• Alexandra Prados-Torres, Del Cura-GonzálezIsabelIRed de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC) ISCIII, Madrid, Spain.Unidad de Apoyo a la Investigación, Gerencia Asistencial de Atención Primaria, Servicio Madrileño de Salud, Madrid, Spain.Área Med, Daniel Prados-Torres, Juan A López-Rodríguez, Francisca Leiva-Fernández, Amaia Calderón-Larrañaga, Fernando López-Verde, Luis A Gimeno-Feliu, Esperanza Escortell-Mayor, Victoria Pico-Soler, Teresa Sanz-Cuesta, Mª Josefa Bujalance-Zafra, Mariel Morey-Montalvo, José Ramón Boxó-Cifuentes, Beatriz Poblador-Plou, José Manuel Fernández-Arquero, Francisca González-Rubio, María D Ramiro-González, Carlos Coscollar-Santaliestra, Jesús Martín-Fernández, Mª Pilar Barnestein-Fonseca, José María Valderas-Martínez, Alessandra Marengoni, Christiane Muth, and Multi-PAP Group.
• Instituto Aragonés de Ciencias de la Salud (IACS), IIS Aragón, Hospital Universitario Miguel Servet, Paseo Isabel La Católica 1-3, 50009, Zaragoza, Spain. sprados.iacs@aragon.es.
• Implement Sci. 2017 Apr 27; 12 (1): 54.

BackgroundMultimorbidity is associated with negative effects both on people's health and on healthcare systems. A key problem linked to multimorbidity is polypharmacy, which in turn is associated with increased risk of partly preventable adverse effects, including mortality. The Ariadne principles describe a model of care based on a thorough assessment of diseases, treatments (and potential interactions), clinical status, context and preferences of patients with multimorbidity, with the aim of prioritizing and sharing realistic treatment goals that guide an individualized management. The aim of this study is to evaluate the effectiveness of a complex intervention that implements the Ariadne principles in a population of young-old patients with multimorbidity and polypharmacy. The intervention seeks to improve the appropriateness of prescribing in primary care (PC), as measured by the medication appropriateness index (MAI) score at 6 and 12 months, as compared with usual care.Methods/DesignDesign: pragmatic cluster randomized clinical trial. Unit of randomization: family physician (FP). Unit of analysis: patient.ScopePC health centres in three autonomous communities: Aragon, Madrid, and Andalusia (Spain).Populationpatients aged 65-74 years with multimorbidity (≥3 chronic diseases) and polypharmacy (≥5 drugs prescribed in ≥3 months).Sample Sizen = 400 (200 per study arm).Interventioncomplex intervention based on the implementation of the Ariadne principles with two components: (1) FP training and (2) FP-patient interview.OutcomesMAI score, health services use, quality of life (Euroqol 5D-5L), pharmacotherapy and adherence to treatment (Morisky-Green, Haynes-Sackett), and clinical and socio-demographic variables.Statistical Analysisprimary outcome is the difference in MAI score between T0 and T1 and corresponding 95% confidence interval. Adjustment for confounding factors will be performed by multilevel analysis. All analyses will be carried out in accordance with the intention-to-treat principle.DiscussionIt is essential to provide evidence concerning interventions on PC patients with polypharmacy and multimorbidity, conducted in the context of routine clinical practice, and involving young-old patients with significant potential for preventing negative health outcomes.Trial RegistrationClinicaltrials.gov, NCT02866799.

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