Evaluation of the National Randomized Proton Pump Inhibitor De-prescribing (RaPPID) Program
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/13/2019 |
| Start Date: | August 1, 2019 |
| End Date: | October 31, 2021 |
| Contact: | Darcy Saffar, MPH BS |
| Email: | darcy.saffar@va.gov |
| Phone: | (734) 845-4395 |
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.
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 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) identify system-, provider-, and patient-level barriers and facilitators to
PPI de-prescribing (formative evaluation); (2) 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); (3) assess the economic effects
of the de-prescribing program (economic evaluation).
Methods: Using formative evaluation approaches, the investigators will first identify
barriers and facilitators to uptake of RaPPID, prior to national randomization and
deployment. The investigators will then assess the impact of RaPPID on PPI use (primary
outcome) in a cluster randomized design (cluster = healthcare system). 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.
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) identify system-, provider-, and patient-level barriers and facilitators to
PPI de-prescribing (formative evaluation); (2) 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); (3) assess the economic effects
of the de-prescribing program (economic evaluation).
Methods: Using formative evaluation approaches, the investigators will first identify
barriers and facilitators to uptake of RaPPID, prior to national randomization and
deployment. The investigators will then assess the impact of RaPPID on PPI use (primary
outcome) in a cluster randomized design (cluster = healthcare system). 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.
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
We found this trial at
4
sites
Salt Lake City, Utah 84148
Phone: 801-582-1565
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Ann Arbor, Michigan 48113
Principal Investigator: Sameer D. Saini, MD MS
Phone: 734-845-4395
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3900 Woodland Avenue
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Phone: 215-823-5800
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West Haven, Connecticut 06516
Phone: 203-932-5711
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