228 CHAPTER 3.2 This study was registered with ClinicalTrials.gov, NCT02986425. The trial results are reported in line with the CONSORT extension for Cluster Trials [54]. Patient and public involvement As part of the OPERAM project, patients and family caregivers, healthcare professionals and experts were involved in interviews and an international Delphi survey to develop an international core outcome set for clinical trials of medication review in multimorbid older patients with polypharmacy [41]; this core outcome set was added to the OPERAM trial outcomes. The contribution of patients and family caregivers was pivotal to the choice of the core outcome set, particularly for the final inclusion of ‘pain relief’ as one of the seven outcomes retained in this set [41]. Results Between December 1, 2016 and October 31, 2018, 2,008 patients (median age 79 years [interquartile range, IQR, 74 to 84 years]; 898 [44.7%] female) provided consent and were enrolled in 54 intervention clusters (963 patients) and 56 control clusters (1,045 patients) (Figure 1, Figure SI1.1). During follow-up, ten (0.5%) patients were lost to follow-up, 118 (5.9%) withdrew from the trial, and 385 (19.2%) died. Cluster size, specialty type and time interval between first and final patient recruitment were similar between groups (Table 1). Patient characteristics, number of comorbidities, number of daily medications and length of stay during index hospitalization were also similar between groups. The patients had a median number of 9 medications and 11 comorbidities at baseline. Medications were similar between groups (Table SI1.1). The average per-patient time spent on the full intervention, including data recording and discussion with the patient, was 97 minutes. Of 916 patients who received the intervention (Figure 1), 789 (86.1%) had ≥1 STOPP/ START recommendation provided to their attending hospital physician, with a mean (SD) of 2.75 (2.24) recommendations per patient (Table 2). Implicit STOPP criteria, such as STOPP A1 and A3 criteria, were common (Table 3). After 2 months, ≥1 of these recommendations were successfully implemented in 491 patients (62.2% of all patients in the intervention group with ≥1 recommendation), with a mean of 1.16 implemented recommendations per patient, primarily discontinuation of potentially inappropriate medications (Table 3).
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