This project has three main objectives: 1) to compare total costs of GERD management in subjects managed by step-down care with controls in whom step-down is deferred, 2) to compare quality of life in GERD patients managed by step-down care with controls and determine the cost-effectiveness of step-down care, and 3) to determine patient factors predictive of non-response to step-down care.

Condition	Treatment or Intervention
Gastroesophageal Reflux	Drug: Disease management of gastroesophageal reflux disease

This is a prospective study of the Department of Veterans Affairs drug treatment guideline for the pharmacologic management of gastroesophageal reflux disease. Our hypothesis is that step-down management of gastroesophageal reflux disease (GERD), whereby patients rendered asymptomatic on proton-pump inhibitors are treated with less expensive medication, can decrease resource utilization without adversely affecting patient quality of life. This project has three main objectives: 1) to compare total costs of GERD management in subjects managed by step-down care with controls in whom step-down is deferred, 2) to compare quality of life in GERD patients managed by step-down care with controls and determine the cost-effectiveness of step-down care, and 3) to determine patient factors predictive of non-response to step-down care.

Patients with GERD asymptomatic on proton-pump inhibitors (PPI) will be randomized to either immediate or deferred (controls) step-down care. Step-down will commence with discontinuation of PPIs in favor of less expensive medication, while controls will continue PPI therapy. Both groups will be managed through a clinic staffed by clinical pharmacists. Management decisions will be made in a blinded fashion based on the VA guideline. Follow up in both groups will occur at three-month intervals for the period of one year after randomization. Four data sets will be collected: 1) subject baseline characteristics, 2) pharmacy expenditures, 3) non-pharmacy resource utilization, and 4) quality of life (generic and disease-specific instruments). The primary outcome measure is total resource utilization (pharmacy and non-pharmacy) of subjects managed by step-down compared with controls. Secondary outcome measures will examine differences in quality of life and cost-effectiveness of step-down care, and establish predictors of non-response to step-down care (requirement of PPI to control symptoms). Logistic regression and random-effects models will adjust for covariates and clustering effects.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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
• Asymptomatic (no heartburn or acid regurgitation) on PPI therapy

Exclusion Criteria:

• 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)
• Concurrent diagnoses of other gastrointestinal diseases including gastric or duodenal ulcer, Zollinger-Ellison syndrome or other hypersecretory disorders, or gastric cancer
• Esophagitis secondary to non-acid peptic causes: infections (viral, bacterial, fungal), or medications causing esophageal erosions
• Inability to maintain follow-up, either due to excessive distance to the VA primary care facility or lack of telephone services
• Unwillingness to participate in the study

Michigan
      VA Ann Arbor Health Care System, Ann Arbor,  Michigan,  48113-0170,  United States; Recruiting

Study ID Numbers:  IIR 99-238
Record last reviewed:  March 2004
Record first received:  March 27, 2003
ClinicalTrials.gov Identifier:  NCT00057174
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09