Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057174
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2003-03-27
Brief Title:
Economic Impact of Guidelines for Gastroesophageal Reflux Disease
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Economic Impact of Guidelines for Gastroesophageal Reflux Disease
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None