AsthmaNCT00424125
Involving Community Pharmacies in Improving Asthma Outcomes in an Urban Pediatric Population
A study testing Enhanced Pharmacy Care in people with Asthma, run by Stephen J. Teach, MD, MPH at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 12 months to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Enhanced Pharmacy Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Improving Pediatric Asthma Care in the District of Columbia (IMPACT DC)-Community Pharmacy Intervention
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Enhanced Pharmacy Care, Control
- Keywords
- Asthma, Compliance, Randomized clinical trial
- Medical subject headings
- Asthma, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Pharmacy CareBehavioural
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.
ControlBehavioural
Usual care.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Pharmacy Care | Experimental | Received enhanced community pharmacy based services. Receives: Behavioral: Enhanced Pharmacy Care; Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with inhaled corticosteroids
Measured: 6 months following enrollment
Secondary outcomes (2)
Unscheduled healthcare utilization for asthma
Measured: 6 months following enrollment
Quality of Life
Measured: 6 months following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startJul 2006
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen J. Teach, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- National Association of Chain Drug Stores
- Responsible party
- Sponsor-investigator, Stephen J. Teach, MD, MPH, Children's National Research Institute
- Investigators
- Stephen J Teach, MD, MPH, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424125
- Sponsor's protocol ID
- IMPACT DC CPIT
- Status last verified
- Aug 2015
- First submitted
- 17 Jan 2007
- Last updated
- 25 Aug 2015
- Results posted
- No
Publications
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.
PubMed 16651498
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Pediatric Asthma Care in the District of Columbia (IMPACT DC)-Community Pharmacy Intervention
- ClinicalTrials.gov ID
- NCT00424125
- Acronym / sponsor ID
- IMPACT DC CPIT
- Conditions
- Asthma
- Keywords
- Asthma, Compliance, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Stephen J. Teach, MD, MPHUniversity, hospital or other
- Collaborators
- National Association of Chain Drug Stores
- Study start
- Jul 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 18 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enhanced Pharmacy Care | Experimental | Behavioral: Enhanced Pharmacy Care, Behavioral: ControlReceived enhanced community pharmacy based services. |
Who may qualify
- Ages
- 12 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
Key exclusion criteria (4 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Pharmacy CareParticipants 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. | Behavioural | Enhanced Pharmacy Care |
| ControlUsual care. | Behavioural | Enhanced Pharmacy Care |
Primary outcome
Compliance with inhaled corticosteroids
Time frame: 6 months following enrollment
2 secondary outcomes
Unscheduled healthcare utilization for asthma
Time frame: 6 months following enrollment
Quality of Life
Time frame: 6 months following enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
- Background: PubMed 16651498Teach 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J Teach, MD, MPH principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Pharmacy Care in people with Asthma, run by Stephen J. Teach, MD, MPH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with inhaled corticosteroids (time frame: 6 months following enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00424125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2015.