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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01522144
Other study ID # R21HS014873
Secondary ID
Status Completed
Phase N/A
First received January 19, 2012
Last updated January 27, 2012
Start date July 2006
Est. completion date August 2008

Study information

Verified date January 2012
Source Agency for Healthcare Research and Quality (AHRQ)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The Children's Hospital of Philadelphia's ambulatory network uses an electronic health record (EHR) to document clinical information. Using the EHR, a clinical decision support tool will be designed to help the primary care physician's in caring for children with asthma. The goal will be to improve the primary care physician's use of the national Institutes of Health guidelines for the best care for asthma. To study this EHR decision support tool, it will be introduced into 5 practices while 5 other practices will have the existing asthma care information. It will be determined whether the physicians in the practices with the decision support tool are better at following the asthma guidelines. If the decision support tool works...then it will be offered to others to use with their EHR systems.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1030
Est. completion date August 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 18 Years
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
Computerized Decision support
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.

Locations

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

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of patients on appropriate asthma controller medication at the end of the trial each patient who is classified as having persistant asthma should be on at least one appropriate controller medication for asthma. assessed at each visit No
Secondary 1) an updated asthma action plan Each patient should have an asthma care plan updated once per year updated at least once per year No
Secondary 2)documentation of spirometry(6 to 18 yrs)in those with asthma Each patient should have had spirometry at least once per year. spirometry should be done once per year No
Secondary 3) an updated problem list that reflects an assessment of asthma severity each patient should have their asthma severity classification on the thier chart tthe asthma severity should be on the problem list No
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