Asthma Clinical Trial
Official title:
Improving Pediatric Asthma Care in the District of Columbia (IMPACT DC)-Community Pharmacy Intervention
This study seeks to determine whether education provided in community pharmacies and monthly
reminder calls can improve compliance with asthma medications.
We hypothesize that those pediatric patients with asthma 12 months to 12 years of age who
receive comprehensive asthma care as part of a validated intervention (1) who are randomized
to receive enhanced community pharmacy care will have significantly greater compliance with
inhaled corticosteroids (ICS) six months after enrollment when compared with patients
receiving usual pharmacy care. As secondary outcomes, we further hypothesize that they will
have less unscheduled healthcare utilization and improved functional outcomes and QOL.
(1) Teach SJ, Crain EF, Quint DM, Hylan ML, Joseph JG. Improved Asthma Outcomes in a High
Morbidity Pediatric Population: Results of an Emergency Department-based Randomized Clinical
Trial. Archives of Pediatric and Adolescent Medicine. 2006;160:535-541.
IMPACT DC has been funded by the National Association of Chain Drug Stores Foundation
(NACDSF) to undertake a project regarding coordination between the existing IMPACT DC Asthma
Clinic and certain community pharmacies in Northwest, Northeast, and Southeast DC that
provide patients with asthma medications, devices, and education.
This is a single blind prospective randomized clinical trial in which eligible patients with
asthma aged 12m to 12y, inclusive, seen in the current IMPACT DC Asthma Clinic and
prescribed ICS as controller medications is randomized to either "usual pharmacy care" or
"enhanced pharmacy care." The IMPACT DC Asthma Clinic is an ED-based follow-up clinic that
has been shown to improve outcomes. (1)
Outcomes will be assessed by blinded and structured patient phone interview at 1, 3, and 6
months.
Patients randomized to usual pharmacy care will fill prescriptions by their usual preferred
method, whereas patients randomized to enhanced pharmacy care will have these same
prescriptions electronically transmitted to specifically trained pharmacists at one of the
participating community pharmacies. Both "usual pharmacy care" and "enhanced pharmacy care"
will be provided within all participating pharmacy sites.
Community pharmacies located in five zip codes in Northeast and Southeast DC with the
highest absolute numbers of pediatric ED asthma visits to hospital in the District (20019,
20020, 20032, 20002, 20011) will be selected for the program based on their geographic
distribution and ability to meet programmatic expectations. Pharmacies will receive
electronically transmitted, faxed or verbal prescriptions from the IMPACT DC Asthma Clinic
staff for patients identified as study participants in the intervention group.
Pharmacists will then provide real-time, targeted education around the purpose and use of
the new and refilled ICS medications to study participants and their families at each point
of contact, including rationale for their use, device teaching, dosage review, and
importance of compliance. Families randomized to "enhanced care" will also be contacted
monthly by phone and mail with reminders to fill their controller medications prescriptions
and to seek ongoing longitudinal asthma care with their primary care providers.
(1) Teach SJ, Crain EF, Quint DM, Hylan ML, Joseph JG. Improved Asthma Outcomes in a High
Morbidity Pediatric Population: Results of an Emergency Department-based Randomized Clinical
Trial. Archives of Pediatric and Adolescent Medicine. 2006;160:535-541.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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