Denis O'Mahony1, Adalsteinn Gudmundsson2, Roy L Soiza3, Mirko Petrovic4, Alfonso Jose Cruz-Jentoft5, Antonio Cherubini6, Richard Fordham7, Stephen Byrne8, Darren Dahly9, Paul Gallagher10, Amanda Lavan11, Denis Curtin11, Kieran Dalton12, Shane Cullinan13, Evelyn Flanagan14, Frances Shiely15, Olafur Samuelsson16, Astros Sverrisdottir16, Selvarani Subbarayan17, Lore Vandaele18, Eline Meireson18, Beatriz Montero-Errasquin5, Aurora Rexach-Cano5, Andrea Correa Perez5, Isabel Lozano-Montoya5, Manuel Vélez-Díaz-Pallarés5, Annarita Cerenzia6, Samanta Corradi6, Maria Soledad Cotorruelo Ferreiro6, Federica Dimitri6, Paolo Marinelli6, Gaia Martelli6, Rebekah Fong Soe Khioe19, Joseph Eustace20. 1. University College Cork School of Medicine-Medicine Cork Ireland, Cork University Hospital Group, Cork, Ireland. 2. Landspitali University Hospital Reykjavik, Landspitali, Iceland. 3. NHS Grampian, University of Aberdeen Institute of Applied Health Sciences-Ageing Clinical and Experimental Research, Aberdeen, UK. 4. University of Ghent-Medicine, University Hospital Ghent, Ghent, Belgium. 5. Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain. 6. Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy. 7. Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK. 8. School of Pharmacy, University College Cork, Cork, Ireland. 9. University College Cork, Cork, Ireland. 10. Cork University Hospital-Geriatric Medicine, Cork, Ireland. 11. University College Cork, School of Medicine-Geriatrics, Cork, Ireland. 12. University College Cork, National University of Ireland, Pharmaceutical Care Research Group, School of Pharmacy, Cork Ireland. 13. Royal College of Surgeons, School of Pharmacy, Dublin, Ireland. 14. University College Cork, Clinical Research Facility, Cork, Ireland. 15. University College Cork, School of Epidemiology and Public Health, Cork, Ireland. 16. Landspitali University Hospital, Geriatric Medicine Reykjavik, Iceland. 17. NHS Grampian, Aberdeen Royal Infirmary, Aberdeen UK. 18. University Hospital Ghent, Ghent, Belgium. 19. University of East Anglia, Faculty of Medicine and Health Sciences, Norwich, UK. 20. University College Cork, National University of Ireland-Clinical Research Facility, Cork, Ireland.
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, 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. RESULTS: For 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%). CONCLUSIONS: In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.
RCT Entities:
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, 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. RESULTS: For 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%). CONCLUSIONS: In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.
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