Implementation of an electronic medication management support system in hospitalised polypharmacy patients: study protocol of a stepped-wedge cluster-randomised controlled trial (TOP study)
Introduction Polypharmacy is associated with an increased risk of adverse patient outcomes across various settings, including inpatient care. To enhance the appropriateness of medication therapy management for patients during hospital stays, computerised interventions have shown promise with regard...
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BMJ Publishing Group
2025-04-01
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| author | Peter Ihle Katrin Christiane Reber Juliane Köberlein-Neu Ingo Meyer Matthias Schilling Daniel Grandt Till Beckmann Lara Düvel Sara Söling Simone Grandt Wolfgang Greiner Sarah Meyer David Lampe Adriana Poppe Raphaele Bartels Christoph Klaas Adda Dumröse Susanne Dolfen Nathalie Sinnen Carolin Polte Olga Resch Nicole Faulenbach Hannah Britz Beate Halex Sofie May Christof Shelian |
| author_facet | Peter Ihle Katrin Christiane Reber Juliane Köberlein-Neu Ingo Meyer Matthias Schilling Daniel Grandt Till Beckmann Lara Düvel Sara Söling Simone Grandt Wolfgang Greiner Sarah Meyer David Lampe Adriana Poppe Raphaele Bartels Christoph Klaas Adda Dumröse Susanne Dolfen Nathalie Sinnen Carolin Polte Olga Resch Nicole Faulenbach Hannah Britz Beate Halex Sofie May Christof Shelian |
| collection | DOAJ |
| description | Introduction Polypharmacy is associated with an increased risk of adverse patient outcomes across various settings, including inpatient care. To enhance the appropriateness of medication therapy management for patients during hospital stays, computerised interventions have shown promise with regard to patient safety. This study assesses whether the implementation of a clinical decision support system will optimise the process of inpatient medication therapy to prevent inappropriate medication use and thus promote patient safety.Methods and analysis The intervention will be evaluated in a prospective, cluster-randomised controlled trial using a stepped-wedge design. The study will be conducted in 12 hospitals across Germany over a total period of 33 months. Patients will be treated according to the group status of the hospital and receive either standard care or the Transsektorale Optimierung der Patientensicherheit or trans-sectoral optimisation of patient safety intervention. The primary outcome is the combined endpoint of all-cause mortality and all-cause hospitalisation. Secondary endpoints are, for example, inappropriate prescriptions, utilisation of different health services, cost-effectiveness, as well as patient-reported outcome measures. Parameters describing the attitudes of patients and healthcare professionals towards the intervention and organisational change processes will be collected as part of the process evaluation. The primary endpoint will be evaluated using hospital and outpatient claims data from participating statutory health insurances at the population level. There are multiple secondary endpoints with data linkage of primary and secondary data at study participant level. Statistical analysis will make use of (generalised) linear mixed models or generalised estimating equations, taking account of independent covariables. All data analyses of the process evaluation will be descriptive and explorative.Ethics and dissemination Data collection, storage and evaluation meet all applicable data protection regulations. The trial has been approved by the Ethics Committees of the University of Wuppertal and the Medical Association of Saarland, Germany. Results will be disseminated through workshops, peer-reviewed publications and local and international conferences.Trial registration number DRKS00025485. |
| format | Article |
| id | doaj-art-caa597ca595e4e8783e58261a4eed604 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-caa597ca595e4e8783e58261a4eed6042025-08-20T02:11:40ZengBMJ Publishing GroupBMJ Open2044-60552025-04-0115410.1136/bmjopen-2024-084696Implementation of an electronic medication management support system in hospitalised polypharmacy patients: study protocol of a stepped-wedge cluster-randomised controlled trial (TOP study) Peter Ihle0Katrin Christiane Reber1Juliane Köberlein-Neu2Ingo Meyer3Matthias SchillingDaniel Grandt4Till BeckmannLara DüvelSara Söling5Simone GrandtWolfgang Greiner6Sarah Meyer7David Lampe8Adriana Poppe9Raphaele Bartels10Christoph Klaas11Adda Dumröse12Susanne DolfenNathalie SinnenCarolin PolteOlga ReschNicole FaulenbachHannah BritzBeate HalexSofie MayChristof ShelianPMV Research Group, Medical Faculty and University Hospital Cologne, University of Cologne, Köln, North Rhine-Westphalia, GermanyHealthcare Management/Strategic Analyses, AOK Nordost – Die Gesundheitskasse, Berlin, GermanyCenter for Health Economics and Health Services Research, University of Wuppertal, Wuppertal, North Rhine-Westphalia, GermanyPMV Research Group, Medical Faculty and University Hospital Cologne, University of Cologne, Köln, North Rhine-Westphalia, GermanyDepartment of Internal Medicine, Klinikum Saarbrucken gGmbH, Saarbrücken, Saarland, GermanyCenter for Health Economics and Health Services Research, University of Wuppertal, Wuppertal, North Rhine-Westphalia, GermanyDepartment of Health Economics and Health Care Management. School of Public Health, Bielefeld University, Bielefeld, North Rhine-Westphalia, GermanyCenter for Health Economics and Health Services Research, University of Wuppertal, Wuppertal, North Rhine-Westphalia, GermanyDepartment of Health Economics and Health Care Management. School of Public Health, Bielefeld University, Bielefeld, North Rhine-Westphalia, GermanyPMV Research Group, Medical Faculty and University Hospital Cologne, University of Cologne, Köln, North Rhine-Westphalia, GermanyChair of Management in Healthcare, Schumpeter School of Business and Economics, University of Wuppertal, Wuppertal, North Rhine-Westphalia, GermanyDepartment of Pharmacy, University Hospital Münster, Münster, North Rhine-Westphalia, GermanyDepartment of Digital Care/Prevention, BARMER, Wuppertal, North Rhine-Westphallia, GermanyIntroduction Polypharmacy is associated with an increased risk of adverse patient outcomes across various settings, including inpatient care. To enhance the appropriateness of medication therapy management for patients during hospital stays, computerised interventions have shown promise with regard to patient safety. This study assesses whether the implementation of a clinical decision support system will optimise the process of inpatient medication therapy to prevent inappropriate medication use and thus promote patient safety.Methods and analysis The intervention will be evaluated in a prospective, cluster-randomised controlled trial using a stepped-wedge design. The study will be conducted in 12 hospitals across Germany over a total period of 33 months. Patients will be treated according to the group status of the hospital and receive either standard care or the Transsektorale Optimierung der Patientensicherheit or trans-sectoral optimisation of patient safety intervention. The primary outcome is the combined endpoint of all-cause mortality and all-cause hospitalisation. Secondary endpoints are, for example, inappropriate prescriptions, utilisation of different health services, cost-effectiveness, as well as patient-reported outcome measures. Parameters describing the attitudes of patients and healthcare professionals towards the intervention and organisational change processes will be collected as part of the process evaluation. The primary endpoint will be evaluated using hospital and outpatient claims data from participating statutory health insurances at the population level. There are multiple secondary endpoints with data linkage of primary and secondary data at study participant level. Statistical analysis will make use of (generalised) linear mixed models or generalised estimating equations, taking account of independent covariables. All data analyses of the process evaluation will be descriptive and explorative.Ethics and dissemination Data collection, storage and evaluation meet all applicable data protection regulations. The trial has been approved by the Ethics Committees of the University of Wuppertal and the Medical Association of Saarland, Germany. Results will be disseminated through workshops, peer-reviewed publications and local and international conferences.Trial registration number DRKS00025485.https://bmjopen.bmj.com/content/15/4/e084696.full |
| spellingShingle | Peter Ihle Katrin Christiane Reber Juliane Köberlein-Neu Ingo Meyer Matthias Schilling Daniel Grandt Till Beckmann Lara Düvel Sara Söling Simone Grandt Wolfgang Greiner Sarah Meyer David Lampe Adriana Poppe Raphaele Bartels Christoph Klaas Adda Dumröse Susanne Dolfen Nathalie Sinnen Carolin Polte Olga Resch Nicole Faulenbach Hannah Britz Beate Halex Sofie May Christof Shelian Implementation of an electronic medication management support system in hospitalised polypharmacy patients: study protocol of a stepped-wedge cluster-randomised controlled trial (TOP study) BMJ Open |
| title | Implementation of an electronic medication management support system in hospitalised polypharmacy patients: study protocol of a stepped-wedge cluster-randomised controlled trial (TOP study) |
| title_full | Implementation of an electronic medication management support system in hospitalised polypharmacy patients: study protocol of a stepped-wedge cluster-randomised controlled trial (TOP study) |
| title_fullStr | Implementation of an electronic medication management support system in hospitalised polypharmacy patients: study protocol of a stepped-wedge cluster-randomised controlled trial (TOP study) |
| title_full_unstemmed | Implementation of an electronic medication management support system in hospitalised polypharmacy patients: study protocol of a stepped-wedge cluster-randomised controlled trial (TOP study) |
| title_short | Implementation of an electronic medication management support system in hospitalised polypharmacy patients: study protocol of a stepped-wedge cluster-randomised controlled trial (TOP study) |
| title_sort | implementation of an electronic medication management support system in hospitalised polypharmacy patients study protocol of a stepped wedge cluster randomised controlled trial top study |
| url | https://bmjopen.bmj.com/content/15/4/e084696.full |
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