Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by AstraZeneca.
Recruitment status was  Active, not recruiting
Information provided by:
AstraZeneca Identifier:
First received: May 30, 2008
Last updated: June 4, 2008
Last verified: June 2008

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 ]

Study Start Date: January 2007
Estimated Study Completion Date: July 2008
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
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 identifier: NCT00691171

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

No publications provided

Responsible Party: Douglas S. Levine, MD / Executive Director, Strategic Development, AstraZeneca Pharmaceuticals Identifier: NCT00691171     History of Changes
Other Study ID Numbers: NIS-GUS-DUM-2007/1
Study First Received: May 30, 2008
Last Updated: June 4, 2008
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 processed this record on March 03, 2015