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

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ClinicalTrials.gov Identifier: NCT00691171
Recruitment Status : Completed
First Posted : June 5, 2008
Last Update Posted : April 15, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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.

Condition or disease
GERD

Study Type : Observational
Actual Enrollment : 5234 participants
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
Study Start Date : January 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Group/Cohort
1
GERD: Patients with established diagnoses of GERD based on ICD-9 codes
2
Atypical GERD: Patients without an established diagnosis of GERD with atypical symptoms that could be due to GERD (e.g., asthma)
3
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)



Primary Outcome Measures :
  1. Diagnoses of GERD [ Time Frame: After 12 months of intervention ]
  2. Prescriptions for gastroprotective medicines in at-risk, chronic NSAID users [ Time Frame: After 12 months of intervention ]

Secondary Outcome Measures :
  1. Prescriptions for GERD medications [ Time Frame: After 12 months of intervention ]
  2. Change in GERD symptoms score [ Time Frame: After 12 months of intervention ]
  3. NSAID-related GI complications [ Time Frame: After 12 months of intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691171


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

Publications of Results:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00691171     History of Changes
Other Study ID Numbers: NIS-GUS-DUM-2007/1
First Posted: June 5, 2008    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015

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

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