DepRescribing inapprOpriate Proton Pump InhibiTors (DROPIT): study protocol of a cluster-randomised controlled trial in Swiss primary care

Objectives Proton pump inhibitors (PPIs) are widely prescribed medications and commonly used for the treatment of gastric acid-related disorders. Nevertheless, PPIs are often overused leading to potential adverse effects and unnecessary healthcare costs. Deprescribing strategies have emerged to safe...

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Main Authors: Stefan Neuner-Jehle, Katharina Tabea Jungo, Sven Streit, Sven Trelle, Nicolas Rodondi, Carole Elodie Aubert, Kristie Rebecca Weir, Enriqueta Vallejo-Yagüe, Samantha Chan, Marie Roumet, Pascal Juillerat, Sofia Carolina Zambrano Ramos, Jennifer Inauen, Angela Edith Schulthess-Lisibach, Renata Vidonscky Lüthold, Clémentine Tombez, Martina Zangger, Flurina Jenal, Yvonne Mattmann, Christof Bieri, Michaela Barbier
Format: Article
Language:English
Published: BMJ Publishing Group 2025-01-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/1/e094495.full
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author Stefan Neuner-Jehle
Katharina Tabea Jungo
Sven Streit
Sven Trelle
Nicolas Rodondi
Carole Elodie Aubert
Kristie Rebecca Weir
Enriqueta Vallejo-Yagüe
Samantha Chan
Marie Roumet
Pascal Juillerat
Sofia Carolina Zambrano Ramos
Jennifer Inauen
Angela Edith Schulthess-Lisibach
Renata Vidonscky Lüthold
Clémentine Tombez
Martina Zangger
Flurina Jenal
Yvonne Mattmann
Christof Bieri
Michaela Barbier
author_facet Stefan Neuner-Jehle
Katharina Tabea Jungo
Sven Streit
Sven Trelle
Nicolas Rodondi
Carole Elodie Aubert
Kristie Rebecca Weir
Enriqueta Vallejo-Yagüe
Samantha Chan
Marie Roumet
Pascal Juillerat
Sofia Carolina Zambrano Ramos
Jennifer Inauen
Angela Edith Schulthess-Lisibach
Renata Vidonscky Lüthold
Clémentine Tombez
Martina Zangger
Flurina Jenal
Yvonne Mattmann
Christof Bieri
Michaela Barbier
author_sort Stefan Neuner-Jehle
collection DOAJ
description Objectives Proton pump inhibitors (PPIs) are widely prescribed medications and commonly used for the treatment of gastric acid-related disorders. Nevertheless, PPIs are often overused leading to potential adverse effects and unnecessary healthcare costs. Deprescribing strategies have emerged to safely reduce or substitute inappropriate PPIs and optimise patient care in an evidence-based manner. This protocol describes a study to evaluate the effectiveness of a PPI deprescribing intervention in comparison to usual care in the Swiss primary care setting.Design An open-label, cluster randomised controlled trial.Setting Swiss primary care settings.Participants Included participants will be adults with inappropriate PPI treatment and will be recruited by general practitioners (GPs). Participants treated by the same GP constitute a cluster. Clusters are randomised 1:1 to either the intervention group or the control group.Interventions The intervention components consist of deprescribing tools including educational material, decision aids for both participants and GPs, and additional trainings for GPs only. Patients in the control group will receive usual care. Data will be collected at baseline, 3-, 6-, 9- and 12-month follow-up time through online surveys or a phone call for both GPs and participants.Primary and secondary outcome measures The first co-primary endpoint is the effectiveness of the deprescribing intervention measured by the change of prescribed PPI dose. The second co-primary endpoint is safety, which is measured with the Reflux Disease Questionnaire assessing change in gastrointestinal symptoms. There are several secondary endpoints, such as the total number of prescribed medications, occurrences of changes in prescription patterns, PPI discontinuation and cost-effectiveness.Conclusions The findings from this study will provide evidence on the effectiveness and safety of a PPI deprescribing intervention for patients and GPs. Successful implementation of our PPI deprescribing strategy has the potential to improve patient outcomes and lower costs.Trial registration number NCT06129474.
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spelling doaj-art-84ef8f9fbdc84d7c913d190983148ccf2025-01-21T11:05:09ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-094495DepRescribing inapprOpriate Proton Pump InhibiTors (DROPIT): study protocol of a cluster-randomised controlled trial in Swiss primary careStefan Neuner-Jehle0Katharina Tabea Jungo1Sven Streit2Sven Trelle3Nicolas Rodondi4Carole Elodie Aubert5Kristie Rebecca Weir6Enriqueta Vallejo-Yagüe7Samantha Chan8Marie Roumet9Pascal Juillerat10Sofia Carolina Zambrano Ramos11Jennifer Inauen12Angela Edith Schulthess-Lisibach13Renata Vidonscky Lüthold14Clémentine Tombez15Martina Zangger16Flurina Jenal17Yvonne Mattmann18Christof Bieri19Michaela Barbier20Center for Primary and Community Care, University of Luzern, Luzern, SwitzerlandInstitute of Primary Health Care (BIHAM), University of Bern, Bern, SwitzerlandInstitute of Primary Health Care (BIHAM), University of Bern, Bern, SwitzerlandDepartment of Clinical Research, University of Bern, Bern, SwitzerlandInstitute of Primary Health Care (BIHAM), University of Bern, Bern, SwitzerlandInstitute of Primary Health Care (BIHAM), University of Bern, Bern, SwitzerlandInstitute of Primary Health Care (BIHAM), University of Bern, Bern, SwitzerlandInstitute of Primary Health Care (BIHAM), University of Bern, Bern, SwitzerlandDepartment of Clinical Research, University of Bern, Bern, SwitzerlandDepartment of Clinical Research, University of Bern, Bern, SwitzerlandGastroenterology, Clinic for Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, SwitzerlandInstitute of Social and Preventive Medicine (ISPM), University of Bern, Bern, SwitzerlandInstitute of Psychology, University of Bern, Bern, SwitzerlandInstitute of Primary Health Care (BIHAM), University of Bern, Bern, SwitzerlandInstitute of Primary Health Care (BIHAM), University of Bern, Bern, SwitzerlandInstitute of Psychology, University of Bern, Bern, SwitzerlandInstitute of Primary Health Care (BIHAM), University of Bern, Bern, SwitzerlandDepartment of Clinical Research, University of Bern, Bern, SwitzerlandInstitute of Social and Preventive Medicine (ISPM), University of Bern, Bern, SwitzerlandInstitute of Primary Health Care (BIHAM), University of Bern, Bern, SwitzerlandHealth Economics Facility, Departement of Public Health, University of Basel, Basel, SwitzerlandObjectives Proton pump inhibitors (PPIs) are widely prescribed medications and commonly used for the treatment of gastric acid-related disorders. Nevertheless, PPIs are often overused leading to potential adverse effects and unnecessary healthcare costs. Deprescribing strategies have emerged to safely reduce or substitute inappropriate PPIs and optimise patient care in an evidence-based manner. This protocol describes a study to evaluate the effectiveness of a PPI deprescribing intervention in comparison to usual care in the Swiss primary care setting.Design An open-label, cluster randomised controlled trial.Setting Swiss primary care settings.Participants Included participants will be adults with inappropriate PPI treatment and will be recruited by general practitioners (GPs). Participants treated by the same GP constitute a cluster. Clusters are randomised 1:1 to either the intervention group or the control group.Interventions The intervention components consist of deprescribing tools including educational material, decision aids for both participants and GPs, and additional trainings for GPs only. Patients in the control group will receive usual care. Data will be collected at baseline, 3-, 6-, 9- and 12-month follow-up time through online surveys or a phone call for both GPs and participants.Primary and secondary outcome measures The first co-primary endpoint is the effectiveness of the deprescribing intervention measured by the change of prescribed PPI dose. The second co-primary endpoint is safety, which is measured with the Reflux Disease Questionnaire assessing change in gastrointestinal symptoms. There are several secondary endpoints, such as the total number of prescribed medications, occurrences of changes in prescription patterns, PPI discontinuation and cost-effectiveness.Conclusions The findings from this study will provide evidence on the effectiveness and safety of a PPI deprescribing intervention for patients and GPs. Successful implementation of our PPI deprescribing strategy has the potential to improve patient outcomes and lower costs.Trial registration number NCT06129474.https://bmjopen.bmj.com/content/15/1/e094495.full
spellingShingle Stefan Neuner-Jehle
Katharina Tabea Jungo
Sven Streit
Sven Trelle
Nicolas Rodondi
Carole Elodie Aubert
Kristie Rebecca Weir
Enriqueta Vallejo-Yagüe
Samantha Chan
Marie Roumet
Pascal Juillerat
Sofia Carolina Zambrano Ramos
Jennifer Inauen
Angela Edith Schulthess-Lisibach
Renata Vidonscky Lüthold
Clémentine Tombez
Martina Zangger
Flurina Jenal
Yvonne Mattmann
Christof Bieri
Michaela Barbier
DepRescribing inapprOpriate Proton Pump InhibiTors (DROPIT): study protocol of a cluster-randomised controlled trial in Swiss primary care
BMJ Open
title DepRescribing inapprOpriate Proton Pump InhibiTors (DROPIT): study protocol of a cluster-randomised controlled trial in Swiss primary care
title_full DepRescribing inapprOpriate Proton Pump InhibiTors (DROPIT): study protocol of a cluster-randomised controlled trial in Swiss primary care
title_fullStr DepRescribing inapprOpriate Proton Pump InhibiTors (DROPIT): study protocol of a cluster-randomised controlled trial in Swiss primary care
title_full_unstemmed DepRescribing inapprOpriate Proton Pump InhibiTors (DROPIT): study protocol of a cluster-randomised controlled trial in Swiss primary care
title_short DepRescribing inapprOpriate Proton Pump InhibiTors (DROPIT): study protocol of a cluster-randomised controlled trial in Swiss primary care
title_sort deprescribing inappropriate proton pump inhibitors dropit study protocol of a cluster randomised controlled trial in swiss primary care
url https://bmjopen.bmj.com/content/15/1/e094495.full
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