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

Not Applicable

Recruiting

• Conditions: Chronic Diseases in Children
• Interventions: Other: CC; Device: enhanced telemedicine (ETM)

• Registration Number: NCT05408143
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-20
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-07
• Study Start: 2022-07-12
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-12
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
comprehensive care (CC) augmented with enhanced telemedicine (ETM)	CC	-
usual CC (with conventional telemedicine)	CC	-
comprehensive care (CC) augmented with enhanced telemedicine (ETM)	enhanced telemedicine (ETM)	-

Primary Outcome Measures

Name	Time	Method
Total number of episodes of serious illnesses (causing death, pediatric ICU admission, and hospital stay > 7d).	end of study(about 24 months)
Number of days care provided in a medical setting	end of study(about 24 months)

Secondary Outcome Measures

Name	Time	Method
Total number of deaths	end of study(about 24 months)
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
Total number of hospital days	end of study(about 24 months)
Total number of emergency department visits	end of study(about 24 months)
Total numbers of clinic visits	end of study(about 24 months)
All cause infections on admission to the hospital	end of study(about 24 months)
Total number of Pediatric Intensive Care Unit (PICU) days	end of study(about 24 months)
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.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States