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SDR 18-151 – HSR Study

SDR 18-151
Evaluation of the National Randomized Proton Pump Inhibitor De-prescribing (RaPPID) Program
Sameer D. Saini, MD MS
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, MI
Funding Period: January 2018 - October 2021
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, we propose to conduct an evaluation of this national program in a cluster-randomized design.

The objectives of this study are to: (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).

Prior to national randomization and deployment, we will identify barriers and facilitators to uptake of RaPPID through Veteran and provider interviews. We will then assess the impact of RaPPID on PPI use (primary outcome) in a cluster randomized design (cluster = healthcare system) through administrative data. We 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 through longitudinal surveys with Veterans. Furthermore, we will use process evaluation approaches, including staff and Veteran interviews and surveying pharmacists, to understand why and how the program was effective or ineffective in specific contexts. Finally, we 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.

Anticipated Findings:
The primary outcome will be proportion of days PPIs are prescribed at or above the baseline daily dosing-frequency, over the 12 months following the index visit. We hypothesize (H1) that the proportion of days will be lower in intervention group than in the control group (i.e., that the outcome will be superior in the intervention vs control group).

We will also measure a variety of secondary outcomes to assess unintended, adverse events related to PPI de-prescribing. We hypothesize that utilization of outpatient care (H2) and upper GI symptoms (H3) will be non-inferior in the intervention vs control group.

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 we 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.

External Links for this Project

NIH Reporter

Grant Number: I01HX002693-01

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Journal Articles

  1. Laursen SB, Oakland K, Laine L, Bieber V, Marmo R, Redondo-Cerezo E, Dalton HR, Ngu J, Schultz M, Soncini M, Gralnek I, Jairath V, Murray IA, Stanley AJ. ABC score: a new risk score that accurately predicts mortality in acute upper and lower gastrointestinal bleeding: an international multicentre study. Gut. 2021 Apr 1; 70(4):707-716. [view]
  2. Targownik LE, Fisher DA, Saini SD. AGA Clinical Practice Update on De-Prescribing of Proton Pump Inhibitors: Expert Review. Gastroenterology. 2022 Apr 1; 162(4):1334-1342. [view]
  3. Vyas M, Celli R, Singh M, Patel N, Aslanian HR, Boffa D, Deng Y, Ciarleglio MM, Laine L, Jain D. Intestinal metaplasia around the gastroesophageal junction is frequently associated with antral reactive gastropathy: implications for carcinoma at the gastroesophageal junction. Human Pathology. 2020 Nov 1; 105:67-73. [view]
  4. Barkun AN, Almadi M, Kuipers EJ, Laine L, Sung J, Tse F, Leontiadis GI, Abraham NS, Calvet X, Chan FKL, Douketis J, Enns R, Gralnek IM, Jairath V, Jensen D, Lau J, Lip GYH, Loffroy R, Maluf-Filho F, Meltzer AC, Reddy N, Saltzman JR, Marshall JK, Bardou M. Management of Nonvariceal Upper Gastrointestinal Bleeding: Guideline Recommendations From the International Consensus Group. Annals of internal medicine. 2019 Dec 3; 171(11):805-822. [view]
  5. Campbell EV, Muniraj T, Aslanian HR, Laine L, Jamidar P. Musculoskeletal Pain Symptoms and Injuries Among Endoscopists Who Perform ERCP. Digestive diseases and sciences. 2021 Jan 1; 66(1):56-62. [view]
  6. Kurlander JE, Rubenstein JH, Richardson CR, Krein SL, De Vries R, Zikmund-Fisher BJ, Yang YX, Laine L, Weissman A, Saini SD. Physicians' Perceptions of Proton Pump Inhibitor Risks and Recommendations to Discontinue: A National Survey. The American journal of gastroenterology. 2020 May 1; 115(5):689-696. [view]
  7. Spechler SJ, Hunter JG, Jones KM, Lee R, Smith BR, Mashimo H, Sanchez VM, Dunbar KB, Pham TH, Murthy UK, Kim T, Jackson CS, Wallen JM, von Rosenvinge EC, Pearl JP, Laine L, Kim AW, Kaz AM, Tatum RP, Gellad ZF, Lagoo-Deenadayalan S, Rubenstein JH, Ghaferi AA, Lo WK, Fernando RS, Chan BS, Paski SC, Provenzale D, Castell DO, Lieberman D, Souza RF, Chey WD, Warren SR, Davis-Karim A, Melton SD, Genta RM, Serpi T, Biswas K, Huang GD. Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn. The New England journal of medicine. 2019 Oct 17; 381(16):1513-1523. [view]
  8. Saffouri E, Blackwell C, Laursen SB, Laine L, Dalton HR, Ngu J, Shultz M, Norton R, Stanley AJ. The Shock Index is not accurate at predicting outcomes in patients with upper gastrointestinal bleeding. Alimentary pharmacology & therapeutics. 2020 Jan 1; 51(2):253-260. [view]
  9. Kurlander JE, Barnes GD, Sukul D, Helminski D, Kokaly AN, Platt K, Gurm H, Saini SD. Trials of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention Lack Strategies to Ensure Appropriate Gastroprotection. The American journal of gastroenterology. 2021 Apr 1; 116(4):821-824. [view]
  10. Lee MW, Pourmorady JS, Laine L. Use of Fecal Occult Blood Testing as a Diagnostic Tool for Clinical Indications: A Systematic Review and Meta-Analysis. The American journal of gastroenterology. 2020 May 1; 115(5):662-670. [view]
  11. Simonov M, Abel EA, Skanderson M, Masoud A, Hauser RG, Brandt CA, Wilson FP, Laine L. Use of Proton Pump Inhibitors Increases Risk of Incident Kidney Stones. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 2021 Jan 1; 19(1):72-79.e21. [view]
Journal Other

  1. Laine L. Colonoscopy for Lower Gastrointestinal Bleeding-Time Is Not of the Essence. [Editorial]. Gastroenterology. 2020 Jan 1; 158(1):38-39. [view]
  2. Shung D, Laine L. Machine Learning Prognostic Models for Gastrointestinal Bleeding Using Electronic Health Record Data. The American journal of gastroenterology. 2020 Aug 1; 115(8):1199-1200. [view]
  3. Kelly CR, Laine LA, Wu GD. Monitoring Fecal Microbiota Transplantation Practice in a Rapidly Evolving Health and Regulatory Environment. [Editorial]. Gastroenterology. 2020 Dec 1; 159(6):2004-2006. [view]
  4. Laine L. Timing of Endoscopy in Patients Hospitalized with Upper Gastrointestinal Bleeding. [Editorial]. The New England journal of medicine. 2020 Apr 2; 382(14):1361-1363. [view]

DRA: Digestive Diseases
DRE: Prevention, Treatment - Implementation, TRL - Applied/Translational
Keywords: Decision-Making
MeSH Terms: none

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