Clinical trial NCT03719170: Evaluation of the National Randomized Proton Pump Inhibitor De-prescribing (RaPPID) Program
Official title: Evaluation of the National Randomized Proton Pump Inhibitor De-prescribing (RaPPID) Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proton Pump Inhibitors
Keywords: proton pump inhibitors
program evaluation
low-value care
de-implementation
patient safety
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-10-25
Enrollment: 220306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster-randomized (by Veterans Integrated Service Networks or VISN) pragmatic trial of the provider-centered intervention versus pragmatic control.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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 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

Primary outcomes:
measure: PPI Prescribing (H1)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
state: Pennsylvania
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System, Salt Lake City, UT
state: Utah
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Sameer D. Saini, MD MS
role: PRINCIPAL_INVESTIGATOR
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