Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424125
Status:
COMPLETED
Last Update Posted:
2015-08-25
First Post:
2007-01-17
Brief Title:
Involving Community Pharmacies in Improving Asthma Outcomes in an Urban Pediatric Population
Sponsor:
Stephen J Teach MD MPH
Organization:
Childrens National Research Institute
Study Overview
Official Title:
Improving Pediatric Asthma Care in the District of Columbia IMPACT DC-Community Pharmacy Intervention
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 2006160535-541
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 2006160535-541
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 2006160535-541
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 2006160535-541
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None