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
|Condition or disease||Intervention/treatment||Phase|
|Proton Pump Inhibitors||Behavioral: PPI De-prescribing Program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||185000 participants|
|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|
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.
- PPI Prescribing (H1) [ Time Frame: 12 months ]The proportion of days proton pump inhibitors are prescribed in the 12 months following the index visit.
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
|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|
|Principal Investigator:||Sameer D. Saini, MD MS||VA Ann Arbor Healthcare System, Ann Arbor, MI|