An interventional study of PPI De-prescribing Program in Proton Pump Inhibitors, sponsored by VA Office of Research and Development. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-15.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research
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.
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.
VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Patients taking once-daily PPIs will be excluded if they have one or more of the following characteristics:
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 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.
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.
Also known as: RaPPID
PPI Prescribing (H1)
The proportion of days proton pump inhibitors are prescribed in the 12 months following the index visit.
Time frame: 12 months
This was a national Veterans Health Administration (VHA) program. Randomization was at the level of geographical regions called Veterans Integrated Service Networks (VISNs). At the date of randomization (8/27/2019), there were 18 VISNs. One VISN was excluded because it was the model for the national program. Out of 17 VISNs, 8 were randomized to the control arm and 9 to the intervention arm. Subjects were identified via an electronic algorithm during the recruitment year 9/16/2019 - 9/15/2020.
| Milestone | De-prescribing Program | No De-prescribing Program |
|---|---|---|
| Started | 119494 | 100812 |
| Completed | 119494 | 100812 |
| Not completed | 0 | 0 |
The proportion of days proton pump inhibitors are prescribed in the 12 months following the index visit.
| percentage of days on PPI | De-prescribing Program | No De-prescribing Program |
|---|---|---|
| PPI Prescribing (H1) | 73.69 ± 0.27 | 72.66 ± 0.27 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| De-prescribing Program | — | — | — |
| No De-prescribing Program | — | — | — |
| Age, Continuous(years) | De-prescribing Program | No De-prescribing Program | Total |
|---|---|---|---|
| Mean | 64.74 ± 13.00 | 64.63 ± 13.19 | 64.69 ± 13.09 |
| Sex: Female, Male(Participants) | De-prescribing Program | No De-prescribing Program | Total |
|---|---|---|---|
| Sex — Female | 8,101 | 7,036 | 15137 |
| Sex — Male | 111,389 | 93,770 | 205159 |
| Ethnicity (NIH/OMB)(Participants) | De-prescribing Program | No De-prescribing Program | Total |
|---|---|---|---|
| Hispanic or Latino | 2,624 | 7,757 | 10381 |
| Not Hispanic or Latino | 116,866 | 93,049 | 209915 |
| Unknown or Not Reported | 4 | 6 | 10 |
| Race (NIH/OMB)(Participants) | De-prescribing Program | No De-prescribing Program | Total |
|---|---|---|---|
| American Indian or Alaska Native | 825 | 785 | 1610 |
| Asian | 716 | 547 | 1263 |
| Native Hawaiian or Other Pacific Islander | 816 | 669 | 1485 |
| Black or African American | 16,964 | 13,948 | 30912 |
| White | 93,976 | 79,990 | 173966 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 6,197 | 4,873 | 11070 |
| Charlson Comorbidity Index (CCI)(Participants) | De-prescribing Program | No De-prescribing Program | Total |
|---|---|---|---|
| Charlson Comorbidity Index = 0 | 44,970 | 37,710 | 82680 |
| Charlson Comorbidity Index = 1 | 30,391 | 24,781 | 55172 |
| Charlson Comorbidity Score = 2 | 14,889 | 12,598 | 27487 |
| Charlson Comorbidity Index = 3 | 11,982 | 10,312 | 22294 |
| Charlson Comorbidity Index = 4 | 6,329 | 5,412 | 11741 |
| Charlson Comorbidity Index >= 5 | 10,933 | 9,999 | 20932 |
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