Clinical trial NCT02849938: Evaluating the Value of Telehealth for Care of Children With Medical Complexity
Official title: Evaluating the Value of Telehealth for Care of Children With Medical Complexity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: children with medical complexity
Telemedicine
Tracheostomy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of In-person Health Care Encounters
timeFrame: 3 months
Secondary outcomes:
measure: Provider Survey
timeFrame: 3 months
measure: Parent Survey
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Advocate Children's Hospital
name: Patricia M Notario, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Notario PM, Gentile E, Amidon M, Angst D, Lefaiver C, Webster K. Home-Based Telemedicine for Children with Medical Complexity. Telemed J E Health. 2019 Nov;25(11):1123-1132. doi: 10.1089/tmj.2018.0186. Epub 2019 Jan 30.