225 OPERAM: cluster randomised controlled trial Pre-admission medication was assessed using the Structured History taking of Medication (SHiM) questionnaire [34] (see Methods appendix), and entered into STRIPA along with the patient’s current diagnoses and relevant laboratory values. A trained research physician and pharmacist jointly performed the STRIP medication review, and generated patient-specific prescribing recommendations based on STOPP/START criteria, with possible adaptations after discussion with the attending hospital physician and the patient to take patient preferences into account. After considering additional in-hospital clinical information (e.g. new diagnoses, adverse drug reaction history), a final report was sent to the patient’s GP with further recommendations that could not be implemented during the index hospitalization. The control group received usual care that could include unstructured medication review by the attending hospital physicians, which was not specifically encouraged or discussed. Usual care was performed according to site-specific standards of care that did not include application of STOPP/START criteria or STRIP. To mimic the intervention for blinding purposes of the patients and blinded team members, a sham intervention was administered to all patients by the intervention team through completion of the Morisky Medication Adherence Measure Questionnaire (©MMAS-8) [35–37]. Follow-up and outcome data were collected by blinded team members through telephone interviews with the patients or their proxies at 2, 6 and 12 months postrandomization. When a hospital admission (at the index hospital or any other hospital) was identified, a second unblinded team gathered hospitalization data and concealed all information identifying the intervention allocation before sending it to the adjudication team. Outcomes The primary outcome was the first confirmed drug-related hospital admission after discharge following the index hospitalization within 12 months of enrolment. An independent blinded adjudication committee at each trial site, consisting of physicians and pharmacists, consecutively adjudicated all hospital admissions (both medical and surgical) for drug relatedness according to a previously published standardized adjudication guideline [38]. Briefly, potential adverse drug events were identified with the aid of triggers (linked to both causative drugs and potential causes for underuse) and screening questions, based on review of medical records and medication lists. If goals of care or patient preferences were documented in the medical record, these were also taken into account by the adjudication team. Confirmed adverse drug events were then adjudicated by the blinded adjudication committee for relatedness to the hospital admission. When adverse drug events were judged to be the main or a significant contributory reason, the admission 3
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