Rationale and design of OPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people (OPERAM): a cluster randomised controlled trial

Luise Adam, Elisavet Moutzouri, Christine Baumgartner, Axel Lennart Loewe, Martin Feller, Khadija M'Rabet-Bensalah, Nathalie Schwab, Stefanie Hossmann, Claudio Schneider, Sabrina Jegerlehner, Carmen Floriani, Andreas Limacher, Katharina Tabea Jungo, Corlina Johanna Alida Huibers, Sven Streit, Matthias Schwenkglenks, Marco Spruit, Anette Van Dorland, Jacques Donzé, Patricia M Kearney, Peter Jüni, Drahomir Aujesky, Paul Jansen, Benoit Boland, Olivia Dalleur, Stephen Byrne, Wilma Knol, Anne Spinewine, Denis O'Mahony, Sven Trelle, Nicolas Rodondi, Luise Adam, Elisavet Moutzouri, Christine Baumgartner, Axel Lennart Loewe, Martin Feller, Khadija M'Rabet-Bensalah, Nathalie Schwab, Stefanie Hossmann, Claudio Schneider, Sabrina Jegerlehner, Carmen Floriani, Andreas Limacher, Katharina Tabea Jungo, Corlina Johanna Alida Huibers, Sven Streit, Matthias Schwenkglenks, Marco Spruit, Anette Van Dorland, Jacques Donzé, Patricia M Kearney, Peter Jüni, Drahomir Aujesky, Paul Jansen, Benoit Boland, Olivia Dalleur, Stephen Byrne, Wilma Knol, Anne Spinewine, Denis O'Mahony, Sven Trelle, Nicolas Rodondi

Abstract

Introduction: Multimorbidity and polypharmacy are important risk factors for drug-related hospital admissions (DRAs). DRAs are often linked to prescribing problems (overprescribing and underprescribing), as well as non-adherence with drug regimens for different reasons. In this trial, we aim to assess whether a structured medication review compared with standard care can reduce DRAs in multimorbid older patients with polypharmacy.

Methods and analysis: OPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people is a European multicentre, cluster randomised, controlled trial. Hospitalised patients ≥70 years with ≥3 chronic medical conditions and concurrent use of ≥5 chronic medications are included in the four participating study centres of Bern (Switzerland), Utrecht (The Netherlands), Brussels (Belgium) and Cork (Ireland). Patients treated by the same prescribing physician constitute a cluster, and clusters are randomised 1:1 to either standard care or Systematic Tool to Reduce Inappropriate Prescribing (STRIP) intervention with the help of a clinical decision support system, the STRIP Assistant. STRIP is a structured method performing customised medication reviews, based on Screening Tool of Older People's Prescriptions/Screening Tool to Alert to Right Treatment criteria to detect potentially inappropriate prescribing. The primary endpoint is any DRA where the main reason or a contributory reason for the patient's admission is caused by overtreatment or undertreatment, and/or inappropriate treatment. Secondary endpoints include number of any hospitalisations, all-cause mortality, number of falls, quality of life, degree of polypharmacy, activities of daily living, patient's drug compliance, the number of significant drug-drug interactions, drug overuse and underuse and potentially inappropriate medication.

Ethics and dissemination: The local Ethics Committees in Switzerland, Ireland, The Netherlands and Belgium approved this trial protocol. We will publish the results of this trial in a peer-reviewed journal.

Main funding: European Union's Horizon 2020 programme.

Trial registration number: NCT02986425 , SNCTP000002183 , NTR6012, U1111-1181-9400.

Keywords: clinical pharmacology; general medicine (see internal medicine); geriatric medicine; internal medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study flowchart (*planned numbers).

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