N/A
N=220,306
Evaluation of the National Randomized Proton Pump Inhibitor De-prescribing (RaPPID) Program
Proton Pump Inhibitors
Bottom Line
View on ClinicalTrials.gov: NCT03719170 ↗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
| Outcome | Result | p-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
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.