Polypharmacy Clinical Trial
Official title:
Effectiveness of an Intervention for Improving Drug Prescription in Primary Care Patients With Multimorbidity and Polypharmacy: Study Protocol of a Cluster Randomized Clinical Trial (Multi-PAP Project)
This study assesses the effectiveness of a complex intervention in young-old patients with multimorbidity and polypharmacy aimed at improving physician drug prescription in primary care, measured by means of the Medication Appropriateness Index (MAI)-score at six 6 (T1) and 12 (T2) months from baseline compared to usual care.
Design: Pragmatic cluster randomized clinical trial with 12 months follow-up.
Unit of randomization: general practitioner.
Unit of analysis: patient.
Setting: Primary Health Care Centres in three different Spanish Autonomous Communities
(Aragón, Madrid and Andalucía).
Population: Patients 65-74 years of age with multimorbidity (3 or more chronic diseases) and
polypharmacy (5 or more drugs taken for at least three months). N=400 patients (200 in each
arm, 5 patients per physician) will be recruited by general practitioners before
randomization.
Intervention: complex intervention.
Control group: usual care.
Variables: MAI, health care utilization, quality of life (Euroqol 5 Dimensions (5D-5L), drug
therapy and adherence (Morisky-Green, Haynes-Sackett), clinical and socio-demographic
factors. Economic appraisal variables: time spent training FPs, cost of teaching staff, time
spent on physician-patient interviews, utilities measured using the EuroQol 5D-5L.
Analysis: All analyses will be carried out adhering to the intention-to-treat principle.
Description of baseline characteristics. Basal comparison between groups. Analysis of main
and secondary effectiveness (between-group difference in T1-T0 MAI score, with corresponding
95% Confidence Interval); multilevel analysis will be used to adjust models. Estimated
quality-adjusted life years (QALYs) gained at the population level. Calculation of
cost-utility ratio.
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