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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: May 30, 2008
Last updated: April 14, 2015
Last verified: April 2015
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.


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Diagnoses of GERD [ Time Frame: After 12 months of intervention ] [ Designated as safety issue: No ]
  • Prescriptions for gastroprotective medicines in at-risk, chronic NSAID users [ Time Frame: After 12 months of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prescriptions for GERD medications [ Time Frame: After 12 months of intervention ] [ Designated as safety issue: No ]
  • Change in GERD symptoms score [ Time Frame: After 12 months of intervention ] [ Designated as safety issue: No ]
  • NSAID-related GI complications [ Time Frame: After 12 months of intervention ] [ Designated as safety issue: No ]

Enrollment: 5234
Study Start Date: January 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
GERD: Patients with established diagnoses of GERD based on ICD-9 codes
Atypical GERD: Patients without an established diagnosis of GERD with atypical symptoms that could be due to GERD (e.g., asthma)
Chronic NSAID users: Patients using chronic NSAIDs who are at increased risk of GI complications (defined as previous diagnosis of peptic ulcer disease; age 75 or older; or concomitant use of corticosteroids, anticoagulants, or aspirin)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primarily primary care practices of physicians participating in the Medical Quality Improvement Consortium (MQIC)

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00691171

Sponsors and Collaborators
Principal Investigator: James M Gill, MD, PhD Delaware Valley Outcomes Research
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00691171     History of Changes
Other Study ID Numbers: NIS-GUS-DUM-2007/1 
Study First Received: May 30, 2008
Last Updated: April 14, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by AstraZeneca:
gastroesophageal reflux disease
nonsteroidal anti-inflammatory drugs
peptic ulcer
Diagnosed GERD
Atypical GERD symptoms
chronic NSAID therapy
Risk for ulcer

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Antirheumatic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016