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

NCT03719170 | Completed Results

• 1 other identifier: SDR 18-151
• Study Type: interventional
• Target: 220,306
• Locations: 1 country
• Sites: 4

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.

Conditions

Proton Pump Inhibitors

Keywords

proton pump inhibitors; program evaluation; low-value care; de-implementation; patient safety

Outcome Measures

Primary Outcomes (1)

• PPI Prescribing (H1)

  The proportion of days proton pump inhibitors are prescribed in the 12 months following the index visit.

  12 months

Study Arms (2)

De-prescribing Program

EXPERIMENTAL

The 9 Veterans Integrated Service Networks (VISNs) randomly assigned to the PPI de-prescribing program. VISNs are the 18 geographical regions that make up the VHA. PPI De-prescribing Program: The PPI de-prescribing program included 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.

Behavioral: PPI De-prescribing Program

No De-prescribing Program

NO INTERVENTION

The 8 Veterans Integrated Service Networks (VISNs) randomly assigned to usual care and did not receive the national de-prescribing program. VISNs are the 19 geographical regions that make up the VHA.

Interventions

PPI De-prescribing Program BEHAVIORAL

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.

Also known as: RaPPID

De-prescribing Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic PPI users defined as 90-day prescription during the 120-day period prior to a scheduled VA primary care visit who receive:
• Once-daily PPI with
• No clear indication for PPIs, OR
• Uncomplicated Gastroesophageal reflux disease (GERD) OR
• Twice-daily PPI for any indication except Zollinger-Ellison

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148, United States

Location

Related Publications (15)

• 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. N Engl J Med. 2019 Oct 17;381(16):1513-1523. doi: 10.1056/NEJMoa1811424.

  PMID: 31618539 RESULT

• 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. 2020 May;115(5):689-696. doi: 10.14309/ajg.0000000000000558.

  PMID: 32091419 RESULT

• 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 Mar 6.

  PMID: 32147588 RESULT

• 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. No abstract available.

  PMID: 31730767 RESULT

• 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. Ann Intern Med. 2019 Dec 3;171(11):805-822. doi: 10.7326/M19-1795. Epub 2019 Oct 22.

  PMID: 31634917 RESULT

• 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: 10.1111/apt.15541. Epub 2019 Oct 23.

  PMID: 31642558 RESULT

• 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. No abstract available.

  PMID: 32242363 RESULT

• 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.

  PMID: 31972617 RESULT

• 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.

  PMID: 32144599 RESULT

• 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.

  PMID: 32530828 RESULT

• 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;70(4):707-716. doi: 10.1136/gutjnl-2019-320002. Epub 2020 Jul 28.

  PMID: 32723845 RESULT

• 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. No abstract available.

  PMID: 32841646 RESULT

• 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. Hum Pathol. 2020 Nov;105:67-73. doi: 10.1016/j.humpath.2020.08.007. Epub 2020 Sep 14.

  PMID: 32941964 RESULT

• 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):821-824. doi: 10.14309/ajg.0000000000001134.

  PMID: 33982954 RESULT

• Targownik LE, Fisher DA, Saini SD. AGA Clinical Practice Update on De-Prescribing of Proton Pump Inhibitors: Expert Review. Gastroenterology. 2022 Apr;162(4):1334-1342. doi: 10.1053/j.gastro.2021.12.247. Epub 2022 Feb 17.

  PMID: 35183361 RESULT

Limitations and Caveats

The following issues likely contributed to decreased implementation of intervention: 1. Ranitidine was a key "step down" medication to use in place of PPIs, but a national shortage disrupted its availability; and, 2. COVID-19 pandemic 6 months into intervention.

Results Point of Contact

• Title: Dr. Sameer Saini
• Organization: VA Ann Arbor Healthcare System

sameer.saini@va.gov

734-845-3504

Study Officials

• Sameer D. Saini, MD MS

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: A cluster-randomized (by Veterans Integrated Service Networks or VISN) pragmatic trial of the provider-centered intervention versus pragmatic control.

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 25, 2018
• Study Start: September 16, 2019
• Primary Completion: September 15, 2021
• Study Completion: November 30, 2021
• Last Updated: July 15, 2024
• Results First Posted: July 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)