Evaluating the Value of Telehealth for Care of Children With Medical Complexity
Phase: NA
Conditions: Cerebral Palsy
Sponsor: Wake Forest University Health Sciences

Evaluating the Value of Telehealth for Care of Children With Medical Complexity 
Clinicaltrials.gov Identifier: NCT02849938 
Unique Protocol ID: CCCMCTeleMed 
 
 
Study Protocol and Statistical Analysis Plan 
Last Revised: September 29, 2016 
Participants 
This study was designed as a single center, randomized, non-blinded pilot study. Sample 
size was determined by number of eligible patients enrolled in the Coordinated Care for 
Children with Medical Complexity (CCCMC) program at our institution as well as 
number of devices that were available for the pilot.  Inclusion criteria included: patients 
aged 1 month to 18 years, currently enrolled in the CCCMC program; parent consent; at 
least one English-speaking parent; and in-home Wi-Fi connectivity. Children enrolled in 
the CCCMC program met the following criteria: 3 or more body systems requiring active 
management; technology dependent or full support to complete activities of daily living; 
and moderate or severe neuromotor delays, or intellectual disability. Children were 
excluded from this pilot study if caregivers expressed an inability to comply with study 
requirements. Participants were randomized 1.5:1 with stratification based on 
tracheostomy status to control group or intervention group (Research Randomizer, 
Urbaniak). This stratification was done to attempt to balance patient contact between the 
groups based on the assumption that patients with tracheostomies may require more 
frequent contact with the CCCMC team. Clinicians in the CCCMC program included a 
pediatrician and pediatric nurse practitioner. This study and subsequent revision was 
approved by the Advocate Health Care Institutional Review Board and registered at 
ClinicalTrials.gov (Identifier: NCT02849938). 

Telehealth Device 
The selected telehealth device (TytoHomeTM) is an FDA-approved, handheld, mobile 
device designed for capture and transmission of ear, throat, and skin images, heart and 
lung auscultations including heart rate detection, and temperature data taken by infrared 
transdermal thermometer.  The device required pairing with an iOS tablet (Apple iPad 
mini 4) for transmission via wireless network for live-interactive clinician connection. 
Caregivers used the telehealth device to perform non-invasive medical examinations in 
the home for remote view by a clinician. TytoCareTM provided the telehealth devices and 
the iPad minis that were used in the pilot. 
Procedure 
Enrolled parent caregivers provided informed consent during a home visit for study 
initiation. For those in the intervention group, members of the TytoCareTM team were 
present along with study team to explain the use of the telehealth device and iPad mini; 
set up the components and connect them to in-home Wi-Fi; and answer any questions.  
The home was assessed for adequate internet connectivity and supplemental connectivity 
was provided by TytoCareTM if needed.  
All caregivers were instructed to contact their clinician by telephone or email as usual 
when they had any health concerns. If an exam was deemed necessary by the clinician, 
patients in the control group were referred for an in person encounter, whereas caregivers 
of patients in the intervention group were directed to connect the telehealth device if 
appropriate. During a telehealth visit, the clinician conducted a 2-way, live, interactive 

audio/video visit with the patient. If clinically indicated the clinician would direct the 
caregiver to use the telehealth device to provide temperature, lung sounds, heart sounds, 
oropharyngeal exam, skin exam and/or ear exam. Regardless of the group, the clinician 
would base direction for necessary treatment, referral to an ED, clinic visit or 
hospitalization based on available data. In addition, telehealth visits were scheduled in 
advance for routine care if indicated such as for post-discharge care, follow-up for a 
particular concern, or to maintain familiarity with the telehealth device (technical 
practice).  
Data Collection 
The length of the study observation period was increased from 3 to 4 months due to 
technology issues that were encountered and managed during the first month of the study 
(termed “technical month”). Data collection included subject demographics, encounter 
details (outpatient clinic visits, ED visits, and hospitalizations) that were routinely 
collected as a part of the CCCMC program, as well as caregiver and clinician surveys, 
which used a 4-point Likert response scale.  All caregivers answered questions about 
CCCMC program satisfaction, and those in the intervention group answered additional 
questions about their comfort using the device. Caregivers were emailed a link to the 
online survey once a month during the study period.  Surveys not completed online were 
conducted over the phone by a member of the study team who did not participate in 
patient care. Clinicians completed an online survey for each encounter in which they 
would have liked to complete a telemedicine visit regardless of child’s group assignment. 
They answered general satisfaction questions as well as demographic, feasibility, and 

usability questions. Questions on the feasibility and usability of the telehealth device 
addressed the success of device connectivity, as well as the transmission of real-time 
images, temperature, and sound. Other questions asked about potential or actual changes 
in patient management because of the telehealth device. Specific measures to address 
each study outcome can be found in Table 1. 
Analysis 
Descriptive statistics were used to summarize data with absolute and relative frequencies 
for categorical variables and means and standard deviations (SD) for continuous 
variables. Feasibility and usability of the device as determined from survey responses and 
reported as median and interquartile range (IQR). Continuous variables were examined 
using independent groups Student’s t-test or the Mann-Whitney U test depending upon 
normality of data. Dichotomous variables were examined using Chi-square or Fisher 
exact tests.  Data are reported for the first technical month and subsequent 3-month 
observation period separately.  
The impact of device utilization was evaluated by measuring the total number of visits 
per patient by type (outpatient visits of low, moderate, and high complexity; ED visit 
without subsequent admission, general pediatric ward days, pediatric intensive care unit 
days) as determined via chart review. To adjust for the difference in sample size per 
group, the number of hospitalization days, acute office visits, and ED visits were reported 
descriptively as a visit rate calculated as the number of visits or hospital days/patient 
study months (number of patients in the group x number of study months). Four months 
of data were used for the calculation because the control group did not have any 

hospitalizations during the technical month. The Kaplan-Meier method was used to 
estimate the proportion of each group that did not have any hospitalizations during the 
study period.  A statistical comparison of the survival distribution was not conducted 
because the Kaplan-Meier method does not account for repeated episodes such as patients 
with more than one hospitalization. 
A negative binomial regression model with Generalized Estimating Equations to handle 
repeated measurements was used to test the difference in hospital length of stay between 
groups. Model results were reported as regression coefficients, 95% Wald confidence 
intervals and p values.  The negative binomial regression model was appropriate for this 
analysis, as the distribution of the outcome had greater variability than expected under a 
Poisson distribution. The sample mean of the outcome (4.3) was substantially smaller 
than its variance (102.3).  Regression models were not tested for the number of acute 
office or ED visits because the incidence rate was too small for the inferential statistic. 
Analyses were conducted using SPSS (version 22.0) (IBM Corp. Released 2013. IBM 
SPSS Statistics for Windows, Version 22.0. Armonk, NY: IBM Corp).  For all analyses, a 
p value < 0.05 was considered statistically significant. 
Direct cost for each encounter was obtained from our institution’s financial accounting 
system (EPSi), which was used to calculate direct costs per study group and encounter 
type (not including overhead costs such as cost of the telehealth device or connectivity). 
For the intervention group, a telemedicine visit was equated to a Level 4 return encounter 
in the outpatient setting. Direct cost savings were calculated as the absolute difference 
between the two study groups. To adjust for the difference in group sample size, the 

encounter direct cost was multiplied by the visit rate and the adjusted cost rates were 
described for each group. Potential cost savings were calculated using clinician input on 
the visit types that were likely prevented as a result of the telemedicine device.