• Denis O'Mahony, Adalsteinn Gudmundsson, Roy L Soiza, Mirko Petrovic, Alfonso Jose Cruz-Jentoft, Antonio Cherubini, Richard Fordham, Stephen Byrne, Darren Dahly, Paul Gallagher, Amanda Lavan, Denis Curtin, Kieran Dalton, Shane Cullinan, Evelyn Flanagan, Frances Shiely, Olafur Samuelsson, Astros Sverrisdottir, Selvarani Subbarayan, Lore Vandaele, Eline Meireson, Beatriz Montero-Errasquin, Aurora Rexach-Cano, Andrea Correa Perez, Isabel Lozano-Montoya, Manuel Vélez-Díaz-Pallarés, Annarita Cerenzia, Samanta Corradi, Maria Soledad Cotorruelo Ferreiro, Federica Dimitri, Paolo Marinelli, Gaia Martelli, Rebekah Fong Soe Khioe, and Joseph Eustace.
• University College Cork School of Medicine-Medicine Cork Ireland, Cork University Hospital Group, Cork, Ireland.
• Age Ageing. 2020 Jul 1; 49 (4): 605-614.

BackgroundMulti-morbidity and polypharmacy increase the risk of non-trivial adverse drug reactions (ADRs) in older people during hospitalization. Despite this, there are no established interventions for hospital-acquired ADR prevention.MethodsWe undertook a pragmatic, multi-national, parallel arm prospective randomized open-label, blinded endpoint (PROBE) controlled trial enrolling patients at six European medical centres. We randomized 1,537 older medical and surgical patients with multi-morbidity and polypharmacy on admission in a 1:1 ratio to SENATOR software-guided medication optimization plus standard care (intervention, n = 772, mean number of daily medications = 9.34) or standard care alone (control, n = 765, mean number of daily medications = 9.23) using block randomization stratified by site and admission type. Attending clinicians in the intervention arm received SENATOR-generated advice at a single time point with recommendations they could choose to adopt or not. The primary endpoint was occurrence of probable or certain ADRs within 14 days of randomization. Secondary endpoints were primary endpoint derivatives; tertiary endpoints included all-cause mortality, re-hospitalization, composite healthcare utilization and health-related quality of life.ResultsFor the primary endpoint, there was no difference between the intervention and control groups (24.5 vs. 24.8%; OR 0.98; 95% CI 0.77-1.24; P = 0.88). Similarly, with secondary and tertiary endpoints, there were no significant differences. Among attending clinicians in the intervention group, implementation of SENATOR software-generated medication advice points was poor (~15%).ConclusionsIn this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.© The Author(s) 2020. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

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