Electronic Health Record (EHR) Decision Support to Improve Outpatient Asthma Care
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Intervention
Sponsored by
About this trial
This is an interventional health services research trial for Asthma focused on measuring clinical decision support tool, electronic health record, control tool, spirometry, quality of life survey, provider survey
Eligibility Criteria
Inclusion Criteria:
- Known patients with asthma
Exclusion Criteria:
- None
Sites / Locations
- The Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Control arm
Intervention arm
Arm Description
Practices with the EHR implemented will be randomized have the asthma disease management tools available passively (the control group).
The intervention sites will have decision support alerts and reminders activated to guide providers toward these tools in the appropriate situations.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00918944
First Posted
June 9, 2009
Last Updated
December 22, 2011
Sponsor
Children's Hospital of Philadelphia
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT00918944
Brief Title
Electronic Health Record (EHR) Decision Support to Improve Outpatient Asthma Care
Official Title
EHR Decision Support to Improve Outpatient Asthma Care
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
clinical decision support tool, electronic health record, control tool, spirometry, quality of life survey, provider survey
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control arm
Arm Type
Other
Arm Description
Practices with the EHR implemented will be randomized have the asthma disease management tools available passively (the control group).
Arm Title
Intervention arm
Arm Type
Other
Arm Description
The intervention sites will have decision support alerts and reminders activated to guide providers toward these tools in the appropriate situations.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The asthma disease management toolkit available to all practices in the EHR will consist of four elements:
A data entry tool for capturing asthma control data
Standardized documentation templates to facilitate severity classification
Order sets to facilitate ordering controller medications
An asthma care plan that can be supplied to families
Intervention Type
Other
Intervention Name(s)
Intervention
Intervention Description
Three alerts and two reminders will be programmed:
Alert providers to enter asthma severity classification if none is on file
Alert providers to prescribe controller medications for persistent asthma if none on file
Alert providers to complete an asthma care plan if none on file
Remind providers to review the asthma care plan if it is already on file by providing a link to the form
Remind providers that educational content is available on-line by providing a web link
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Known patients with asthma
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis M Bell, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Electronic Health Record (EHR) Decision Support to Improve Outpatient Asthma Care
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