Prevention of Adverse Drug Reactions in Hospitalized Older Patients with Multi-morbidity and Polypharmacy: the SENATOR randomized controlled clinical trial

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 Cullinane, Evelyn Flanagan, Frances Shiely, Ólafur Samuelsson, Ástrós Sverrisdóttir, Selvarani Subbarayan, Lore VandaeleEline Meireson, Beatriz Montero-Errasquín, Aurora Rexach-Cano, Andrea Correa-Pérez, 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, Joseph Eustace

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Abstract

Background: 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.
Methods: We undertook a pragmatic, multinational, parallel arm prospective randomized open-label, blinded endpoint (PROBE) controlled trial enrolling patients at 6 European medical centers. We randomized 1537 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.
Results: For the primary endpoint, there was no difference between the intervention and control groups [24.5% versus 24.8%; OR 0.98 (95% CI 0.77 to 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 (approximately 15%).
Conclusions: In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.
Original languageEnglish
JournalAge and Ageing
Early online date2 Jun 2020
DOIs
Publication statusE-pub ahead of print - 2 Jun 2020

Keywords

  • adverse drug reactions
  • older people
  • multi-morbidity
  • polypharmacy
  • prevention
  • STOPP/START criteria
  • Software

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    O’Mahony, D., Gudmundsson, A., Soiza, R. L., Petrovic, M., Jose Cruz-Jentoft, A., Cherubini, A., Fordham, R., Byrne, S., Dahly, D., Gallagher, P., Lavan, A., Curtin, D., Dalton, K., Cullinane, S., Flanagan, E., Shiely, F., Samuelsson, Ó., Sverrisdóttir, Á., Subbarayan, S., ... Eustace, J. (2020). Prevention of Adverse Drug Reactions in Hospitalized Older Patients with Multi-morbidity and Polypharmacy: the SENATOR randomized controlled clinical trial. Age and Ageing. https://doi.org/10.1093/ageing/afaa072