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

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ClinicalTrials.gov Identifier: NCT03719170
Recruitment Status : Active, not recruiting
First Posted : October 25, 2018
Last Update Posted : April 5, 2021
Sponsor:
Collaborators:
VHA Pharmacy Benefits Management Services VA Center For Medication Safety
VA Puget Sound Health Care System
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Proton Pump Inhibitors Behavioral: PPI De-prescribing Program Not Applicable

Detailed Description:

Background: Proton pump inhibitors (PPIs) are among the most commonly prescribed medications in the 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A cluster-randomized (by Veterans Integrated Service Networks or VISN) pragmatic trial of the provider-centered intervention versus pragmatic control.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of the National Randomized Proton Pump Inhibitor De-prescribing (RaPPID) Program
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : October 31, 2021

Arm Intervention/treatment
Experimental: De-prescribing Program
Veterans Integrated Service Networks (VISNs) randomly assigned to the PPI de-prescribing program. VISNs are the 19 geographical regions that make up the VHA.
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 Name: RaPPID

No Intervention: No De-prescribing Program
Veterans Integrated Service Networks (VISNs) randomly assigned to usual care and will not receive the national de-prescribing program. VISNs are the 19 geographical regions that make up the VHA.



Primary Outcome Measures :
  1. PPI Prescribing (H1) [ Time Frame: 12 months ]
    The proportion of days proton pump inhibitors are prescribed in the 12 months following the index visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  1. Once-daily PPI with

    • No clear indication for PPIs, OR
    • Uncomplicated GERD OR
  2. Twice-daily PPI for any indication except Zollinger-Ellison

Exclusion Criteria:

Patients taking once-daily PPIs will be exclued 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719170


Locations
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United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
United States, Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
VA Office of Research and Development
VHA Pharmacy Benefits Management Services VA Center For Medication Safety
VA Puget Sound Health Care System
Investigators
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Principal Investigator: Sameer D. Saini, MD MS VA Ann Arbor Healthcare System, Ann Arbor, MI
Publications of Results:

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03719170    
Other Study ID Numbers: SDR 18-151
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
proton pump inhibitors
program evaluation
low-value care
de-implementation
patient safety