TY - JOUR
T1 - Rationale and design of OPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people (OPERAM)
T2 - a cluster randomised controlled trial
AU - Adam, Luise
AU - Moutzouri, Elisavet
AU - Baumgartner, Christine
AU - Loewe, Axel Lennart
AU - Feller, Martin
AU - M'Rabet-Bensalah, Khadija
AU - Schwab, Nathalie
AU - Hossmann, Stefanie
AU - Schneider, Claudio
AU - Jegerlehner, Sabrina
AU - Floriani, Carmen
AU - Limacher, Andreas
AU - Jungo, Katharina Tabea
AU - Huibers, Corlina Johanna Alida
AU - Streit, Sven
AU - Schwenkglenks, Matthias
AU - Spruit, Marco
AU - Van Dorland, Anette
AU - Donzé, Jacques
AU - Kearney, Patricia M
AU - Jüni, Peter
AU - Aujesky, Drahomir
AU - Jansen, Paul
AU - Boland, Benoit
AU - Dalleur, Olivia
AU - Byrne, Stephen
AU - Knol, Wilma
AU - Spinewine, Anne
AU - O'Mahony, Denis
AU - Trelle, Sven
AU - Rodondi, Nicolas
N1 - Funding Information:
This work is supported by the European Union's Horizon 2020 research and innovation program under the grant agreement No. 6342388, and by the Swiss State Secretariat for Education, Research and Innovation (SERI) under contract number 15.0137.
Publisher Copyright:
© 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.
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2019/6/1
Y1 - 2019/6/1
N2 - 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.
AB - 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.
KW - clinical pharmacology
KW - general medicine (see internal medicine)
KW - geriatric medicine
KW - internal medicine
UR - https://www.scopus.com/pages/publications/85066947365
U2 - 10.1136/bmjopen-2018-026769
DO - 10.1136/bmjopen-2018-026769
M3 - Article
C2 - 31164366
SN - 2044-6055
VL - 9
JO - BMJ Open
JF - BMJ Open
IS - 6
M1 - e026769
ER -