An interventional study of Enhanced Pharmacy Care and Control in Asthma, sponsored by Stephen J. Teach, MD, MPH. Completed at 1 site in United States. Open to participants aged 12 Months to 12 Years. Per ClinicalTrials.gov, last updated 2015-08-25.
Sponsored by Stephen J. Teach, MD, MPH · Not applicable, Interventional, and Treatment
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 125 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Stephen J. Teach, MD, MPH is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion criteria include:
Exclusion Criteria:
Exclusion criteria include:
Received enhanced community pharmacy based services.
Behavioral: Enhanced Pharmacy Care · Behavioral: Control
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.
Compliance with inhaled corticosteroids
Time frame: 6 months following enrollment
Unscheduled healthcare utilization for asthma
Time frame: 6 months following enrollment
Quality of Life
Time frame: 6 months following enrollment
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Stephen J. Teach, MD, MPH