Skip to main content
OpenTrials
Completed

NCT Number: NCT00424125

Involving Community Pharmacies in Improving Asthma Outcomes in an Urban Pediatric Population

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

12 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria include:
  • age between 12 months and 12 years, inclusive;
  • prior physician-diagnosed asthma;
  • prescription of an inhaled corticosteroid during the IMPACT DC Asthma Clinic visit,
  • a parent/guardian available for interview;
  • residence in one of the 5 zip codes in Washington, DC with the highest absolute numbers for asthma visits to the Emergency Department at Childrens National Medical Center (20019, 20020, 20032, 20002, 20011), and
  • insurance that covers at least part of the cost of medications.

Exclusion criteria

  • Exclusion criteria include:
  • significant medical co-morbidities affecting the cardiorespiratory system;
  • enrollment in another asthma research study;
  • unavailability for telephone follow-up; or
  • primary language other than English.

Treatment and study plan

Enhanced Pharmacy Care

Behavioral

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.

Control

Behavioral

Usual care.

Primary outcomes

  1. Compliance with inhaled corticosteroids

    Time frame: 6 months following enrollment

Secondary outcomes

  1. Unscheduled healthcare utilization for asthma

    Time frame: 6 months following enrollment

  2. Quality of Life

    Time frame: 6 months following enrollment

Sponsors and collaborators

Lead sponsor

Stephen J. Teach, MD, MPH

Other

Collaborators

  • National Association of Chain Drug Stores

Registry information

Official study title

Improving Pediatric Asthma Care in the District of Columbia (IMPACT DC)-Community Pharmacy Intervention

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 18, 2007
Registry last updated
Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.