Cerebral Palsy Clinical Trial
Official title:
Evaluating the Value of Telehealth for Care of Children With Medical Complexity
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
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.
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