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

NCT ID: NCT05408143

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-12
• Study Completion Date: 2025-11-01

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

Conditions

Chronic Diseases in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

usual CC (with conventional telemedicine)

Group Type: ACTIVE_COMPARATOR

CC

Intervention Type: OTHER

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).

comprehensive care (CC) augmented with enhanced telemedicine (ETM)

Group Type: EXPERIMENTAL

CC

Intervention Type: OTHER

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)

Intervention Type: 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.

Interventions

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).

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children and Youth with Special Health Care Needs National Research Network (CYSHC)

UNKNOWN

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Ricardo A. Mosquera

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ricardo A Mosquera, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ricardo A Mosquera, MD

Role: CONTACT

Ricardo.A.Mosquera@uth.tmc.edu

713-500-5650

Diana J Martinez Castillo

Role: CONTACT

Diana.J.MartinezCastillo@uth.tmc.edu

713-500-5359

Facility Contacts

Ricardo A Mosquera, MD

Role: primary

Ricardo.A.Mosquera@uth.tmc.edu

713-500-5650

Diana J Martinez Castillo

Role: backup

Diana.J.MartinezCastillo@uth.tmc.edu

713-500-5359

Other Identifiers

5 UA6MC31101-05-00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HSC-MS-21-0829

Identifier Type: -

Identifier Source: org_study_id