Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03952286 |
| Other study ID # |
1R34HL137851 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2019 |
| Est. completion date |
January 1, 2021 |
Study information
| Verified date |
November 2021 |
| Source |
University of Arizona |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
