Optimizing Therapy to Prevent Avoidable Hospital Admissions in Multimorbid Older Adults (OPERAM): Cluster randomised controlled trial
Blum, Manuel R.; Sallevelt, Bastiaan T.G.M.; Spinewine, Anne; O'Mahony, Denis; Moutzouri, Elisavet; Feller, Martin; Baumgartner, Christine; Roumet, Marie; Jungo, Katharina Tabea; Schwab, Nathalie; Bretagne, Lisa; Beglinger, Shanthi; Aubert, Carole E.; Wilting, Ingeborg; Thevelin, Stefanie; Murphy, Kevin; Huibers, Corlina J.A.; Clara Drenth-Van Maanen, A.; Boland, Benoit; Crowley, Erin; Eichenberger, Anne; Meulendijk, Michiel; Jennings, Emma; Adam, Luise; Roos, Marvin J.; Gleeson, Laura; Shen, Zhengru; Marien, Sophie; Meinders, Arend Jan; Baretella, Oliver; Netzer, Seraina; De Montmollin, Maria; Fournier, Anne; Mouzon, Ariane; O'Mahony, Cian; Aujesky, Drahomir; Mavridis, Dimitris; Byrne, Stephen; Jansen, Paul A.F.; Schwenkglenks, Matthias; Spruit, Marco; Dalleur, Olivia; Knol, Wilma; Trelle, Sven; Rodondi, Nicolas
(2021) The BMJ, volume 374
(Article)
Abstract
Objective To examine the effect of optimising drug treatment on drug related hospital admissions in older adults with multimorbidity and polypharmacy admitted to hospital. Design Cluster randomised controlled trial. Setting 110 clusters of inpatient wards within university based hospitals in four European countries (Switzerland, Netherlands, Belgium, and Republic of Ireland)
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defined by attending hospital doctors. Participants 2008 older adults (≥70 years) with multimorbidity (≥3 chronic conditions) and polypharmacy (≥5 drugs used long term). Intervention Clinical staff clusters were randomised to usual care or a structured pharmacotherapy optimisation intervention performed at the individual level jointly by a doctor and a pharmacist, with the support of a clinical decision software system deploying the screening tool of older person's prescriptions and screening tool to alert to the right treatment (STOPP/START) criteria to identify potentially inappropriate prescribing. Main outcome measure Primary outcome was first drug related hospital admission within 12 months. Results 2008 older adults (median nine drugs) were randomised and enrolled in 54 intervention clusters (963 participants) and 56 control clusters (1045 participants) receiving usual care. In the intervention arm, 86.1% of participants (n=789) had inappropriate prescribing, with a mean of 2.75 (SD 2.24) STOPP/START recommendations for each participant. 62.2% (n=491) had ≥1 recommendation successfully implemented at two months, predominantly discontinuation of potentially inappropriate drugs. In the intervention group, 211 participants (21.9%) experienced a first drug related hospital admission compared with 234 (22.4%) in the control group. In the intention-to-treat analysis censored for death as competing event (n=375, 18.7%), the hazard ratio for first drug related hospital admission was 0.95 (95% confidence interval 0.77 to 1.17). In the per protocol analysis, the hazard ratio for a drug related hospital admission was 0.91 (0.69 to 1.19). The hazard ratio for first fall was 0.96 (0.79 to 1.15; 237 v 263 first falls) and for death was 0.90 (0.71 to 1.13; 172 v 203 deaths). Conclusions Inappropriate prescribing was common in older adults with multimorbidity and polypharmacy admitted to hospital and was reduced through an intervention to optimise pharmacotherapy, but without effect on drug related hospital admissions. Additional efforts are needed to identify pharmacotherapy optimisation interventions that reduce inappropriate prescribing and improve patient outcomes. Trial registration ClinicalTrials.gov NCT02986425.
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Keywords: General Medicine, Journal Article, Research Support, Non-U.S. Gov't
ISSN: 1756-1833
Publisher: BMJ Publishing Group
Note: Funding Information: Contributors: MR and ST had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. NR, ST, DOM, AS, WK, and MS conceived and designed the study. All authors contributed to data acquisition, analysis, and interpretation. MR and ST performed the statistical analyses. MRB and NR drafted the manuscript. All authors revised the manuscript for important intellectual content. NR, DOM, AS, WK, MS, and MS obtained funding. NR, DOM, AS, WK, NS, and MS were responsible for administrative, technical, and material support. NR, ST, DOM, AS, and WK supervised the study. NR is the guarantor. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. Funding: This work is part of the project OPERAM: OPtimising thERapy to prevent Avoidable hospital admissions in the Multimorbid elderly supported by the European Union’s Horizon 2020 research and innovation programme under grant agreement No 634238, and by the Swiss State Secretariat for Education, Research, and Innovation Funding Information: (SERI) under contract number 15.0137. The opinions expressed herein are those of the authors and do not necessarily reflect the official views of the European Commission and the Swiss government. This project was also partially funded by the Swiss National Scientific Foundation (SNSF 320030_188549). The funder of the study had no role in the study design; data collection, analysis, and interpretation; or writing of the report. MR and ST had full access to all the data in the study, and all authors had final responsibility for the decision to submit for publication. Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: financial support from grants from Swiss State Secretariat for Education, Research, and Innovation (NR, MSch), EU Horizon 2020 (LG), Gottfried and Julia Bangerter Rhyner Stiftung (LA), European Commission (ST, MR), during the conduct of the study. ST and MR are affiliated with CTU Bern, University of Bern, which has a staff policy of not accepting honorariums or consultancy fees. However, CTU Bern is involved in design, conduct, or analysis of clinical studies funded by not-for-profit and for profit organisations. In particular, pharmaceutical and medical device companies provide direct funding to some of these studies or an up-to-date list of CTU Bern’s conflicts of interest see https://www.ctu.unibe.ch/research/declaration_of_interest/ index_eng.html. DOM has a patent A Prescription Decision Support System (based on screening tool of older person’s prescriptions and screening tool to alert to the right treatment (STOPP/START) prescribing rules) issued to European Patent Office (Munich). MS reports a 2011 grant and personal fees from Spru IT, before the conduct of the study; in addition, MS reports a settlement agreement between Spru IT and Utrecht University, in which all systematic tool to reduce inappropriate prescribing (STRIP) assistant IP is transferred to Utrecht University, in exchange for obtaining a free but non-exclusive right to provide STRIP assistant consultancy or support services, or both on a commercial basis, and to update the STRIP assistant, until June 2023. Publisher Copyright: ©
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