Prevention of adverse drug reactions in hospitalized older patients with multi-morbidity and polypharmacy: the SENATOR* randomized controlled clinical trial

• DOI: 10.1093/ageing/afaa072
• Publication Date: 2020-03-31T19:13:46Z
• Authors: Denis O'Mahony; Adalsteinn Gudmun...; Roy L Soiza; Mirko Petrovic; Alfonso Jose Cruz...; 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-E...; Aurora Rexach-Cano; Andrea Correa Perez; Isabel Lozano-Mon...; Manuel Vélez-Díaz...; Annarita Cerenzia; Samanta Corradi; Maria Soledad Cot...; Federica Dimitri; Paolo Marinelli; Gaia Martelli; Rebekah Fong Soe ...; Joseph Eustace
• Keywords: Clinical endpoint

Multi-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.We undertook a pragmatic, multi-national, parallel arm prospective randomized open-label, blinded endpoint (PROBE) controlled trial enrolling patients at six European medical centres. We 1,537 surgical with multi-morbidity on admission 1:1 ratio to SENATOR software-guided medication optimization plus standard care (intervention, n = 772, mean number daily medications 9.34) or alone (control, 765, 9.23) using block randomization stratified by site type. Attending clinicians intervention received SENATOR-generated advice single time point recommendations they could choose adopt not. The primary was occurrence probable certain ADRs within 14 days randomization. Secondary endpoints were derivatives; tertiary included all-cause mortality, re-hospitalization, composite healthcare utilization health-related quality life.For endpoint, difference between control groups (24.5 vs. 24.8%; OR 0.98; 95% CI 0.77-1.24; P 0.88). Similarly, secondary endpoints, significant differences. Among attending group, implementation software-generated points poor (~15%).In this trial, uptake minimize did not reduce incidence index