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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00918944
Other study ID # 2005-11-4596
Secondary ID
Status Completed
Phase N/A
First received June 9, 2009
Last updated December 22, 2011
Start date January 2006
Est. completion date August 2009

Study information

Verified date December 2011
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date August 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Known patients with asthma

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
United States The Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months Yes
Secondary 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. 6 months No
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