Home Centered Comprehensive Care (HCCC) for Children With Asthma

BACKGROUND INFORMATION

Asthma is the most common pediatric chronic disease. Despite the understanding of its
pathophysiology and the availability of effective therapies, adverse effects on health,
school attendance, academic achievement, and family life remain high, particularly among
children with severe asthma in minority or low income families.

Innovative new approaches are needed. One innovation that have shown to be cost-effective in
high-risk chronically ill children, including children with severe asthma, is care in an
enhanced medical home, our High-Risk Comprehensive Care (HRCC) which was designed to
optimize care in medical settings. The innovation to be pilot-tested in the proposed
research is Home-Centered Comprehensive Care (HCCC) designed to also optimize care in the
home and thereby reduce clinic visits and school absences and further decrease Emergency
Department visits and hospital days. The proposed HCCC trial builds on the infrastructure,
cell phone access to the child's primary caregivers at any hour, and improved outcomes
established in our previous HRCC trial (clinicaltrials.gov Identifier: NCT02128776.

DESIGN

Pilot trial of 80 children (2-18 years of age) with uncontrolled severe asthma randomized to
either:

- High-Risk Comprehensive Care (HRCC) that includes 24/7 cell phone access to skilled
caregivers, same day care for acute illness Monday through Friday, subspecialty care
available in the same facility, and identification each weekday of all children having
ED visits and hospitalizations to assure prompt follow-up and coordination of care; or

- Home-Centered Comprehensive Care (HCCC) that will also include: 1) monitoring and
augmenting treatment adherence using a special sensor to track inhaler use and identify
inadequate or excessive medication; 2) using a simple hand-held PIKO-1 device to assess
and transmit to caregivers the 1-second forced expiratory volume, allowing caregivers
to better assist the parents and to make better treatment decisions and gauge response
at any hour.

HYPOTHESES

HCCC will be associated with:

1. A >40% reduction in treatment days outside the home (in a clinic, ED visits or
hospital) per child-year from enrollment to the end of the trial (primary hypothesis);

2. A decrease in school absences with respiratory problems to <5 d per school year;

3. An increase in FEV1>12% in routine pulmonary function tests in our clinic at 12 mo.
after enrollment;

4. Increased maternal satisfaction on the Consumer Assessment of Healthcare Providers and
Systems Survey;

5. Reduced or low net health system costs relative to that reported for common treatment
methods for asthma (expressed as health system cost per clinic visit, ED visit,
hospitalization, or school absence prevented);

6. Reduced Medicaid costs (due to lower reimbursements for clinic, ED, and hospital care);

7. An increase in medical school costs relative to reimbursements that will be lower than
the savings to Medicaid (due to its reduction in reimbursements). Such a difference
will be important in efforts to promote adequate reimbursements for such care to the
medical school

OBJECTIVES:

1.To randomize 80 eligible children to either standard HRCC or to HCCC in addition to HRCC
in a pilot trial and evaluate whether the augmentation of the HCCC program will:

1. reduce total days when medical treatment is given outside the home (in a clinic, ED, or
hospital);

2. reduce days of school missed with respiratory illnesses (including respiratory
infections with symptoms aggravated by asthma);

3. improve routine pulmonary function tests one year after enrollment;

4. augment maternal satisfaction of care above even the high current levels for CC;

5. reduce costs from a health system perspective and government (Medicaid) perspective

6. increase costs relative to reimbursements from the provider (medical school)
perspective

STUDY DESIGN:

Pilot trial of 80 severe asthmatics attending the HRCC that includes 24/7 cell phone access
to skilled primary caregivers or to HRCC with the addition of HCCC that will also include:
1) monitoring and augmenting treatment adherence using a special sensor to track inhaler use
and identify inadequate or excessive medication; 2) using a simple hand-held PIKO-1 device
to assess and transmit to caregivers the 1-second forced expiratory volume, allowing
caregivers to better assist the parents and to make better treatment decisions and gauge
response at any hour.

The pilot trial will have duration of 2 years. We will measure efficacy based on increase
FEV1 in routine pulmonary function test, reduced total days spent in clinics, Emergency
departments and hospital, and well as reduced total days of school missed due to pulmonary
illness. Safety will be assessed by looking at any unexpected adverse events.

With parental consent, we can also augment our care through use of Linked In to visualize
the child and assess his/her condition. We recently surveyed our asthma patients given CC
and to our surprise found that 75% (30/42) have access to "Linked in" on their home computer
or smart phone.

Inclusion Criteria:

- Children with severe asthma (poorly controlled by NIH guidelines ) who meet the
inclusion criteria for HRCC (>3 ED visits, >2 hospitalizations, or >1 pediatric ICU
admission in past as well as a >50% estimated risk of hospitalization in next yr).

Exclusion Criteria:

- other major lung disease (e.g. cystic fibrosis or bronchopulmonary dysplasia) or
neuromuscular impairment.