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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00691171

Purpose

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
GERD

MedlinePlus related topics: GERD

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, 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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

Groups/Cohorts
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)

Eligibility

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)

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

Contacts and Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

James M Gill, MD, PhD

Delaware Valley Outcomes Research

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Douglas S. Levine, MD / Executive Director, Strategic Development )
Study ID Numbers:	NIS-GUS-DUM-2007/1
Study First Received:	May 30, 2008
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00691171
Health Authority:	United States: Institutional Review Board

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

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases

Ulcer
Esophageal Diseases
Gastroesophageal Reflux
Peptic Ulcer

ClinicalTrials.gov processed this record on January 15, 2009