Economic Impact of Guidelines for Gastroesophageal Reflux Disease

NCT ID: NCT00057174

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 484 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2004-06-30

Brief 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.

Detailed Description

Background:

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.

Objectives:

The objectives of this project are to determine the efficacy of step-down therapy and intermittent therapy in patients with GERD, and the impact of these strategies on direct healthcare costs and health-related quality of life (HRQOL). Additionally, we will examine patient factors predictive of non-response to these management strategies that may be alternatives to traditional continuous PPI administration.

Methods:

Two separate studies were conducted in our population of patients with GERD symptoms (heartburn or acid regurgitation) rendered asymptomatic on PPIs. Both studies randomized subjects to an intervention strategy (Step-down or Intermittent therapy) or to a control group in which PPIs were continued on a daily basis.

Step-down therapy: Step-down subjects discontinued PPIs and were prescribed histamine2-receptor antagonists (H2RAs) for 2 weeks, and if still asymptomatic, H2RAs were discontinued. If symptoms recurred, H2RAs were reinitiated, and if still symptomatic, subjects were prescribed PPIs at the dose that initially alleviated their symptoms. Intermittent therapy: Intermittent therapy subjects discontinued daily use of PPIs and were prescribed short courses of PPI (daily for 8 weeks) for recurrence of GERD symptoms. The primary efficacy measure was the proportion of subjects remaining free of GERD symptoms while on their prescribed therapy (step-down group: no symptoms on H2RAs or no GERD medication; intermittent therapy group: no PPIs for �2 weeks after discontinuation, and < 3 symptom recurrences requiring PPIs; control groups: no GERD symptoms on PPI). Follow up was conducted for 6 months after randomization. In addition to the primary efficacy measure, we examined total resource utilization (pharmacy and non-pharmacy), HRQOL, and potential predictors of non-response to step-down or intermittent therapy (requirement of daily PPI to control symptoms). Logistic regression and random-effects models adjusted for covariates and clustering effects.

Status:

Enrollment and follow-up have been completed. Efficacy measures are reported above. Outcome measures including comparison of direct health care costs, health-related quality of life, and determinants of non-response to step-down or intermittent therapy are being examined.

Conditions

Gastroesophageal Reflux Disease; Health Economics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1

Group Type: OTHER

Disease management of gastroesophageal reflux disease

Intervention Type: DRUG

Interventions

Disease management of gastroesophageal reflux disease

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Inadomi, MD

Role: PRINCIPAL_INVESTIGATOR

VA Ann Arbor Healthcare System, Ann Arbor, MI

Locations

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

Countries

United States

References

El-Serag HB, Graham DY, Richardson P, Inadomi JM. Prevention of complicated ulcer disease among chronic users of nonsteroidal anti-inflammatory drugs: the use of a nomogram in cost-effectiveness analysis. Arch Intern Med. 2002 Oct 14;162(18):2105-10. doi: 10.1001/archinte.162.18.2105.

Reference Type: RESULT

PMID: 12374519 (View on PubMed)

Rubenstein JH, Inadomi JM. Empiric beta-blockers for the prophylaxis of variceal hemorrhage: cost effective or clinically applicable? Hepatology. 2003 Feb;37(2):249-52. doi: 10.1053/jhep.2003.50089. No abstract available.

Reference Type: RESULT

PMID: 12540773 (View on PubMed)

Rubenstein JH, Inadomi JM. Dysphagia drives doctors to diagnose a disease: pitfalls in interpreting observational studies. Gastrointest Endosc. 2005 Jun;61(7):809-11. doi: 10.1016/s0016-5107(05)00544-4. No abstract available.

Reference Type: RESULT

PMID: 15933680 (View on PubMed)

Rubenstein JH, Vakil N, Inadomi JM. The cost-effectiveness of biomarkers for predicting the development of oesophageal adenocarcinoma. Aliment Pharmacol Ther. 2005 Jul 15;22(2):135-46. doi: 10.1111/j.1365-2036.2005.02536.x.

Reference Type: RESULT

PMID: 16011672 (View on PubMed)

Rubenstein JH, Davis J, Marrero JA, Inadomi JM. Relationship between diabetes mellitus and adenocarcinoma of the oesophagus and gastric cardia. Aliment Pharmacol Ther. 2005 Aug 1;22(3):267-71. doi: 10.1111/j.1365-2036.2005.02544.x.

Reference Type: RESULT

PMID: 16091065 (View on PubMed)

Rhee J, Scheiman J, Inadomi J. "Spontaneous" passage of a pancreatic duct stone. Gastrointest Endosc. 2003 Feb;57(2):278-80. doi: 10.1067/mge.2003.62. No abstract available.

Reference Type: RESULT

PMID: 12556808 (View on PubMed)

Chey WD, Inadomi JM, Booher AM, Sharma VK, Fendrick AM, Howden CW. Primary-care physicians' perceptions and practices on the management of GERD: results of a national survey. Am J Gastroenterol. 2005 Jun;100(6):1237-42. doi: 10.1111/j.1572-0241.2005.41364.x.

Reference Type: RESULT

PMID: 15929751 (View on PubMed)

Inadomi JM, Jamal R, Murata GH, Hoffman RM, Lavezo LA, Vigil JM, Swanson KM, Sonnenberg A. Step-down management of gastroesophageal reflux disease. Gastroenterology. 2001 Nov;121(5):1095-100. doi: 10.1053/gast.2001.28649.

Reference Type: RESULT

PMID: 11677201 (View on PubMed)

Inadomi JM, McIntyre L, Bernard L, Fendrick AM. Step-down from multiple- to single-dose proton pump inhibitors (PPIs): a prospective study of patients with heartburn or acid regurgitation completely relieved with PPIs. Am J Gastroenterol. 2003 Sep;98(9):1940-4. doi: 10.1111/j.1572-0241.2003.07665.x.

Reference Type: RESULT

PMID: 14499769 (View on PubMed)

Inadomi JM. Update on the cost-effectiveness of screening for colorectal neoplasia. Curr Opin Gastroenterol. 2003 Jan;19(1):44-50. doi: 10.1097/00001574-200301000-00008.

Reference Type: RESULT

PMID: 15699893 (View on PubMed)

Inadomi JM. On-demand and intermittent therapy for gastro-oesophageal reflux disease: economic considerations. Pharmacoeconomics. 2002;20(9):565-76. doi: 10.2165/00019053-200220090-00001.

Reference Type: RESULT

PMID: 12141885 (View on PubMed)

Inadomi JM, Sampliner R, Lagergren J, Lieberman D, Fendrick AM, Vakil N. Screening and surveillance for Barrett esophagus in high-risk groups: a cost-utility analysis. Ann Intern Med. 2003 Feb 4;138(3):176-86. doi: 10.7326/0003-4819-138-3-200302040-00009.

Reference Type: RESULT

PMID: 12558356 (View on PubMed)

Inadomi JM. Cost-effectiveness of colorectal cancer surveillance in ulcerative colitis. Scand J Gastroenterol Suppl. 2003;(237):17-21. doi: 10.1080/00855910310001430.

Reference Type: RESULT

PMID: 12797675 (View on PubMed)

Inadomi JM, Fendrick AM. PPI use in the OTC era: who to treat, with what, and for how long? Clin Gastroenterol Hepatol. 2005 Mar;3(3):208-15. doi: 10.1016/s1542-3565(04)00717-7.

Reference Type: RESULT

PMID: 15765438 (View on PubMed)

Inadomi J, Fendrick AM. Dyspepsia: Physicians Information and Education Resource. PIER. 2003 Jan 1.

Reference Type: RESULT

Cram P, Fendrick AM, Inadomi J, Cowen ME, Carpenter D, Vijan S. The impact of a celebrity promotional campaign on the use of colon cancer screening: the Katie Couric effect. Arch Intern Med. 2003 Jul 14;163(13):1601-5. doi: 10.1001/archinte.163.13.1601.

Reference Type: RESULT

PMID: 12860585 (View on PubMed)

Other Identifiers

IIR 99-238

Identifier Type: -

Identifier Source: org_study_id