Home Centered Comprehensive Care (HCCC) for Children With Asthma
Home Centered Comprehensive Care (HCCC) for Children With Asthma
The purpose of this study is to assess whether comprehensive care enhanced with new
 technology to optimize asthma care in the home (using both a special sensor to track inhaler
 use and a hand-held PIKO-1 device to assess patients' forced expiratory volume in the 1st
 second [FEV1]) is effective in reducing total days when medical treatment is given outside
 the home (in clinic, emergency department, or hospital) among children with severe asthma
 receiving comprehensive care.
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.