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Sponsors and Collaborators: |
Children's Research Institute National Association of Chain Drug Stores Foundation |
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Information provided by: | Children's Research Institute |
ClinicalTrials.gov Identifier: | NCT00424125 |
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.
Condition | Intervention |
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Asthma |
Behavioral: Enhanced Pharmacy Care |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Improving Pediatric Asthma Care in the District of Columbia (IMPACT DC)-Community Pharmacy Intervention |
Estimated Enrollment: | 125 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | March 2009 |
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.
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.
Ages Eligible for Study: | 12 Months to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion criteria include:
Exclusion Criteria:
Exclusion criteria include:
Contact: Stephen J Teach, MD, MPH | (202) 476-5134 | steach@cnmc.org |
Contact: Deborah M Quint, MPH | (202) 476-5514 | dquint@cnmc.org |
United States, District of Columbia | |
Children's National Medical Center | Recruiting |
Washington, District of Columbia, United States, 20010 | |
Contact: Stephen J Teach, MD, MPH 202-476-5134 steach@cnmc.org | |
Contact: Deborah M Quint, MPH (202) 476-5514 dquint@cnmc.org | |
Principal Investigator: Stephen J Teach, MD, MPH |
Principal Investigator: | Stephen J Teach, MD, MPH | Children's Research Institute |
Study ID Numbers: | IMPACT DC CPIT |
Study First Received: | January 17, 2007 |
Last Updated: | March 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00424125 |
Health Authority: | United States: Institutional Review Board |
Asthma Compliance Randomized clinical trial |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Immune System Diseases Bronchial Diseases |