Ignite Creation Date:
2024-05-06 @ 12:14 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03719170
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2018-10-23
Brief Title:
Evaluation of the National Randomized Proton Pump Inhibitor De-prescribing RaPPID Program
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Evaluation of the National Randomized Proton Pump Inhibitor De-prescribing RaPPID Program
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RaPPID
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 ie 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 VAs 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 eg 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None