223 OPERAM: cluster randomised controlled trial reduction in hospital admissions [16,26], other RCTs failed to demonstrate any relevant benefit on clinical outcomes [7,27]. However, the certainty of the evidence was deemed to be very low because of limitations in the study design, including risk of bias (e.g. contamination bias due to non-cluster randomization, outcome assessment bias due to non-adjudicated outcomes), lack of statistical power (small sample size), short follow-up, or being single-site studies [7]. Adequately powered high-quality trials are therefore needed to assess the potential clinical benefit of pharmacotherapy optimization; if effective, optimization of pharmacotherapy could lead to major improvements in the care of the growing population of older multimorbid individuals with polypharmacy. Improving medication appropriateness is particularly important among inpatients, given that hospitalization is a risk factor for drug-related adverse events and inappropriate prescribing [16]. Aiming to overcome the limitations of previous pharmacotherapy optimization studies [7], we conducted a large-scale multicentre cluster-RCT assessing the effect of a multidisciplinary optimization of pharmacotherapy, supported by a softwarebased clinical decision-support tool on adjudicated drug-related hospital admissions and other clinical outcomes in older multimorbid patients with polypharmacy, compared to usual care. Methods Trial design The rationale and design of the OPERAM trial have been published previously [28]. We conducted a multi-centre, partially-blinded cluster-RCT among older multimorbid patients with polypharmacy, who were admitted to hospital. The trial assessed the effects of a structured pharmacotherapy optimization intervention on drug-related hospital admission and was conducted in four university-based hospitals located in four European countries (Bern, Switzerland; Utrecht, The Netherlands; Louvain, Belgium; Cork, Ireland). Written informed consent was obtained from patients or legal representatives before enrolment. Patients Patients aged ≥70 years with multimorbidity (≥3 chronic medical conditions defined by ICD-10 codes with an estimated duration of ≥6 months or based on a clinical decision) and polypharmacy (≥5 daily long-term drugs for >30 days prior to eligibility assessment) who were admitted to a participating hospital ward were eligible for inclusion if their expected minimal length of stay within the cluster was sufficient to apply the intervention. Both medical and surgical admissions, as well as both 3
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