TY - JOUR
T1 - Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy
T2 - Study protocol of a cluster randomized clinical trial (Multi-PAP project)
AU - Prados-Torres, Alexandra
AU - del Cura-González, Isabel
AU - Prados-Torres, Daniel
AU - López-Rodríguez, Juan A.
AU - Leiva-Fernández, Francisca
AU - Calderón-Larrañaga, Amaia
AU - López-Verde, Fernando
AU - Gimeno-Feliu, Luis A.
AU - Escortell-Mayor, Esperanza
AU - Pico-Soler, Victoria
AU - Sanz-Cuesta, Teresa
AU - Bujalance-Zafra, M. Josefa
AU - Morey-Montalvo, Mariel
AU - Boxó-Cifuentes, José Ramón
AU - Poblador-Plou, Beatriz
AU - Fernández-Arquero, José Manuel
AU - González-Rubio, Francisca
AU - Ramiro-González, María D.
AU - Coscollar-Santaliestra, Carlos
AU - Martín-Fernández, Jesús
AU - Barnestein-Fonseca, M. Pilar
AU - Valderas-Martínez, José María
AU - Marengoni, Alessandra
AU - Muth, Christiane
AU - Gimeno-Miguel, Antonio
AU - Hernández-Santiago, Virginia
AU - García-de Blas, Francisca
AU - García-Agua, Nuria
AU - Rodríguez-Barrientos, Ricardo
AU - Vázquez-Alarcón, Rubén
AU - Laguna-Berna, Clara
AU - Marta-Moreno, Javier
AU - Azcoaga-Lorenzo, Amaya
AU - Abad-Díez, José María
AU - Sánchez-Perruca, Luis
AU - Polentinos-Castro, Elena
AU - Clerencia-Sierra, Mercedes
AU - Ariza-Cardiel, Gloria
AU - González-González, Ana Isabel
AU - Rico-Blázquez, Milagros
AU - Rogero-Blanco, Marisa
AU - Tello-Bernabé, Ma Eugenia
AU - álvarez-Villalba, Mar
AU - Rumayor-Zarzuelo, Mercedes
AU - del Pozo, Carmen Sánchez Celaya
AU - Garrido, José Ignacio Torrente
AU - Aranda, Concepción García
AU - Lafuente, Marina Pinilla
AU - Ma Teresa Delgado Marroquín, Teresa Delgado Marroquín
AU - Molina, Ma José Gracia
AU - and Multi-PAP Group
N1 - This study was funded by the Fondo de Investigaciones Sanitarias ISCIII (Grant Numbers PI15/00276, PI15/00572, PI15/00996), REDISSEC (Project Numbers RD12/0001/0012, RD16/0001/0005), and the European Regional Development Fund ("A way to build Europe").
PY - 2017/4/27
Y1 - 2017/4/27
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 12months, 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 65-74years with multimorbidity (≥3 chronic diseases) and polypharmacy (≥5 drugs prescribed in ≥3months). 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
AB - 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 12months, 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 65-74years with multimorbidity (≥3 chronic diseases) and polypharmacy (≥5 drugs prescribed in ≥3months). 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
UR - http://www.scopus.com/inward/record.url?scp=85018303932&partnerID=8YFLogxK
U2 - 10.1186/s13012-017-0584-x
DO - 10.1186/s13012-017-0584-x
M3 - Article
C2 - 28449721
AN - SCOPUS:85018303932
SN - 1748-5908
VL - 12
SP - 1
EP - 10
JO - Implementation Science
JF - Implementation Science
IS - 1
M1 - 54
ER -