Involving Community Pharmacies in Improving Asthma Outcomes in an Urban Pediatric Population
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Enhanced Pharmacy Care; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants randomized to "Enhanced Pharmacy Care" will have their prescriptions electronically transmitted or faxed to one of the five participating pharmacies.
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.; Usual care.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Compliance; Randomized clinical trial