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NCT00691171 Clinical Trial

Electronic Health Record (EHR)-Based Intervention for Gastroesophageal Reflux Disease (GERD) and Chronic Non-steroidal Anti-inflammatory Drug (NSAID) Use

GERD Clinical Trial

Official title:
Using an Electronic Health Record-based Intervention and Broad Education Reach Strategies to Improve Quality of Care for GERD and Gastroprotection for Patients on NSAIDs: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00691171
Other study ID # NIS-GUS-DUM-2007/1
Secondary ID
Status Completed
Phase N/A
First received May 30, 2008
Last updated April 14, 2015
Start date January 2007
Est. completion date June 2008

Study information
Verified date April 2015
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of the study is to examine the impact of augmented, high-quality physician-coordinated care executed via an electronic health record (EHR)-based intervention on quality of care for gastroesophageal reflux disease (GERD) and for gastroprotection for patients on chronic non-steroidal anti-inflammatory drugs (NSAIDs) at increased risk for upper GI tract ulcers and ulcer related complications.

Recruitment information / eligibility
Status Completed
Enrollment 5234
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Eligibility as determined by criteria for participation in studies as part of the MQIC

- Agreement of participating clinical practices to undergo training in the electronic health record (EHR) intervention designed for this study

Exclusion Criteria:

- Based on voluntary participation by MQIC practices, so practices were excluded if they decided to opt out

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

References & Publications (1)

Gill JM, Mainous AG 3rd, Koopman RJ, Player MS, Everett CJ, Chen YX, Diamond JJ, Lieberman MI. Impact of EHR-based clinical decision support on adherence to guidelines for patients on NSAIDs: a randomized controlled trial. Ann Fam Med. 2011 Jan-Feb;9(1):2 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnoses of GERD After 12 months of intervention No
Primary Prescriptions for gastroprotective medicines in at-risk, chronic NSAID users After 12 months of intervention No
Secondary Prescriptions for GERD medications After 12 months of intervention No
Secondary Change in GERD symptoms score After 12 months of intervention No
Secondary NSAID-related GI complications After 12 months of intervention No
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