- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00918944
Electronic Health Record (EHR) Decision Support to Improve Outpatient Asthma Care
EHR Decision Support to Improve Outpatient Asthma Care
To determine whether an innovative clinical decision support system embedded in an existing electronic health record (EHR) will improve provider adherence to the existing National Asthma Education and Prevention Program (NAEPP) guidelines.
12 primary care pediatric practices at The Children's Hospital of Philadelphia(both urban and suburban sites) will be randomized to receive either a passive EHR (control sites) or an interactive decision support system (intervention sites).
Study Overview
Detailed Description
After receiving a standardized education module based on NAEPP guidelines, 12 primary care pediatric practices (both urban and suburban sites) will be randomized to receive either a passive EHR (control sites) or an interactive decision support system (intervention sites).
The primary outcome of interest will be the proportion of patients on appropriate asthma controller medication compared over time. Secondary outcomes include the proportion of asthma patients with: 1) an updated asthma action plan 2) documentation of spirometry performed (6 to 17 yrs) and 3) an updated problem list reflecting current asthma severity. After hours calls to providers and types of office visits related to asthma will be tracked. 4) In addition, measurement of asthma-related quality of life and missed school and work in a sample of 200 subjects from each group will be performed. Contextual factors at the clinic and patient level will be examined to assess their association with outcomes of interest.
If shown to be successful, this type of clinical decision support, embedded within the EHR, has the potential to be a powerful tool to improve the implementation of asthma guidelines and clinical practice guidelines for other conditions and illnesses in the primary setting.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- The Children's Hospital of Philadelphia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Known patients with asthma
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Control arm
Practices with the EHR implemented will be randomized have the asthma disease management tools available passively (the control group).
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The asthma disease management toolkit available to all practices in the EHR will consist of four elements:
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Other: Intervention arm
The intervention sites will have decision support alerts and reminders activated to guide providers toward these tools in the appropriate situations.
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Three alerts and two reminders will be programmed:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The primary outcome measure is the proportion of persistent asthmatic patients with at least one prescription for a controller medication in each period. There are two periods of study: baseline and intervention.
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Secondary outcomes include the proportion of persistent asthmatic patients with 1)an updated asthma action plan, 2)spirometry as needed 3)problem list with current asthma severity 4)asthma-related quality of life scores 5)absent school and work days.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Louis M Bell, MD, Children's Hospital of Philadelphia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005-11-4596
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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