Trial Outcomes & Findings for Evaluating the Value of Telehealth for Care of Children With Medical Complexity (NCT NCT02849938)
NCT ID: NCT02849938
Last Updated: 2024-10-08
Results Overview
Hospital day length of stay reported as the total number of hospital days in the group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
3 months
Results posted on
2024-10-08
Participant Flow
Participant milestones
| Measure |
Control Group
Received usual care through the pediatric complex care program at our institution. This included 24/7 availability by the program clinicians for phone calls and electronic message from caregivers. The clinicians provided primary care and consultative services focusing on outpatient comprehensive care visits. The team also provided inpatient consultation.
|
Telemedicine Group
Received the TytoCare Device in addition to usual care.
TytoCare Device: Tyto is a handheld, mobile device designed for capture and transmission of ear/throat/skin images and lung/heart auscultations. It may be used to perform non-invasive, medical examinations, either on a patient (by another person, most commonly a family member, or by a medical professional) or self-performed by the patient, for remote review by a medical practitioner. It is suitable for use on patients in both clinical and home environment.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
15
|
|
Overall Study
COMPLETED
|
9
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Value of Telehealth for Care of Children With Medical Complexity
Baseline characteristics by cohort
| Measure |
Control Group
n=9 Participants
Received usual care through the pediatric complex care program at our institution. This included 24/7 availability by the program clinicians for phone calls and electronic message from caregivers. The clinicians provided primary care and consultative services focusing on outpatient comprehensive care visits. The team also provided inpatient consultation.
|
Telemedicine Group
n=15 Participants
Received the TytoCare Device in addition to usual care.
TytoCare Device: Tyto is a handheld, mobile device designed for capture and transmission of ear/throat/skin images and lung/heart auscultations. It may be used to perform non-invasive, medical examinations, either on a patient (by another person, most commonly a family member, or by a medical professional) or self-performed by the patient, for remote review by a medical practitioner. It is suitable for use on patients in both clinical and home environment.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
9.32 years
STANDARD_DEVIATION 6.67 • n=5 Participants
|
8.81 years
STANDARD_DEVIATION 5.74 • n=7 Participants
|
9.01 years
STANDARD_DEVIATION 6.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-white
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
15 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Number of specialists involved in the care of the patient
|
5.55 specialists
STANDARD_DEVIATION 1.87 • n=5 Participants
|
5.87 specialists
STANDARD_DEVIATION 1.51 • n=7 Participants
|
5.67 specialists
STANDARD_DEVIATION 1.69 • n=5 Participants
|
|
Trach: present
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Number of medical diagnoses active at enrollment
|
11 diagnoses
STANDARD_DEVIATION 3.71 • n=5 Participants
|
10 diagnoses
STANDARD_DEVIATION 3.40 • n=7 Participants
|
10 diagnoses
STANDARD_DEVIATION 3.57 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsHospital day length of stay reported as the total number of hospital days in the group.
Outcome measures
| Measure |
Control Group
n=9 Participants
Received usual care through the pediatric complex care program at our institution. This included 24/7 availability by the program clinicians for phone calls and electronic message from caregivers. The clinicians provided primary care and consultative services focusing on outpatient comprehensive care visits. The team also provided inpatient consultation.
|
Telemedicine Group
n=15 Participants
Received the TytoCare Device in addition to usual care.
TytoCare Device: Tyto is a handheld, mobile device designed for capture and transmission of ear/throat/skin images and lung/heart auscultations. It may be used to perform non-invasive, medical examinations, either on a patient (by another person, most commonly a family member, or by a medical professional) or self-performed by the patient, for remote review by a medical practitioner. It is suitable for use on patients in both clinical and home environment.
|
|---|---|---|
|
Frequency of In-person Health Care Encounters
Hospitalization days - floor
|
24 days
|
19 days
|
|
Frequency of In-person Health Care Encounters
Hospitalization days - ICU
|
41 days
|
46 days
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Control group participants did not have data for telemedicine device use as they did not have access to this.
Success of connection for telemedicine visits.
Outcome measures
| Measure |
Control Group
Received usual care through the pediatric complex care program at our institution. This included 24/7 availability by the program clinicians for phone calls and electronic message from caregivers. The clinicians provided primary care and consultative services focusing on outpatient comprehensive care visits. The team also provided inpatient consultation.
|
Telemedicine Group
n=50 Visit Connections
Received the TytoCare Device in addition to usual care.
TytoCare Device: Tyto is a handheld, mobile device designed for capture and transmission of ear/throat/skin images and lung/heart auscultations. It may be used to perform non-invasive, medical examinations, either on a patient (by another person, most commonly a family member, or by a medical professional) or self-performed by the patient, for remote review by a medical practitioner. It is suitable for use on patients in both clinical and home environment.
|
|---|---|---|
|
Provider Survey
Connection worked great for telemedicine visit
|
—
|
37 Visit Connections
|
|
Provider Survey
Connection was problematic for telemedicine visit
|
—
|
9 Visit Connections
|
|
Provider Survey
Not able to get connection with telemedicine visit
|
—
|
4 Visit Connections
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Control group participants did not answer questions regarding the tele health device in the satisfaction survey as they did not have access to this.
Overall satisfaction with device, comfort with Device, satisfaction with clinician interactions and development of plans of care; Questions asked using 4 point Likert scale (4 = Very Satisfied , 1=Very Dissatisfied). Higher score more satisfaction
Outcome measures
| Measure |
Control Group
n=9 Participants
Received usual care through the pediatric complex care program at our institution. This included 24/7 availability by the program clinicians for phone calls and electronic message from caregivers. The clinicians provided primary care and consultative services focusing on outpatient comprehensive care visits. The team also provided inpatient consultation.
|
Telemedicine Group
n=15 Participants
Received the TytoCare Device in addition to usual care.
TytoCare Device: Tyto is a handheld, mobile device designed for capture and transmission of ear/throat/skin images and lung/heart auscultations. It may be used to perform non-invasive, medical examinations, either on a patient (by another person, most commonly a family member, or by a medical professional) or self-performed by the patient, for remote review by a medical practitioner. It is suitable for use on patients in both clinical and home environment.
|
|---|---|---|
|
Parent Survey
Satisfaction with telehealth device
|
—
|
4 units on a scale
Interval 3.5 to 4.0
|
|
Parent Survey
Comfortable with telehealth device
|
—
|
4 units on a scale
Interval 3.5 to 4.0
|
|
Parent Survey
Interaction with clinicians
|
4 units on a scale
Interval 3.7 to 4.0
|
4 units on a scale
Interval 4.0 to 4.0
|
|
Parent Survey
Complex care program satisfaction
|
4 units on a scale
Interval 3.7 to 4.0
|
4 units on a scale
Interval 4.0 to 4.0
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Telemedicine Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place