224 CHAPTER 3.2 elective and emergency admissions were included if the patient was ultimately hospitalized. To increase external validity [29], we applied few exclusion criteria: 1) planned transfer to palliative care ≤24 hours after admission, 2) patients with report of any structured medication review performed by a clinician ≤2 months prior to enrolment, 3) inability to provide written informed consent or to obtain written informed consent from a proxy. Randomization and blinding The clusters were defined at the level of attending hospital physicians. No specific eligibility criteria were defined for physicians other than sufficient enrolment potential. Physicians were sequentially enrolled over 21 months and allocated in a 1:1 ratio to the intervention or control arms. To ensure intervention safety and to enable shared decision-making with the patients, the trial was partially blinded. The intervention team consisted of a physician and a pharmacist; neither was blinded in order to have direct interactions with both the attending hospital physicians and the patients. Patients, hospital physicians, and general practitioners (GPs) were partially blinded and received only general trial information without specific details about the intervention. Each cluster-defining hospital physician signed a discretion contract to keep trial arm allocations confidential and not to share information with colleagues. In addition, cluster-defining hospital physicians worked on separate hospital units and were autonomous in their treatment decisions, further minimizing between-cluster contamination. To limit selection bias [30], the recruitment team, the teams conducting follow-up calls, and the adjudication teams consisting of pharmacists and physicians were fully blinded. Trial procedures The trial protocol describing the intervention used in OPERAM has been previously published [31]. The intervention was performed on the individual patient level and consisted of a structured medication review using STRIP, a process developed to support pharmacotherapy optimization in older patients. STRIP combines the STOPP/START criteria [22] to detect medication overuse and underuse with implicit drug appropriateness assessment methods, such as structured questions on medication history, therapy adherence, adverse drug reactions, and shared decision-making with the patient on proposed medication changes [23]. Detailed description of the intervention is available in Methods appendix. This process was supported by the web-based STRIPA (see Methods appendix), a decision-support system that takes into account clinically relevant interactions, dose adjustment according to renal function, and predictable adverse drug effects [23,32,33].
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