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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=500 patients (250 in each arm, 7 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 5D-5L), drug therapy and adherence (Morisky-Green, Haynes-Sackett), clinical and socio-demographic factors.
Analysis: Primary outcome: difference in MAI Score 6 months from baseline with its corresponding 95% CI. Adjustment by main confounding and prognostic factors will be performed though a multilevel analysis. All analyses will be carried out adhering to the intention-to-treat principle.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
Multi-PAP, Usual care
Not yet recruiting
Instituto Aragones de Ciencias de la Salud
Published on BioPortfolio: 2016-08-16T10:08:21-0400
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