Evaluation of the National Randomized Proton Pump Inhibitor De-prescribing (RaPPID) Program

Proton Pump Inhibitors Clinical Trial

— RaPPID  

Official title:

Evaluation of the National Randomized Proton Pump Inhibitor De-prescribing (RaPPID) Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03719170
• Other study ID #: SDR 18-151
• Status: Completed
• Phase: N/A
• Start date: September 16, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: March 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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) 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208266
• Est. completion date: November 30, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Proton Pump Inhibitors

Intervention

Behavioral:
• PPI De-prescribing Program
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.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan
United States	Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA	Philadelphia	Pennsylvania
United States	VA Salt Lake City Health Care System, Salt Lake City, UT	Salt Lake City	Utah
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	VHA Pharmacy Benefits Management Services VA Center For Medication Safety

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

Campbell EV 3rd, Muniraj T, Aslanian HR, Laine L, Jamidar P. Musculoskeletal Pain Symptoms and Injuries Among Endoscopists Who Perform ERCP. Dig Dis Sci. 2021 Jan;66(1):56-62. doi: 10.1007/s10620-020-06163-z. Epub 2020 Mar 6. — View Citation

Kelly CR, Laine LA, Wu GD. Monitoring Fecal Microbiota Transplantation Practice in a Rapidly Evolving Health and Regulatory Environment. Gastroenterology. 2020 Dec;159(6):2004-2006. doi: 10.1053/j.gastro.2020.08.039. Epub 2020 Aug 22. — View Citation

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. Am J Gastroenterol. 2021 Apr;116(4):8 — View Citation

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. Am J Gastroenterol. — View Citation

Laine L. Colonoscopy for Lower Gastrointestinal Bleeding-Time Is Not of the Essence. Gastroenterology. 2020 Jan;158(1):38-39. doi: 10.1053/j.gastro.2019.11.009. Epub 2019 Nov 12. — View Citation

Laine L. Timing of Endoscopy in Patients Hospitalized with Upper Gastrointestinal Bleeding. N Engl J Med. 2020 Apr 2;382(14):1361-1363. doi: 10.1056/NEJMe2002121. — View Citation

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 gastrointesti — View Citation

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. Am J Gastroenterol. 2020 May;115(5):662-670. doi: 10.14309/ajg.0000000000000495. — View Citation

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. Aliment Pharmacol Ther. 2020 Jan;51(2):253-260. doi: 1 — View Citation

Shung D, Laine L. Machine Learning Prognostic Models for Gastrointestinal Bleeding Using Electronic Health Record Data. Am J Gastroenterol. 2020 Aug;115(8):1199-1200. doi: 10.14309/ajg.0000000000000720. — View Citation

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. Clin Gastroenterol Hepatol. 2021 Jan;19(1):72-79.e21. doi: 10.1016/j.cgh.2020.02.053. Epub 2020 M — View Citation

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 — View Citation

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 gastro — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PPI Prescribing (H1)	The proportion of days proton pump inhibitors are prescribed in the 12 months following the index visit.	12 months