartinezCastillo@uth.tmc.edu
• Study Contact Backup: Name: Ricardo A Mosquera, MD; Phone Number: 713-500-5650; Email: Ricardo.A.Mosquera@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Diana J Martinez Castillo; Phone Number: 713-500-5359; Email: Diana.J.MartinezCastillo@uth.tmc.edu
      • Contact: Ricardo A Mosquera, MD; Phone Number: 713-500-5650; Email: Ricardo.A.Mosquera@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 14 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: usual CC (with conventional telemedicine)	Other: CC; 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).
Experimental: comprehensive care (CC) augmented with enhanced telemedicine (ETM)	Other: CC; 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).; Device: enhanced telemedicine (ETM); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)
Total number of Pediatric Intensive Care Unit (PICU) days		end of study(about 24 months)
Total number of deaths		end of study(about 24 months)
Parent ratings of care assessed using the Consumer Assessment of Healthcare Providers and Systems Survey	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.	end of study(about 24 months)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Children and Youth with Special Health Care Needs National Research Network (CYSHC)
• Investigators: Principal Investigator: Ricardo A Mosquera, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Anticipated): November 1, 2025
• Study Completion (Anticipated): November 1, 2025

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Telemedicine; Comprehensive Care; Telemedicine enhanced with TytoCare devices.; children with medical complexity
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: HSC-MS-21-0829; 5 UA6MC31101-05-00 (Other Grant/Funding Number: HRSA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No