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

April 11, 2024 updated by: VA Office of Research and Development
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Proton pump inhibitors (PPIs) are among the most commonly prescribed medications in the Veterans Health Administration (VHA), accounting for over 11 million 30-day prescriptions and nearly $50 million in medication costs annually. Though effective for treatment of acid-related disorders such as gastroesophageal reflux disease, PPIs have been associated with a number of potential harms in observational studies (e.g., dementia, chronic kidney disease, fractures), and increased mortality in Veterans. Nonetheless, PPIs continue to be used without an appropriate indication or for longer and at higher doses than necessary. Accordingly, VHA Pharmacy Benefits Management Services (PBM) will deploy RaPPID - a national Randomized PPI De-prescribing program - in Fiscal Year 2018 targeting patients for whom a short course of PPI is likely sufficient. This program will comprise activation of Clinical Pharmacy Specialists, provider education and academic detailing, and patient education. In partnership with PBM, the investigators propose to conduct an evaluation of this national program in a cluster-randomized design.

Objectives: (1) assess the impact of the de-prescribing program on important clinical outcomes, and to understand how and why these outcomes were achieved or not achieved (outcomes and process evaluation); (2) assess the economic effects of the de-prescribing program (economic evaluation).

Methods: The investigators will then assess the impact of RaPPID on PPI use (primary outcome) in a cluster randomized design (cluster = Veterans Integrated Service Network (VISN). The investigators will also assess a variety of unintended effects, including impact of reduced PPI use on upper GI symptoms and complications such as upper GI bleeding. Furthermore, the investigators will use process evaluation approaches to understand why and how the program was effective or ineffective in specific contexts. Finally, the investigators will use data from the outcomes evaluation of this proposal to estimate the budget impact of RaPPID, taking into account the impact of the program on VHA and non-VHA healthcare utilization.

Impact: RaPPID will be among the largest concerted efforts at de-prescribing ever undertaken in VHA. Prospective evaluation of the program therefore presents a unique opportunity not only to enhance the program itself, but also to gain insights about how to reduce the use of low-value services more broadly, a key VHA priority for the coming decade. Importantly, the prospective, controlled study design the investigators propose will also allow us to make strong claims about whether PPIs cause the putative adverse effects to which they have been linked. Ultimately, this evaluation will provide not only valuable insight into the benefits and harms of a national effort to appropriately de-prescribe PPIs, but also broader lessons about how to effectively undertake other such interventions to de-implement entrenched clinical practices in the future.

Study Type

Interventional

Enrollment (Actual)

220306

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • VA Ann Arbor Healthcare System, Ann Arbor, MI
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • VA Salt Lake City Health Care System, Salt Lake City, UT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

  1. Once-daily PPI with

    • No clear indication for PPIs, OR
    • Uncomplicated Gastroesophageal reflux disease (GERD) OR
  2. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: De-prescribing Program

The 9 Veterans Integrated Service Networks (VISNs) randomly assigned to the PPI de-prescribing program. VISNs are the 18 geographical regions that make up the VHA.

PPI De-prescribing Program: The PPI de-prescribing program included alerts to clinical pharmacy specialists and primary care providers informing them of individual patients scheduled for upcoming primary care visits who meet criteria for PPI de-prescription; activation of clinical pharmacy specialists; education of primary care providers; and patient education.
Behavioral: PPI De-prescribing Program
The PPI de-prescribing program includes alerts to clinical pharmacy specialists and primary care providers informing them of individual patients scheduled for upcoming primary care visits who meet criteria for PPI de-prescription; activation of clinical pharmacy specialists; education of primary care providers; and patient education.
Other Names:
  • RaPPID
No Intervention: No De-prescribing Program
The 8 Veterans Integrated Service Networks (VISNs) randomly assigned to usual care and did not receive the national de-prescribing program. VISNs are the 19 geographical regions that make up the VHA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPI Prescribing (H1)
Time Frame: 12 months
The proportion of days proton pump inhibitors are prescribed in the 12 months following the index visit.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

VHA Pharmacy Benefits Management Services VA Center For Medication Safety

Investigators

  • Principal Investigator: Sameer D. Saini, MD MS, VA Ann Arbor Healthcare System, Ann Arbor, MI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2019

Primary Completion (Actual)

September 15, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

October 23, 2018

First Submitted That Met QC Criteria

October 23, 2018

First Posted (Actual)

October 25, 2018

Study Record Updates

Last Update Posted (Actual)

July 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SDR 18-151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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