Economic Impact of Guidelines for Gastroesophageal Reflux Disease

• Status: Completed
• Trial end date: 2004-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a series of two prospective studies based on the Department of Veterans Affairs drug treatment guideline for the pharmacologic management of gastroesophageal reflux disease. Our hypothesis is that novel strategies for medical management of gastroesophageal reflux disease (GERD) can decrease resource utilization without adversely affecting patient quality of life. The strategies tested in this project included 1) step-down management, whereby patients rendered asymptomatic on proton pump inhibitors (PPIs) are treated with less expensive medication, and 2) intermittent therapy, defined as administration of medication only for recurrence of GERD symptoms. We chose to examine an intermittent strategy of PPI administration since in addition to the VA guideline requiring step-down therapy, over-the-counter PPIs administered by intermittent therapy became available for use by patients during the study period.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development
• Collaborator: Oregon Health and Science University

Criteria

Inclusion Criteria:

1. Patients with GERD symptoms treated with PPIs. For the purpose of this study, GERD symptoms include heartburn or acid regurgitation. Symptoms of dyspepsia (epigastric pain, nausea, bloating, early satiety) may be present, but may not be used as the sole criteria for inclusion into the study.

2. Asymptomatic (no heartburn or acid regurgitation) on PPI therapy.

Exclusion Criteria:

1. Complications of gastroesophageal reflux disease including esophageal stricture, hemorrhage due to erosive esophagitis, Barrett�s esophagus or adenocarcinoma of the esophagus, or extra-esophageal manifestations of reflux disease (pulmonary or laryngeal disease due to acid reflux).

2. Concurrent diagnoses of other gastrointestinal diseases including gastric or duodenal ulcer, Zollinger-Ellison syndrome or other hypersecretory disorders, or gastric cancer.

3. Esophagitis secondary to non-acid peptic causes: infections (viral, bacterial, fungal), or medications causing esophageal erosions.

4. Inability to maintain follow-up, either due to excessive distance to the VA primary care facility or lack of telephone services.

5. Unwillingness to participate in the study.