Trial Outcomes & Findings for An Enhanced Home-Based Telemedicine Program Using Remote Examination Devices for Children With Medical Complexity (NCT NCT05408143)

NCT ID: NCT05408143

Last Updated: 2026-08-14

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

254 participants

Primary outcome timeframe

end of study(about 24 months)

Results posted on

2026-08-14

Participant Flow

Participant milestones

Participant milestones
Measure
Comprehensive Care (CC) Program
Comprehensive care (CC) program: To promote prompt effective care for medically complex children at all hours, the investigators developed an outpatient comprehensive care (CC) program at the University of Texas Health Science Center at Houston, which includes 1) a clinic component with both specialist and primary care in the same clinic, 24/7 direct cell phone access to PCPs at all hours, same weekday care for acute illnesses, and a high staff-to-patient-ratio; 2) a hospital component with consultation service provided by PCPs to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge planning; and 3) a conventional telemedicine (CTM) program during regular clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct appropriate follow-up visits.
Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM)
To promote care for medically complex children, investigators developed an outpatient CC program, with: a clinic component with both specialist \& primary care, 24/7 direct phone access to PCPs, same weekday care for acute illnesses, and a high staff-to-patient-ratio; a hospital component with PCP consultations to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge; and a conventional telemedicine program during clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct follow-ups. An enhanced telemedicine program (mobile TytoCare exam kit device) will be added 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 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 primary care physician (PCP), and if needed, any of 10 specialists. A social worker, nutritionist, or psychologist will be involved as needed. Each PCP will perform 2-3 virtual rounds weekly to 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, ED visits, or hospitalizations.
Overall Study
STARTED
124
130
Overall Study
COMPLETED
106
102
Overall Study
NOT COMPLETED
18
28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Comprehensive Care (CC) Program
n=124 Participants
Comprehensive care (CC) program: To promote prompt effective care for medically complex children at all hours, the investigators developed an outpatient comprehensive care (CC) program at the University of Texas Health Science Center at Houston, which includes 1) a clinic component with both specialist and primary care in the same clinic, 24/7 direct cell phone access to PCPs at all hours, same weekday care for acute illnesses, and a high staff-to-patient-ratio; 2) a hospital component with consultation service provided by PCPs to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge planning; and 3) a conventional telemedicine (CTM) program during regular clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct appropriate follow-up visits.
Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM)
n=130 Participants
To promote care for medically complex children, investigators developed an outpatient CC program, with: a clinic component with both specialist \& primary care, 24/7 direct phone access to PCPs, same weekday care for acute illnesses, and a high staff-to-patient-ratio; a hospital component with PCP consultations to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge; and a conventional telemedicine program during clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct follow-ups. An enhanced telemedicine program (mobile TytoCare exam kit device) will be added 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 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 primary care physician (PCP), and if needed, any of 10 specialists. A social worker, nutritionist, or psychologist will be involved as needed. Each PCP will perform 2-3 virtual rounds weekly to 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, ED visits, or hospitalizations.
Total
n=254 Participants
Total of all reporting groups
Age, Continuous
6.4 years
STANDARD_DEVIATION 3.95 • n=11 Participants
6.4 years
STANDARD_DEVIATION 4.04 • n=11 Participants
6.4 years
STANDARD_DEVIATION 3.99 • n=22 Participants
Sex: Female, Male
Female
53 Participants
n=11 Participants
50 Participants
n=11 Participants
103 Participants
n=22 Participants
Sex: Female, Male
Male
71 Participants
n=11 Participants
80 Participants
n=11 Participants
151 Participants
n=22 Participants
Race/Ethnicity, Customized
Hispanic
64 Participants
n=11 Participants
60 Participants
n=11 Participants
124 Participants
n=22 Participants
Race/Ethnicity, Customized
Black
26 Participants
n=11 Participants
36 Participants
n=11 Participants
62 Participants
n=22 Participants
Race/Ethnicity, Customized
Non-Hispanic white
12 Participants
n=11 Participants
17 Participants
n=11 Participants
29 Participants
n=22 Participants
Race/Ethnicity, Customized
Other
22 Participants
n=11 Participants
17 Participants
n=11 Participants
39 Participants
n=22 Participants
Region of Enrollment
United States
124 participants
n=11 Participants
130 participants
n=11 Participants
254 participants
n=22 Participants

PRIMARY outcome

Timeframe: end of study(about 24 months)

Outcome measures

Outcome measures
Measure
Comprehensive Care (CC) Program
n=124 Participants
Comprehensive care (CC) program: To promote prompt effective care for medically complex children at all hours, the investigators developed an outpatient comprehensive care (CC) program at the University of Texas Health Science Center at Houston, which includes 1) a clinic component with both specialist and primary care in the same clinic, 24/7 direct cell phone access to PCPs at all hours, same weekday care for acute illnesses, and a high staff-to-patient-ratio; 2) a hospital component with consultation service provided by PCPs to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge planning; and 3) a conventional telemedicine (CTM) program during regular clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct appropriate follow-up visits.
Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM)
n=130 Participants
To promote care for medically complex children, investigators developed an outpatient CC program, with: a clinic component with both specialist \& primary care, 24/7 direct phone access to PCPs, same weekday care for acute illnesses, and a high staff-to-patient-ratio; a hospital component with PCP consultations to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge; and a conventional telemedicine program during clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct follow-ups. An enhanced telemedicine program (mobile TytoCare exam kit device) will be added 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 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 primary care physician (PCP), and if needed, any of 10 specialists. A social worker, nutritionist, or psychologist will be involved as needed. Each PCP will perform 2-3 virtual rounds weekly to 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, ED visits, or hospitalizations.
Number of Days Care Provided in a Medical Setting
23.3 days
Interval 0.0 to 62.0
25.9 days
Interval 0.0 to 111.0

PRIMARY outcome

Timeframe: end of study(about 24 months)

Outcome measures

Outcome measures
Measure
Comprehensive Care (CC) Program
n=124 Participants
Comprehensive care (CC) program: To promote prompt effective care for medically complex children at all hours, the investigators developed an outpatient comprehensive care (CC) program at the University of Texas Health Science Center at Houston, which includes 1) a clinic component with both specialist and primary care in the same clinic, 24/7 direct cell phone access to PCPs at all hours, same weekday care for acute illnesses, and a high staff-to-patient-ratio; 2) a hospital component with consultation service provided by PCPs to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge planning; and 3) a conventional telemedicine (CTM) program during regular clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct appropriate follow-up visits.
Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM)
n=130 Participants
To promote care for medically complex children, investigators developed an outpatient CC program, with: a clinic component with both specialist \& primary care, 24/7 direct phone access to PCPs, same weekday care for acute illnesses, and a high staff-to-patient-ratio; a hospital component with PCP consultations to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge; and a conventional telemedicine program during clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct follow-ups. An enhanced telemedicine program (mobile TytoCare exam kit device) will be added 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 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 primary care physician (PCP), and if needed, any of 10 specialists. A social worker, nutritionist, or psychologist will be involved as needed. Each PCP will perform 2-3 virtual rounds weekly to 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, ED visits, or hospitalizations.
Total Number of Episodes of Serious Illnesses (Causing Death, Pediatric ICU Admission, and Hospital Stay > 7d).
41 number of episodes
118 number of episodes

SECONDARY outcome

Timeframe: end of study(about 24 months)

Population: Data were not collected or analyzed for this outcome because cost data could not be obtained from the hospital and no cost information was available for participants. The study protocol was not amended to reflect this collective team decision. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: end of study(about 24 months)

Outcome measures

Outcome measures
Measure
Comprehensive Care (CC) Program
n=124 Participants
Comprehensive care (CC) program: To promote prompt effective care for medically complex children at all hours, the investigators developed an outpatient comprehensive care (CC) program at the University of Texas Health Science Center at Houston, which includes 1) a clinic component with both specialist and primary care in the same clinic, 24/7 direct cell phone access to PCPs at all hours, same weekday care for acute illnesses, and a high staff-to-patient-ratio; 2) a hospital component with consultation service provided by PCPs to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge planning; and 3) a conventional telemedicine (CTM) program during regular clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct appropriate follow-up visits.
Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM)
n=130 Participants
To promote care for medically complex children, investigators developed an outpatient CC program, with: a clinic component with both specialist \& primary care, 24/7 direct phone access to PCPs, same weekday care for acute illnesses, and a high staff-to-patient-ratio; a hospital component with PCP consultations to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge; and a conventional telemedicine program during clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct follow-ups. An enhanced telemedicine program (mobile TytoCare exam kit device) will be added 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 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 primary care physician (PCP), and if needed, any of 10 specialists. A social worker, nutritionist, or psychologist will be involved as needed. Each PCP will perform 2-3 virtual rounds weekly to 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, ED visits, or hospitalizations.
Number of Hospital Admissions Due to All-Cause Infections
2.431 hospital admissions
Interval 0.0 to 51.0
2.453 hospital admissions
Interval 0.0 to 53.0

SECONDARY outcome

Timeframe: end of study(about 24 months)

Outcome measures

Outcome measures
Measure
Comprehensive Care (CC) Program
n=124 Participants
Comprehensive care (CC) program: To promote prompt effective care for medically complex children at all hours, the investigators developed an outpatient comprehensive care (CC) program at the University of Texas Health Science Center at Houston, which includes 1) a clinic component with both specialist and primary care in the same clinic, 24/7 direct cell phone access to PCPs at all hours, same weekday care for acute illnesses, and a high staff-to-patient-ratio; 2) a hospital component with consultation service provided by PCPs to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge planning; and 3) a conventional telemedicine (CTM) program during regular clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct appropriate follow-up visits.
Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM)
n=130 Participants
To promote care for medically complex children, investigators developed an outpatient CC program, with: a clinic component with both specialist \& primary care, 24/7 direct phone access to PCPs, same weekday care for acute illnesses, and a high staff-to-patient-ratio; a hospital component with PCP consultations to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge; and a conventional telemedicine program during clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct follow-ups. An enhanced telemedicine program (mobile TytoCare exam kit device) will be added 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 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 primary care physician (PCP), and if needed, any of 10 specialists. A social worker, nutritionist, or psychologist will be involved as needed. Each PCP will perform 2-3 virtual rounds weekly to 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, ED visits, or hospitalizations.
Average Numbers of Clinic Visits
6.89 clinic visits
Interval 1.0 to 51.0
7.15 clinic visits
Interval 1.0 to 40.0

SECONDARY outcome

Timeframe: end of study(about 24 months)

Outcome measures

Outcome measures
Measure
Comprehensive Care (CC) Program
n=124 Participants
Comprehensive care (CC) program: To promote prompt effective care for medically complex children at all hours, the investigators developed an outpatient comprehensive care (CC) program at the University of Texas Health Science Center at Houston, which includes 1) a clinic component with both specialist and primary care in the same clinic, 24/7 direct cell phone access to PCPs at all hours, same weekday care for acute illnesses, and a high staff-to-patient-ratio; 2) a hospital component with consultation service provided by PCPs to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge planning; and 3) a conventional telemedicine (CTM) program during regular clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct appropriate follow-up visits.
Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM)
n=130 Participants
To promote care for medically complex children, investigators developed an outpatient CC program, with: a clinic component with both specialist \& primary care, 24/7 direct phone access to PCPs, same weekday care for acute illnesses, and a high staff-to-patient-ratio; a hospital component with PCP consultations to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge; and a conventional telemedicine program during clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct follow-ups. An enhanced telemedicine program (mobile TytoCare exam kit device) will be added 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 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 primary care physician (PCP), and if needed, any of 10 specialists. A social worker, nutritionist, or psychologist will be involved as needed. Each PCP will perform 2-3 virtual rounds weekly to 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, ED visits, or hospitalizations.
Average Total Number of Emergency Department Visits
2.28 emergency department visit
Interval 0.0 to 23.0
2.8 emergency department visit
Interval 0.0 to 23.0

SECONDARY outcome

Timeframe: end of study(about 24 months)

Outcome measures

Outcome measures
Measure
Comprehensive Care (CC) Program
n=124 Participants
Comprehensive care (CC) program: To promote prompt effective care for medically complex children at all hours, the investigators developed an outpatient comprehensive care (CC) program at the University of Texas Health Science Center at Houston, which includes 1) a clinic component with both specialist and primary care in the same clinic, 24/7 direct cell phone access to PCPs at all hours, same weekday care for acute illnesses, and a high staff-to-patient-ratio; 2) a hospital component with consultation service provided by PCPs to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge planning; and 3) a conventional telemedicine (CTM) program during regular clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct appropriate follow-up visits.
Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM)
n=130 Participants
To promote care for medically complex children, investigators developed an outpatient CC program, with: a clinic component with both specialist \& primary care, 24/7 direct phone access to PCPs, same weekday care for acute illnesses, and a high staff-to-patient-ratio; a hospital component with PCP consultations to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge; and a conventional telemedicine program during clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct follow-ups. An enhanced telemedicine program (mobile TytoCare exam kit device) will be added 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 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 primary care physician (PCP), and if needed, any of 10 specialists. A social worker, nutritionist, or psychologist will be involved as needed. Each PCP will perform 2-3 virtual rounds weekly to 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, ED visits, or hospitalizations.
Average Number of Hospital Days
14.79 days
Interval 0.0 to 62.0
16.34 days
Interval 0.0 to 110.0

SECONDARY outcome

Timeframe: end of study(about 24 months)

Outcome measures

Outcome measures
Measure
Comprehensive Care (CC) Program
n=124 Participants
Comprehensive care (CC) program: To promote prompt effective care for medically complex children at all hours, the investigators developed an outpatient comprehensive care (CC) program at the University of Texas Health Science Center at Houston, which includes 1) a clinic component with both specialist and primary care in the same clinic, 24/7 direct cell phone access to PCPs at all hours, same weekday care for acute illnesses, and a high staff-to-patient-ratio; 2) a hospital component with consultation service provided by PCPs to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge planning; and 3) a conventional telemedicine (CTM) program during regular clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct appropriate follow-up visits.
Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM)
n=130 Participants
To promote care for medically complex children, investigators developed an outpatient CC program, with: a clinic component with both specialist \& primary care, 24/7 direct phone access to PCPs, same weekday care for acute illnesses, and a high staff-to-patient-ratio; a hospital component with PCP consultations to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge; and a conventional telemedicine program during clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct follow-ups. An enhanced telemedicine program (mobile TytoCare exam kit device) will be added 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 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 primary care physician (PCP), and if needed, any of 10 specialists. A social worker, nutritionist, or psychologist will be involved as needed. Each PCP will perform 2-3 virtual rounds weekly to 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, ED visits, or hospitalizations.
Average Number of Pediatric Intensive Care Unit (PICU) Days
5.169 days
Interval 0.0 to 61.0
8.362 days
Interval 0.0 to 88.0

SECONDARY outcome

Timeframe: end of study(about 24 months)

Outcome measures

Outcome measures
Measure
Comprehensive Care (CC) Program
n=124 Participants
Comprehensive care (CC) program: To promote prompt effective care for medically complex children at all hours, the investigators developed an outpatient comprehensive care (CC) program at the University of Texas Health Science Center at Houston, which includes 1) a clinic component with both specialist and primary care in the same clinic, 24/7 direct cell phone access to PCPs at all hours, same weekday care for acute illnesses, and a high staff-to-patient-ratio; 2) a hospital component with consultation service provided by PCPs to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge planning; and 3) a conventional telemedicine (CTM) program during regular clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct appropriate follow-up visits.
Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM)
n=130 Participants
To promote care for medically complex children, investigators developed an outpatient CC program, with: a clinic component with both specialist \& primary care, 24/7 direct phone access to PCPs, same weekday care for acute illnesses, and a high staff-to-patient-ratio; a hospital component with PCP consultations to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge; and a conventional telemedicine program during clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct follow-ups. An enhanced telemedicine program (mobile TytoCare exam kit device) will be added 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 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 primary care physician (PCP), and if needed, any of 10 specialists. A social worker, nutritionist, or psychologist will be involved as needed. Each PCP will perform 2-3 virtual rounds weekly to 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, ED visits, or hospitalizations.
Total Number of Deaths
3 Participants
6 Participants

SECONDARY outcome

Timeframe: end of study(about 24 months)

Population: Data were not collected for this outcome measure because the study survey was not administered. Therefore, no data were available for any participants. This outcome measure will not be collected in the future. The study protocol was not amended to reflect this.

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.

Outcome measures

Outcome data not reported

Adverse Events

Comprehensive Care (CC) Program

Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths

Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ricardo A Mosquera, MD

The University of Texas Health Science Center at Houston

Phone: 713-500-5650

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place