TY - JOUR
T1 - Prevention of Adverse Drug Reactions in Hospitalized Older Patients with Multi-morbidity and Polypharmacy
T2 - the SENATOR randomized controlled clinical trial
AU - O’Mahony, Denis
AU - Gudmundsson, Adalsteinn
AU - Soiza, Roy L.
AU - Petrovic, Mirko
AU - Jose Cruz-Jentoft, Alfonso
AU - Cherubini, Antonio
AU - Fordham, Richard
AU - Byrne, Stephen
AU - Dahly, Darren
AU - Gallagher, Paul
AU - Lavan, Amanda
AU - Curtin, Denis
AU - Dalton, Kieran
AU - Cullinane, Shane
AU - Flanagan, Evelyn
AU - Shiely, Frances
AU - Samuelsson, Ólafur
AU - Sverrisdóttir, Ástrós
AU - Subbarayan, Selvarani
AU - Vandaele, Lore
AU - Meireson, Eline
AU - Montero-Errasquín, Beatriz
AU - Rexach-Cano, Aurora
AU - Correa-Pérez, Andrea
AU - Lozano-Montoya, Isabel
AU - Vélez-Díaz-Pallarés, Manuel
AU - Cerenzia, Annarita
AU - Corradi, Samanta
AU - Soledad Cotorruelo Ferreiro, Maria
AU - Dimitri, Federica
AU - Marinelli, Paolo
AU - Martelli, Gaia
AU - Fong Soe Khioe, Rebekah
AU - Eustace, Joseph
N1 - Acknowledgements: The trial was co-ordinated and the trial database was managed by the staff of the Health Research Board Clinical Research Facilities at University College Cork (HRB CRF-C). The authors wish to thank the patients and staff of the participating hospitals for their cooperation: (i) Cork University Hospital, Cork, Ireland. (ii) Ghent University Hospital, Ghent, Belgium. (iii)
Hospital Universitario Ramón y Cajal, Madrid, Spain. (iv) Ospedali Riuniti, Ancona, Italy. (v) Landspitali University Hospital, Reykjavik, Iceland. (vi) Aberdeen Royal Infirmary, Aberdeen, Scotland. The authors wish to acknowledge the
contributions of the staff of the following organizations in the SENATOR trial: (i) ClinInfo S.A, Lyons, France (Philippe Foerster). (ii) ARTTIC International Management Services, Munich, Germany (Dr Otilia Postea). (iii) Clanwilliam Health, Dublin, Ireland (Joseph McMullin, Anthony Maguire). (iv) HRB Clinical Research Facility— Cork, Cork, Ireland (Mary-Claire O’Regan, Aoife Harvey,
Ruben Keane, Máire McCarthy, Sarah O’Meara). The authors further wish to acknowledge the oversight of the external Scientific Advisory Board (SAB) and the Ethics and Safety Review Group (ESRG) during the conduct of the SENATOR trial. SAB members included: Prof. Cillian Twomey (chairperson), Prof. Peter Crome, Dr Paul Jansen, Prof. Anne Spinewine, Prof. Jamie Coleman, Prof. Tischa van der Cammen and Prof. Jose M. Ribera-Casado. ESRG members included Prof. Shaun O’Keeffe (chairperson), Prof. Liam Plant and Robin Webster (older person advocate).
Funding: This work was supported by the European Commission’s Seventh Framework Programme (FP7/2007– 2013) (grant number 305930) as part of the SENATOR project.
PY - 2020/7
Y1 - 2020/7
N2 - 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 (similar to 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.
AB - 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 (similar to 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.
KW - adverse drug reactions
KW - older people
KW - multi-morbidity
KW - polypharmacy
KW - prevention
KW - STOPP/START criteria
KW - Software
KW - software
KW - RISK-FACTORS
KW - EVENTS
KW - ADULTS
KW - INPATIENTS
KW - RIGHT TREATMENT CRITERIA
KW - INTERVENTIONS
KW - PHARMACIST
KW - SCREENING TOOL
KW - QUALITY-OF-LIFE
KW - ELDERLY-PATIENTS
KW - Adverse drug reactions
KW - Prevention
KW - Polypharmacy
KW - Older people
KW - Multi-morbidity
UR - http://www.scopus.com/inward/record.url?scp=85087530568&partnerID=8YFLogxK
U2 - 10.1093/ageing/afaa072
DO - 10.1093/ageing/afaa072
M3 - Article
VL - 49
SP - 605
EP - 614
JO - Age and Ageing
JF - Age and Ageing
SN - 0002-0729
IS - 4
ER -