Evaluating the Value of Telehealth for Care of Children With Medical Complexity
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

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.
    

Intervention name(s): TytoCare Device
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: children with medical complexity; Telemedicine; Tracheostomy