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Electronic Health Record (EHR) Decision Support to Improve Outpatient Asthma Care

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00918944
First received: June 9, 2009
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

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).


Condition Intervention
Asthma
Other: Control
Other: Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: EHR Decision Support to Improve Outpatient Asthma Care

Further study details as provided by Children's Hospital of Philadelphia:

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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: January 2006
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control arm
Practices with the EHR implemented will be randomized have the asthma disease management tools available passively (the control group).
Other: Control

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 arm
The intervention sites will have decision support alerts and reminders activated to guide providers toward these tools in the appropriate situations.
Other: Intervention

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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Known patients with asthma

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00918944

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Louis M Bell, MD Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00918944     History of Changes
Other Study ID Numbers: 2005-11-4596
Study First Received: June 9, 2009
Last Updated: December 22, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
clinical decision support tool
electronic health record
control tool
spirometry
quality of life survey
provider survey

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 23, 2014