Proton Pump InhibitorsRaPPIDNCT03719170
Evaluation of the National Randomized Proton Pump Inhibitor De-prescribing (RaPPID) Program
A study testing PPI De-prescribing Program in people with Proton Pump Inhibitors, run by VA Office of Research and Development at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proton Pump Inhibitors
- What is being tested?
- PPI De-prescribing Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220,306 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Sep 2019to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516
About this study
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.
Read the 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.
- Conditions
- Proton Pump Inhibitors
- Being tested
- PPI De-prescribing Program
- Keywords
- proton pump inhibitors, program evaluation, low-value care, de-implementation, patient safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPI De-prescribing ProgramBehavioural
Also called RaPPID
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPI Prescribing (H1)
The proportion of days proton pump inhibitors are prescribed in the 12 months following the index visit.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start16 Sep 2019
- Primary completion15 Sep 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Proton Pump InhibitorsStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A cluster-randomized (by Veterans Integrated Service Networks or VISN) pragmatic trial of the provider-centered intervention versus pragmatic control.
- Masking
- None (open label)
- Enrolment
- 220,306 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sameer D. Saini, MD MS, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719170
- Sponsor's protocol ID
- SDR 18-151
- Acronym
- RaPPID
- Status last verified
- Apr 2024
- First submitted
- 23 Oct 2018
- Last updated
- 15 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31618539Kurlander 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.
PubMed 32091419Simonov 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.
PubMed 32147588Laine 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.
PubMed 31730767Barkun 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.
PubMed 31634917Saffouri 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.
PubMed 31642558Laine 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.
PubMed 32242363Lee 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.
PubMed 31972617Campbell 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.
PubMed 32144599Shung 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.
PubMed 32530828Laursen 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.
PubMed 32723845Kelly 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.
PubMed 32841646Vyas 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.
PubMed 32941964Kurlander 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.
PubMed 33982954Targownik 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.
PubMed 35183361
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the National Randomized Proton Pump Inhibitor De-prescribing (RaPPID) Program
- ClinicalTrials.gov ID
- NCT03719170
- Acronym / sponsor ID
- RaPPID / SDR 18-151
- Conditions
- Proton Pump Inhibitors
- Keywords
- proton pump inhibitors, program evaluation, low-value care, de-implementation, patient safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220,306 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Posted 15 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cluster-randomized (by Veterans Integrated Service Networks or VISN) pragmatic trial of the provider-centered intervention versus pragmatic control.
| Arm | Type | Receives |
|---|---|---|
| De-prescribing Program | Experimental | Behavioral: PPI De-prescribing ProgramThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Twice-daily PPI for any indication except Zollinger-Ellison
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPI De-prescribing ProgramAlso: RaPPIDThe 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. | Behavioural | De-prescribing Program |
Primary outcome
PPI Prescribing (H1)
Time frame: 12 months
The proportion of days proton pump inhibitors are prescribed in the 12 months following the index visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31618539Spechler 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.
- Results publication: PubMed 32091419Kurlander 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.
- Results publication: PubMed 32147588Simonov 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.
- Results publication: PubMed 31730767Laine 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.
- Results publication: PubMed 31634917Barkun 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.
- Results publication: PubMed 31642558Saffouri 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.
- Results publication: PubMed 32242363Laine 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.
- Results publication: PubMed 31972617Lee 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.
- Results publication: PubMed 32144599Campbell 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.
- Results publication: PubMed 32530828Shung 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.
- Results publication: PubMed 32723845Laursen 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.
- Results publication: PubMed 32841646Kelly 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameer D. Saini, MD MS principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPI De-prescribing Program in people with Proton Pump Inhibitors, run by VA Office of Research and Development at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPI Prescribing (H1) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03719170, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.