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

This study has been completed.
Sponsor:
Collaborator:
National Association of Chain Drug Stores
Information provided by (Responsible Party):
Children's Research Institute
ClinicalTrials.gov Identifier:
NCT00424125
First received: January 17, 2007
Last updated: December 13, 2011
Last verified: December 2011
  Purpose

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
Asthma
Behavioral: Enhanced Pharmacy Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Pediatric Asthma Care in the District of Columbia (IMPACT DC)-Community Pharmacy Intervention

Resource links provided by NLM:


Further study details as provided by Children's Research Institute:

Primary Outcome Measures:
  • Compliance with inhaled corticosteroids [ Time Frame: 6 months following enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Unscheduled healthcare utilization for asthma [ Time Frame: 6 months following enrollment ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 6 months following enrollment ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: July 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Enhanced Pharmacy Care

    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.

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.

  Eligibility

Ages Eligible for Study:   12 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria include:

    1. age between 12 months and 12 years, inclusive;
    2. prior physician-diagnosed asthma;
    3. prescription of an inhaled corticosteroid during the IMPACT DC Asthma Clinic visit,
    4. a parent/guardian available for interview;
    5. 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
    6. insurance that covers at least part of the cost of medications.

Exclusion Criteria:

  • Exclusion criteria include:

    1. significant medical co-morbidities affecting the cardiorespiratory system;
    2. enrollment in another asthma research study;
    3. unavailability for telephone follow-up; or
    4. primary language other than English.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00424125

Locations
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Children's Research Institute
National Association of Chain Drug Stores
Investigators
Principal Investigator: Stephen J Teach, MD, MPH Children's Research Institute
  More Information

Additional Information:
Publications:
Responsible Party: Children's Research Institute
ClinicalTrials.gov Identifier: NCT00424125     History of Changes
Other Study ID Numbers: IMPACT DC CPIT
Study First Received: January 17, 2007
Last Updated: December 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Research Institute:
Asthma
Compliance
Randomized clinical trial

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014