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

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05408143
Collaborator
Children and Youth with Special Health Care Needs National Research Network (CYSHC) (Other)
300
1
2
21.2
14.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: CC
  • Device: enhanced telemedicine (ETM)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Anticipated Study Start Date :
Jun 15, 2022
Anticipated Primary Completion Date :
Feb 20, 2023
Anticipated Study Completion Date :
Mar 20, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number of days care provided in a medical setting [end of study(about 24 months)]

  2. 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

  1. Cost effectiveness of ETM [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. All cause infections on admission to the hospital [end of study(about 24 months)]

  3. Total numbers of clinic visits [end of study(about 24 months)]

  4. Total number of emergency department visits [end of study(about 24 months)]

  5. Total number of hospital days [end of study(about 24 months)]

  6. Total number of Pediatric Intensive Care Unit (PICU) days [end of study(about 24 months)]

  7. Total number of deaths [end of study(about 24 months)]

  8. Parent ratings of care assessed using the Consumer Assessment of Healthcare Providers and Systems Survey [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

Sponsors and Collaborators

  • The University of Texas Health Science Center, Houston
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ricardo A. Mosquera, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT05408143
Other Study ID Numbers:
  • HSC-MS-21-0829
  • 5 UA6MC31101-05-00
First Posted:
Jun 7, 2022
Last Update Posted:
Jun 7, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Ricardo A. Mosquera, Associate Professor, The University of Texas Health Science Center, Houston
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 7, 2022