An Integrated Telemedicine-Home Visitation Program to Increase Outcomes for Children With Medical Complexity

Background Children with medical complexity (CMC) have one or more chronic illnesses, require
treatment from multiple specialists, and often depend on medical technology for respiratory
and nutritional support.6 Their care is fragmented, ineffective, and inefficient,2,7 and
while they represent only 0.4% of all children in the US, they account for approximately 40%
of pediatric deaths and hospital charges.6

Optimizing their outcomes is likely to require a comprehensive approach to their care in all
settings: clinic, hospital, and home. The investigators have developed effective programs for
their clinic and hospital care and now propose to add an innovative program to improve care
in the home and verify its incremental cost effectiveness.

The clinic component is provided in the High-Risk Children's Clinic (HRCC), an enhanced
medial home for CMC staffed by a highly experienced team of nurse practitioners,
pediatricians, and pediatric subspecialists. The multiple features to promote prompt
effective care at all hours include 24/7 cell-phone access to the PCPs. As shown in the prior
randomized trial (funded by a CMS Health Care Innovation Award), this program reduced ED
visits, hospital days, and ICU days by 47-69%, and health system costs by $10,258 per
child-year below that with usual care. This trial was published in JAMA,2 highlighted by CMS,
and attracted national attention as the most rigorous evidence to date supporting medical
homes for patient group.8,9 The remarkable cost effectiveness of this program was found in
later cohort analyses to have been well maintained or enhanced when the program was expanded
to include all eligible CMC, including prior control children and new enrollees.3

The hospital component is an inpatient consultation service in which the HRCC staff consult
and follow their patients admitted to Children's Memorial Hermann Hospital (CMHH) to make
treatment recommendations, coordinate care, and plan their discharge. The investigators
randomized half of HRCC patients to receive this service in pilot testing. Results indicate a
major reduction in inpatient days for patients given the service vs. those not given the
service: 289 vs. 615 total hospital days/100 child-years with a 95% (posterior) probability
of reduced hospital days in Bayesian analysis (rate ratio [RR], 0.62 [0.36, 1.09]). Having
improved both inpatient and outpatient care, the investigators now propose to develop and
rigorously assess a novel integrated telemedicine-home-visitation program (THVP) to also
augment care for CMC in their home. The investigators will test the program in a clinical
trial to verify its effectiveness and cost-effectiveness in reducing total days of care
outside the home and to augment clinical practice and health policy.

Rationale and Evidence Base

As emphasized by Hoffman and Emanuel10:

"Clinicians need to abandon their long-established approach of caring for patients in the
hospital or the office…Patients spend most of their time away from the health care system and
the focus has to be one of managing their health literally where they live with much more
wireless monitoring, electronic and phone visits, at-home care, and patient engagement."

Reducing the need for care outside the home is likely to be especially beneficial for CMC;
>90% are Medicaid beneficiaries. Their parents have limited resources and many find it
difficult or costly to miss work and travel to Texas Medical Center. Moreover, any time spent
in a medical setting imposes a risk of acquiring serious, even life-threating infections for
CMC.

A systematic review by AHRQ in 201611 reported that: 1) telemedicine promotes positive
outcomes for chronically ill adults but has received little study for CMC, and 2) research to
identify cost-effective models of telehealth deserves high priority.

Home visits have been widely recommended to improve care and reduce clinic visits and
hospitalizations.12-15 However, systematic reviews of home visitation have emphasized the
need for further study, particularly for socially high-risk children.13

To maximize the potential benefits, the investigators will provide both interventions in an
integrated program. The investigators will randomize the CMC in the HRCC to receive either
the usual complex care (UCC [including comprehensive outpatient care and inpatient
consultation] or THVP (UCC plus this telemedicine-home-visitation program)

Study Hypotheses

Primary Hypothesis: THVP will reduce days of care outside the home (in the hospital, ED, or
clinic [excluding well-child checks]).

Secondary Hypotheses:

1. THVP will reduce the rate of serious illness (death, PICU admission, or prolonged
hospitalization >7 days);

2. THVP will reduce the total number of ER visits;

3. THVP will reduce the total number of admissions;

4. THVP will reduce the total number of PICU admission

5. THVP will reduce the total number of readmissions within 30 days of discharge;

6. THVP will reduce health system costs;

7. THVP will not reduce the total number of well-child checks;

8. THVP will increase maternal rating on pre-selected questions of The Consumer Assessment
of Healthcare Providers and Systems (CAHPS) Child 12-Month Survey;

Methods

Enrollment and Randomization: The UTH institutional review board has reviewed this study and
determined that it does not qualify as human subject research. As a result, the study was
registered within the UTH QI Project database. Partly because of differences in the number of
routine visits, all eligible CMC will be stratified by age (< 2 years or older), and by
estimated baseline risk (risk level 1 [mechanical ventilation], risk level 2 [equal to or
above the expected median risk but not ventilator-dependent], and risk level 3 [below the
expected median risk]), as judged by the clinic's medical director [R. Mosquera] based on
patient's diagnoses, prior clinical course, current medical status, and socioeconomic risk
factors. Patients will be randomized to either THVP or UCC using a computer-generated
algorithm in REDCap with variable block sizes. Randomization will occur at baseline for the
existing HRCC patients, before hospital discharge for newly enrolled patients with chronic
respiratory failure requiring mechanical ventilation at home, and during the first clinic
visit for any eligible new non-ventilator dependent children. Patient enrollment will occur
between July 2018 and June 2020.

Integrated Telemedicine-Home-Visitation Program

The program is based on: 1) published findings of telemedicine or home visits in chronically
ill children with diabetes, hemophilia, or leukemia;5,13-15 2) the collaboration with Drs.
Harting and Mary Austin in successfully using telemedicine for postoperative follow-up visits
for approximately 40 children in the past 14 months; 3) consultation from IT personnel at
both MHH (Brian Thyer, Lead Programmer Analyst), and UTH (Andrew Streckfuss, MBA, Manager of
IT Projects and Research) who have setup Zoom platform at UTH. In refining the program during
the project, the investigators expect to interact with centers advancing telemedicine use for
children with asthma, diabetes, hemophilia, or leukemia.4,5

Planned Telemedicine Features: The investigators will use the Zoom platform for telemedicine.
Because the clinic is already equipped with a smart television, web cameras, and an emergency
IPhone, no additional equipment will be required. With the help of HRCC staff, the families
randomized to THVP will download a free Zoom application to any Android or iPhone, which
almost all the patients already have. Telemedicine will be utilized systematically following
calls received by the PCPs during clinic hours from parents seeking medical advice or trying
to schedule same-day appointments for their sick child and only when considered likely to be
beneficial for phone calls to the HRCC cell phone on weeknights and weekends. It will also be
used for scheduled follow-up appointments as judged needed by the PCPs.

Home Visitation Features: Home visits will be conducted by a nurse home visitor when
considered likely to be beneficial for any of the CMC and at least once by the assigned PCP
shortly after discharge home from the hospital following enrollment of a ventilator-dependent
child. Visits will be scheduled at a time convenient for the family. When needed for clinical
or safety concerns, the nurse visitor or the PCP will be joined by a respiratory therapist,
dietician, social worker, or medical assistant. Home visits will not be conducted whenever
the visitor(s) feel unsafe. In these circumstances, the investigators will rely instead on
telemedicine.

Blinding: While the families and HRCC staff cannot be blinded, the healthcare economist and
the statistician will remain blinded to treatment group when performing the analyses.

Economic Evaluation and Statistical Analyses: The incremental costs of THVP vs. UCC will be
assessed from a health system perspective. Inpatient costs will be based on hospital charges
multiplied by MHH department-specific cost-to-charge ratios. The personnel time for providing
office visits at the HRCC will be assessed by time motion studies and will be multiplied by
personnel unit costs and the observed number of HRCC visits occurring in each treatment group
during the study. The personnel time cost devoted to providing inpatient consultation will be
assessed by multiplying the mean time spent on hospital consultations by the number of
hospital days at CMHH occurring in each treatment group and by personnel unit costs. For the
THVP group, the investigators will add the time spent providing telemedicine consultation by
tabulating data on overall Zoom usage and multiplying it by personnel unit costs. THVP costs
will also be augmented by the monthly fees for the Zoom licenses, and the HRCC staff time
spent assisting patients with Zoom App installation and use. The remaining clinic costs for
compressive care will be estimated based on the HRCC's total expenditures (including
personnel salary, benefits, and overhead costs) and will be allocated to patients based on
each patient length of follow-up during the study.

All economic and statistical analyses will be conducted using multilevel generalized
estimating equation (GEE) models. Number of days of care in a medical setting in the THVP and
UCC groups will be compared using a negative binomial GEE model with log link. Differences in
costs between treatment groups will be assessed using a GEE model with log-link and gamma
distribution. All the models will be adjusted for age (< 2 years or older), baseline risk
(risk levels 1,2, or 3), within-family correlation, length of follow-up, and any important
differences in treatment with inpatient consultation.

The investigators will perform Bayesian analyses to assess the effectiveness of the THVP in
reducing treatment days outside the home relative to UCC (primary outcome) using a neutral
prior probability. Given the favorable prior evidence of benefit from THVP in other
conditions,4,11 a skeptical prior is considered unnecessary. Based on the current number of
patients and enrollment rates in the HRCC, the investigators expect to randomize ~400
patients during the 2-year study for a total of ~800 child-years of follow-up. THVP will be
considered beneficial if: a) Bayesian analyses indicate it has a >70% probability of reducing
treatment days outside the home; and b) there is no evidence of an increase in adverse
secondary outcomes. If so, provision of THVP could be recommended simply to increase access
to care for vulnerable, disadvantaged children.

Inclusion Criteria:

- Children attending the High-Risk Children's Clinic

- 1 or more chronic conditions

- High healthcare utilization in the year prior to enrollment (of ≥3 ED visits, ≥2
hospitalizations, or ≥1 pediatric ICU admissions)

- >50% estimated risk of hospitalization in the year after enrollment (as judged by
Program's Director [Dr. R. Mosquera] based on patient's diagnosis, clinical course,
and socioeconomic risk factor).

Exclusion Criteria:

- Unrepaired congenital heart disease

- Mitochondrial disorders

- Active cancer

- Do-Not-Resuscitate (DNR) order

- Patients receiving compassionate care

- No Internet access