Home Centered Comprehensive Care (HCCC) for Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Standard comprehensive care; enhanced comprehensive care
Intervention type(s): Other; Other
Intervention description(s): Standard comprehensive care at High Risk Children's Clinic; standard comprehensive care at the High Risk Children's Clinic enhaced with new technologies:
If between 2 and 5 years old--> will receive Home-centered comprehensive care with the propeller
5 and above--> will receive home-centered comprehensive care with propeller and PIKO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Asthma