Open Randomised Multicentric Controlled Trial to Evaluate the Impact of an Intervention to Improve Drug Appropriateness in Polymedicated Patients According to the Person-centered Care Model by a Multidisciplinary Team At Primary Care

Detailed Summary

Introduction: In recent years, multi-aging has increased by 25%. This is related to plutipatology, frailty, polymedications, elevated sanitary cost, low quality of life, adverse events and mortality. To improve this it is necessary to apply the people-centered care model that includes and individualized therapeutic plan taking into account medication appropriateness, frailty, complexity and patient preferences. A collaborative model by a multidisciplinary team is proposed to make decisions to optimize drug therapy. Hypothesis: person-centered care model by a multidisciplinary team at primary care improve drug appropriateness in polymedicated elderly patients Material and Method: Design: Randomized (1:1), open-label, multicentre, parallel-arm clinical trial with 1-year follow-up. Study population: community-dwelling polymedicated (≥8 drugs) elderly (≥75 years old) people at 11 primary healthcare team in Bages, Osona and Anoia (Catalonian region). Period: May 2020 and ends at 12 months of follow-up of the last included subject. Method: 11 primary healthcare team will be randomized to control or intervention group, then volunteers basic healthcare team will participate in the study and they will be assigned to control or intervention group depending on which team they work, then the subjects assigned to theses basic healthcare teams that meet the inclusion criteria and not exclusion criteria will be selected and finally the informed consent of these will be obtained. In the intervention group the multidisciplinary work team comprised by the clinical pharmacist, expert collaborator doctor and the basic healthcare team will meet periodically to review subjects, a multidimensional review will be carried out by assessing the frailty, complexity, morbidity and the appropriateness drug therapy, if proposed changes in the therapeutic plan will have to be agreed with the patient taking into account their preferences. At 6 and 12 months or when their basic healthcare team requests it they will be reviewed again. In the control group the necessary study data collection will be carry out at the beginning and at 6 and 12 months, and the routine clinical practice in relation to the use of medication will be carried out. Measurements: variation of the mean of incidents (potencially prescription inadequate) per patient, variation of the number of prescribed drugs per patient, changes in the therapeutic plans implemented and variation of the number of hospitalizations.

Study Details

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Interventions