ED-Initiated School-based Asthma Medication Supervision
Condition: Asthma; Asthma in Children
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Asthma is a common chronic condition that causes substantial morbidity among children and
      much of it is attributable to medication non-adherence. The National Asthma Education and
      Prevention Program (NAEPP) and the American Academy of Asthma, Allergy, and Immunology have
      urged others to develop more effective adherence programs.Schools are a logical setting to
      deploy such interventions because they are where children congregate, spend much of their
      day, and are frequently monitored. Because many schools serve a high proportion of minority
      and low-income students, engaging them presents a unique opportunity to reach populations who
      experience the greatest burden of preventable morbidity.

      Supervising inhaled corticosteroid (ICS) use in the school setting can increase medication
      adherence and reduce episodes of poor asthma control. Under certain conditions, it can also
      be cost-effective. However, recruiting children from school settings tends to enroll children
      with mild asthma and infrequent health care use. Therefore, initiating supervised treatment
      in these children tends to burden school personnel with unnecessary work and diminishes the
      program's cost-effectiveness. To address this inefficiency, the investigators propose to
      recruit children who are discharged from the Hospital Emergency Departments (EDs) following
      successful treatment of an asthma attack. Such children have much higher risk of a future
      asthma attack than their peers.

      The Pediatric Emergency Care Applied Research Network (PECARN) com- prises10
      hospital-affiliated EDs that serve 1 million acutely ill and injured children annually. Their
      primary research mission is to reduce childhood morbidity and mortality by establishing
      creative partnerships between emergency medical service providers and their surrounding
      communities. The networks size and geographic diversity make it uniquely situated to develop,
      implement, and evaluate the feasibility and effectiveness of ED-Initiated School-Based Asthma
      Medication Supervision (ED-SAMS).

      Approximately one-third of children treated for an asthma attack within PECARN experience a
      second ED-managed attack within 6 months. While the NAEPP guidelines recommend that long-term
      ICS treatment should be initiated at ED discharge, <20% of children actually receive a
      prescription for controller therapy. Observational data indicate that patients who use ICS
      following discharge are almost half as likely as non-users to experience a repeat ED visit.
      Many have also argued that ED-initiated treatment could be cost-effective. However, simply
      providing patients with a prescription does not ensure that they will actually use it once
      discharged. To ensure better medication adherence, the investigators propose to dispense ICS
      at discharge and supervise its use in the school setting.
    

Detailed description: 
      Approximately 8% of children in the United States have asthma. Each year, these children
      experience 4 million asthma attacks that result in 725,000 ED visits and 100,000
      hospitalizations. Unsurprisingly, the direct medical expenditures of children with asthma are
      75-90% higher than those of children without asthma. In 2016, this amount totaled 40 billion
      dollars. Substantial indirect costs are incurred when parents miss work to care for their
      children who miss school. These additional costs raise the total economic burden of asthma to
      $80 billion annually. Frequent asthma-related school absences impair academic achievement and
      social functioning. This burden falls disproportionately on minority, low-income, and urban
      populations. For example, black children have 60% more ED visits and 75% more
      hospitalizations than white children even though they have similar asthma attack rates.

      Adherence to ICS is notoriously poor.20, 22, 23 While 86% of privately insured patients who
      receive an ICS prescription will refill it within 30 days, only 64% will subsequently refill
      it again within 180 days. Even worse, only 3% will refill enough medication to cover greater
      than or equal to 75% of prescribed days with average medication possession being
      approximately 20%. Black and Hispanic patients are 20% less likely to refill their initial
      prescription and are 40% less likely to refill enough medication to cover greater than or
      equal to 75% of prescribed days. Adherence is similarly poor among the publicly insured.
      Among Medicaid-insured children, ICS is only refilled enough to cover 20% of prescribed days;
      fewer than 15% will refill enough to cover greater than or equal to 50% of days. At any given
      time, 40% of children with asthma are not well-controlled and much of this is attributable to
      nonadherence. Simulation and modeling studies suggest that maximizing ICS adherence among
      those prescribed ICS could reduce health care utilization by 25-45%. Even greater reductions
      are hypothesized if ICS prescribing could be expanded to all patients at risk of serious
      asthma-related exacerbations. However, a recent Cochrane review concluded that current
      methods of improving adherence for chronic health problems are mostly complex and not very
      effective. New adherence strategies will be needed if society is to achieve the gains
      suggested possible by simulations. Medication non-adherence among patients with chronic
      disease is a multi-dimensional challenge. The cost and convenience of obtaining medication
      (health system factors) and the motivation needed to adhere with a daily health habit
      (patient-related factors) are common barriers to adherence that are addressed by this study.
      Medication acquisition costs deter patients from refilling and refilling prescription
      medications. Even small $1-3 co-payments can appreciably reduce adherence. However, imposing
      additional time costs by requiring more frequent refills has an even greater impact. Time
      costs can add $50-100 per prescription. Therefore, the $155 out-of-pocket spending estimate
      for children's asthma medication likely understates the true economic burden. Dispensing ICS
      in the ED is therefore expected to improve adherence by reducing the substantial time and
      travel costs associated with medication acquisition. ICS treatment also burdens patients by
      requiring them to adopt a daily health habit. For children, this burden primarily falls on
      parents. Parents weigh the perceived benefits of treatment against their perceptions of
      treatment risk and burden. Given that asthma symptoms fluctuate in response to treatment and
      season, many purposefully reduce medication administration when their child's symptoms wane
      (volitional non-adherence).

      In the absence of treatment, the underlying inflammation is allowed to worsen and
      exacerbation risk increases. This reactive pattern of medication use is substantiated by the
      fact that 37% of all prescriptions for ICS are refilled on the same day as prescriptions for
      oral corticosteroid, suggesting after the exacerbation, not before it.18 Even more
      disturbing, less than 50% of children who refilled a prescription for oral corticosteroid
      were ever noted to have refilled an ICS prescription, meaning most lacked any access to
      controller medication.18 Our proposal addresses the problem of primary non-adherence by
      dispensing medication in the ED and addresses non-adherence by arranging supervised use in
      the school setting.
    

Intervention name(s): ED-Dispensing home and school supervision
Intervention type(s): Drug
Intervention description(s): Oral prednisolone based on body weight to achieve a daily dose of 2mg/kg/day not to exceed 40 mg per day for 5 days or its equivalent (provided in the emergency department),
360 ug of budesonide inhalation powder once-daily for at-home use, and
albuterol sulfate as needed for relief of acute respiratory symptoms.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Group 1 receives the intervention: ED-Initiated School-based Asthma Medication Supervision (school and home asthma medication supervision). Group 2 receives usual care (home asthma medication supervision).
Masking: None (Open Label)
Primary purpose: Other