Mode
Text Size
Log in / Sign up
N/A N=220,306 Randomized Health Services Research

Evaluation of the National Randomized Proton Pump Inhibitor De-prescribing (RaPPID) Program

Proton Pump Inhibitors

Enrolled (actual)
220,306
Serious AEs
Results posted
Jul 2024
Primary outcome: Primary: PPI Prescribing (H1) — 73.69; 72.66 percentage of days on PPI

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
PPI De-prescribing Program (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Sep 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
PPI Prescribing (H1)
73.69; 72.66

Summary

Proton pump inhibitors (PPIs) are medications used to treat acid-related stomach disorders, such as chronic heartburn. These medications are widely used by Veterans, with over 11 million 30-day prescriptions being filled each year. Though they are highly effective, long-term use of PPIs may be harmful. For this reason, experts recommend that PPIs be stopped in patients who do not have a clear need for these medications. Unfortunately, PPIs continue to be overused. To address this issue, the VA is implementing a national program to de-prescribe (i.e., reduce the dose of, or stop) PPIs. In this study, the investigators will be evaluating this national program by assessing: (a) how successfully the program was implemented; (b) understanding how effective the program was in improving appropriate use of PPIs; and, (c) ensuring no unintended consequences (such as peptic ulcer bleeding) occurred with PPI de-prescribing. This study addresses a potential safety concern for Veterans and aligns with VA's broader goal of de-implementing low-value care.

Eligibility Criteria

Inclusion Criteria

Chronic PPI users defined as 90-day prescription during the 120-day period prior to a scheduled VA primary care visit who receive:

  • Once-daily PPI with
  • No clear indication for PPIs, OR
  • Uncomplicated Gastroesophageal reflux disease (GERD) OR
  • Twice-daily PPI for any indication except Zollinger-Ellison

Exclusion Criteria

Patients taking once-daily PPIs will be excluded if they have one or more of the following characteristics:

  • Eosinophilic esophagitis
  • Esophagitis
  • Esophageal ulcer
  • Esophageal stenosis/stricture
  • Dysphagia (other than oropharyngeal)
  • Barrett's esophagus
  • Peptic ulcer
  • Zollinger-Ellison
  • Idiopathic pulmonary fibrosis
  • NSAID + age > 65 yrs, 2nd NSAID, aspirin, anti-thrombotic, OR corticosteroid
  • Aspirin + age 60 yrs, NSAID, anti-thrombotic, OR corticosteroid
  • Pancreatic enzyme replacement
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03719170). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search