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

April 14, 2015 updated by: AstraZeneca

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

5234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primarily primary care practices of physicians participating in the Medical Quality Improvement Consortium (MQIC)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnoses of GERD
Time Frame: After 12 months of intervention
After 12 months of intervention
Prescriptions for gastroprotective medicines in at-risk, chronic NSAID users
Time Frame: After 12 months of intervention
After 12 months of intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Prescriptions for GERD medications
Time Frame: After 12 months of intervention
After 12 months of intervention
Change in GERD symptoms score
Time Frame: After 12 months of intervention
After 12 months of intervention
NSAID-related GI complications
Time Frame: After 12 months of intervention
After 12 months of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: James M Gill, MD, PhD, Delaware Valley Outcomes Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

May 30, 2008

First Submitted That Met QC Criteria

June 4, 2008

First Posted (Estimate)

June 5, 2008

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-GUS-DUM-2007/1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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