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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Pharmacy Care
Control
Sponsored by
Stephen J. Teach, MD, MPH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Compliance, Randomized clinical trial

Eligibility Criteria

12 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's National Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Enhanced Pharmacy Care

Arm Description

Received enhanced community pharmacy based services.

Outcomes

Primary Outcome Measures

Compliance with inhaled corticosteroids

Secondary Outcome Measures

Unscheduled healthcare utilization for asthma
Quality of Life

Full Information

First Posted
January 17, 2007
Last Updated
August 21, 2015
Sponsor
Stephen J. Teach, MD, MPH
Collaborators
National Association of Chain Drug Stores
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1. Study Identification

Unique Protocol Identification Number
NCT00424125
Brief Title
Involving Community Pharmacies in Improving Asthma Outcomes in an Urban Pediatric Population
Official Title
Improving Pediatric Asthma Care in the District of Columbia (IMPACT DC)-Community Pharmacy Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stephen J. Teach, MD, MPH
Collaborators
National Association of Chain Drug Stores

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Compliance, Randomized clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Pharmacy Care
Arm Type
Experimental
Arm Description
Received enhanced community pharmacy based services.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Pharmacy Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Usual care.
Primary Outcome Measure Information:
Title
Compliance with inhaled corticosteroids
Time Frame
6 months following enrollment
Secondary Outcome Measure Information:
Title
Unscheduled healthcare utilization for asthma
Time Frame
6 months following enrollment
Title
Quality of Life
Time Frame
6 months following enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Teach, MD, MPH
Organizational Affiliation
Children's National Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16651498
Citation
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. Arch Pediatr Adolesc Med. 2006 May;160(5):535-41. doi: 10.1001/archpedi.160.5.535.
Results Reference
background
Links:
URL
http://www.impact-dc.org
Description
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Involving Community Pharmacies in Improving Asthma Outcomes in an Urban Pediatric Population

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