TY  - JOUR
A1  - Prados-Torres, Alexandra
A1  - Cura-González, Isabel del
A1  - Prados-Torres, Daniel
A1  - López-Rodríguez, Juan Antonio
A1  - Leiva-Fernández, Francisca
A1  - Calderón-Larrañaga, Amaia
A1  - López-Verde, Fernando
A1  - Gimeno-Feliu, Luis Andres
A1  - Escortell-Mayor, Esperanza
A1  - Pico-Soler, Victoria
A1  - Sanz-Cuesta, Teresa
A1  - Bujalance-Zafra, Mª Josefa
A1  - Morey-Montalvo, Mariel
A1  - Boxó-Cifuentes, José Ramón
A1  - Poblador-Plou, Beatriz
A1  - Fernández-Arquero, José Manuel
A1  - González-Rubio, Francisca
A1  - Ramiro-González, María D.
A1  - Coscollar-Santaliestra, Carlos
A1  - Martín-Fernández, Jesús
A1  - Barnestein-Fonseca, Mª Pilar
A1  - Valderas-Martínez, José María
A1  - Marengoni, Alessandra
A1  - Muth, Christiane
T1  - 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)
T2  - Implementation science
N2  - Background: Multimorbidity 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/Design: Design: pragmatic cluster randomized clinical trial. Unit of randomization: family physician (FP). Unit of analysis: patient. Scope: PC health centres in three autonomous communities: Aragon, Madrid, and Andalusia (Spain). Population: patients aged 65–74 years with multimorbidity (≥3 chronic diseases) and polypharmacy (≥5 drugs prescribed in ≥3 months). Sample size: n = 400 (200 per study arm). Intervention: complex intervention based on the implementation of the Ariadne principles with two components: (1) FP training and (2) FP-patient interview. Outcomes: MAI 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 analysis: primary 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.
Discussion: It 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 registration: Clinicaltrials.gov, NCT02866799
KW  - Family Physician
KW  - Primary Care Health Centre
KW  - Massive Online Open Course
KW  - Spanish National Health System
KW  - Medication Appropriateness Index
Y1  - 2017
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/46337
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-463375
SN  - 1748-5908
N1  - Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
VL  - 12
IS  - 1, Art. 54
SP  - 1
EP  - 10
PB  - BioMed Central
CY  - London
ER  -