Cerebral Palsy
Conditions
Keywords
children with medical complexity, Telemedicine, Tracheostomy
Brief summary
The specific aims of the study are to: 1. Assess the feasibility of a TytoCare telehealth device with remote audio/video connection for evaluation of children with medical complexity in the home environment. 2. Evaluate the usability of a TytoCare telehealth device in transmitting real time images (otoscope, oropharyngeal exam, camera), temperature, and sound (stethoscope for heart and breath sounds) 3. Compare the impact of the TytoCare telehealth device versus traditional telephone assessment on patient management and user satisfaction
Detailed description
Eligible children of interested parent(s) will be randomly assigned to either the control group (standard care) or the intervention group (Tyto device). Randomization will be performed using an online randomization program to generate group assignments for the 25 subjects. Subjects will be stratified by whether they have a tracheostomy or not and be assigned 1.5:1 to achieve 15 children in the device group and 10 children in the control group. Informed consent will be obtained for children in each group. Children/families in the control group will continue to get usual care through the CCCMC program, and will be able to access their providers via telephone for urgent care needs and scheduled follow up. For evaluation purposes, data collection will include the monthly encounter tracking that is done routinely as part of the CCCMC program, and research surveys completed by both parents and HCPs. Parents will complete a Parent Survey by phone once each month for the 3-month study period. The CCCMC HCPs will complete the Provider Survey electronic survey with each telephone encounter where the HCP would have liked to use the device. For those assigned to the device group, parents will be instructed to contact their CCCMC HCP as usual, see bullet points above, when health concerns arise and their HCP will decide if she would like a telehealth visit. Telehealth/video visits may also be scheduled in advance as a matter of routine follow-up care. In the event that an exam is deemed necessary by the HCP, the parent or caregiver will be directed to connect via the remote exam device. The provider will conduct a 2-way live interactive audio/video visit with the patient. The parent or caregiver will use the remote exam device to provide temperature, lung sounds, heart sounds, oropharyngeal exam, skin exam and/or ear exam as clinically indicated. Direction for necessary treatment, referral to an ED, clinic or inpatient care will be at the discretion of the CCCMC provider. For evaluation purposes, in addition to the monthly encounter tracking that is done as part of the CCCMC program, both parents and HCPs will complete surveys. Parents will complete a Parent Survey by phone once each month for the 3-month study period. The CCCMC HCPs will complete the Provider Survey via a Qualtrics link with each telehealth encounter. Additional data collected will include subject demographics, and encounter data that is routinely collected as a part of the CCCMC program. Images of patient encounters will be transmitted in real time via the telemedicine device encrypted software. Provider Survey data will be gathered via Qualtrics. Tyto will retain / store data obtained from device group encounters in a de-identified way for development purposes only.
Interventions
DEVICETytoCare 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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patient aged 1 month to 18 years * Patient currently enrolled in CCCMC program at ACH-OL * Parental permission/consent * English-speaking (at least one parent) * Internet connected home wi-fi
Exclusion criteria
* Unable to comply with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of In-person Health Care Encounters | 3 months | Hospital day length of stay reported as the total number of hospital days in the group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Provider Survey | 3 months | Success of connection for telemedicine visits. |
| Parent Survey | 3 months | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 15 |
| Total | 24 |
Baseline characteristics
| Characteristic | Telemedicine Group | Total | Control Group |
|---|---|---|---|
| Age, Categorical <=18 years | 15 Participants | 24 Participants | 9 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.81 years STANDARD_DEVIATION 5.74 | 9.01 years STANDARD_DEVIATION 6.02 | 9.32 years STANDARD_DEVIATION 6.67 |
| Number of medical diagnoses active at enrollment | 10 diagnoses STANDARD_DEVIATION 3.4 | 10 diagnoses STANDARD_DEVIATION 3.57 | 11 diagnoses STANDARD_DEVIATION 3.71 |
| Number of specialists involved in the care of the patient | 5.87 specialists STANDARD_DEVIATION 1.51 | 5.67 specialists STANDARD_DEVIATION 1.69 | 5.55 specialists STANDARD_DEVIATION 1.87 |
| Race/Ethnicity, Customized Non-white | 7 Participants | 14 Participants | 7 Participants |
| Region of Enrollment United States | 15 participants | 24 participants | 9 participants |
| Sex: Female, Male Female | 7 Participants | 13 Participants | 6 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 3 Participants |
| Trach: present | 7 Participants | 11 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 15 |
| other Total, other adverse events | 0 / 9 | 0 / 15 |
| serious Total, serious adverse events | 0 / 9 | 0 / 15 |
Outcome results
Primary
Frequency of In-person Health Care Encounters
Hospital day length of stay reported as the total number of hospital days in the group.
Time frame: 3 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Frequency of In-person Health Care Encounters | Hospitalization days - floor | 24 days |
| Control Group | Frequency of In-person Health Care Encounters | Hospitalization days - ICU | 41 days |
| Telemedicine Group | Frequency of In-person Health Care Encounters | Hospitalization days - floor | 19 days |
| Telemedicine Group | Frequency of In-person Health Care Encounters | Hospitalization days - ICU | 46 days |
Secondary
Parent Survey
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
Time frame: 3 months
Population: Control group participants did not answer questions regarding the tele health device in the satisfaction survey as they did not have access to this.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control Group | Parent Survey | Interaction with clinicians | 4 units on a scale |
| Control Group | Parent Survey | Complex care program satisfaction | 4 units on a scale |
| Telemedicine Group | Parent Survey | Satisfaction with telehealth device | 4 units on a scale |
| Telemedicine Group | Parent Survey | Comfortable with telehealth device | 4 units on a scale |
| Telemedicine Group | Parent Survey | Interaction with clinicians | 4 units on a scale |
| Telemedicine Group | Parent Survey | Complex care program satisfaction | 4 units on a scale |
Secondary
Provider Survey
Success of connection for telemedicine visits.
Time frame: 3 months
Population: Control group participants did not have data for telemedicine device use as they did not have access to this.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Telemedicine Group | Provider Survey | Connection worked great for telemedicine visit | 37 Visit Connections |
| Telemedicine Group | Provider Survey | Connection was problematic for telemedicine visit | 9 Visit Connections |
| Telemedicine Group | Provider Survey | Not able to get connection with telemedicine visit | 4 Visit Connections |