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

Primary Purpose

Chronic Diseases in Children

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CC
enhanced telemedicine (ETM)
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Diseases in Children focused on measuring Comprehensive Care, Telemedicine enhanced with TytoCare devices., Telemedicine, children with medical complexity

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

usual CC (with conventional telemedicine)

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

Arm Description

Outcomes

Primary Outcome Measures

Number of days care provided in a medical setting
Total number of episodes of serious illnesses (causing death, pediatric ICU admission, and hospital stay > 7d).

Secondary Outcome Measures

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
All cause infections on admission to the hospital
Total numbers of clinic visits
Total number of emergency department visits
Total number of hospital days
Total number of Pediatric Intensive Care Unit (PICU) days
Total number of deaths
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.

Full Information

First Posted
April 20, 2022
Last Updated
May 10, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Children and Youth with Special Health Care Needs National Research Network (CYSHC)
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1. Study Identification

Unique Protocol Identification Number
NCT05408143
Brief Title
An Enhanced Home-Based Telemedicine Program Using Remote Examination Devices for Children With Medical Complexity
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Children and Youth with Special Health Care Needs National Research Network (CYSHC)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diseases in Children
Keywords
Comprehensive Care, Telemedicine enhanced with TytoCare devices., Telemedicine, children with medical complexity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
usual CC (with conventional telemedicine)
Arm Type
Active Comparator
Arm Title
comprehensive care (CC) augmented with enhanced telemedicine (ETM)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
CC
Intervention Description
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
Device
Intervention Name(s)
enhanced telemedicine (ETM)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of days care provided in a medical setting
Time Frame
end of study(about 24 months)
Title
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 Outcome Measure Information:
Title
Cost effectiveness of ETM
Description
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)
Title
All cause infections on admission to the hospital
Time Frame
end of study(about 24 months)
Title
Total numbers of clinic visits
Time Frame
end of study(about 24 months)
Title
Total number of emergency department visits
Time Frame
end of study(about 24 months)
Title
Total number of hospital days
Time Frame
end of study(about 24 months)
Title
Total number of Pediatric Intensive Care Unit (PICU) days
Time Frame
end of study(about 24 months)
Title
Total number of deaths
Time Frame
end of study(about 24 months)
Title
Parent ratings of care assessed using the Consumer Assessment of Healthcare Providers and Systems Survey
Description
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.
Time Frame
end of study(about 24 months)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ricardo A Mosquera, MD
Phone
713-500-5650
Email
Ricardo.A.Mosquera@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Diana J Martinez Castillo
Phone
713-500-5359
Email
Diana.J.MartinezCastillo@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo A Mosquera, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo A Mosquera, MD
Phone
713-500-5650
Email
Ricardo.A.Mosquera@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Diana J Martinez Castillo
Phone
713-500-5359
Email
Diana.J.MartinezCastillo@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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