- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01522144
An Electronic Decision Support Tool to Improve Outpatient Asthma Care
EHR Decision Support to Improve Outpatient Asthma Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
National Asthma Education and Prevention Program guidelines (NAEPP) exist, but are under used in Primary Care. In addition, implementation of the guidelines has been shown to be vary according to the location of practice and other contextual factors.
The Children's Hospital of Philadelphia Pediatric Research Consortium (PeRC), a practice-based research network will determine whether an innovative clinical decision support system embedded in an existing electronic health record (EHR) will improve provider adherence to the existing NAEPP guidelines.
After receiving a standardized education module based on NAEPP guidelines, 10 primary care pediatric practices (both urban and suburban) will be randomized to receive either a passive EHR (control sites) or an interactive decision support sytem (intervention sites).
The primary outcome of interest will be the proportion of patient son 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 17years) and 3) an updated problem list reflecting current asthma severity. After hours calls to providers and types of office visits related to to asthma will be tracked. Contextual factors at the clinic and patient level will be examined to assess their association with the outcomes of interest. 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
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.
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
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children with the diagnosis of asthma
- Children enrolled in one of 10 selected primary care practices in the PeRC practice-based research network
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Asthma clinical decision support
decision support compared to no decision support in a cluster-randomized trial by practise
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Using a clustered randomized method, computerized decision support, embedded in the electronic health record, was offered to selected primary care practices and outcomes of asthma care were compared to those practices without the computerized decision support.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The proportion of patients on appropriate asthma controller medication at the end of the trial
Time Frame: assessed at each visit
|
each patient who is classified as having persistant asthma should be on at least one appropriate controller medication for asthma.
|
assessed at each visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1) an updated asthma action plan
Time Frame: updated at least once per year
|
Each patient should have an asthma care plan updated once per year
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updated at least once per year
|
|
2)documentation of spirometry(6 to 18 yrs)in those with asthma
Time Frame: spirometry should be done once per year
|
Each patient should have had spirometry at least once per year.
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spirometry should be done once per year
|
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3) an updated problem list that reflects an assessment of asthma severity
Time Frame: tthe asthma severity should be on the problem list
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each patient should have their asthma severity classification on the thier chart
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tthe asthma severity should be on the problem list
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Louis M Bell, MD, Children's Hospital of Philadelphia
Publications and helpful links
General Publications
- Asthma mortality and hospitalization among children and young adults--United States, 1980-1993. From the Centers for Disease Control and Prevention. JAMA. 1996 May 22-29;275(20):1535-7. No abstract available.
- Lieu TA, Quesenberry CP Jr, Capra AM, Sorel ME, Martin KE, Mendoza GR. Outpatient management practices associated with reduced risk of pediatric asthma hospitalization and emergency department visits. Pediatrics. 1997 Sep;100(3 Pt 1):334-41. doi: 10.1542/peds.100.3.334.
- Landry P, Tremblay S, Darioli R, Genton B. Inactivated hepatitis A vaccine booster given >/=24 months after the primary dose. Vaccine. 2000 Oct 15;19(4-5):399-402. doi: 10.1016/s0264-410x(00)00188-2.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21HS014873 (U.S. AHRQ Grant/Contract)
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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