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)

Prados-Torres, A. (Universidad de Zaragoza) ; del Cura-González, I. ; Prados-Torres, D. ; López-Rodríguez, J.A. ; Leiva-Fernández, F. ; Calderón-Larrañaga, A. ; López-Verde, F. ; Gimeno-Feliu, L.A. (Universidad de Zaragoza) ; Escortell-Mayor, E. ; Pico-Soler, V. ; Sanz-Cuesta, T. ; Bujalance-Zafra, M.J. ; Morey-Montalvo, M. ; Boxó-Cifuentes, J.R. ; Poblador-Plou, B. ; Fernández-Arquero, J.M. ; González-Rubio, F. (Universidad de Zaragoza) ; Ramiro-González, M.D. ; Coscollar-Santaliestra, C. (Universidad de Zaragoza) ; Martín-Fernández, J. ; Barnestein-Fonseca, M.P. ; Valderas-Martínez, J.M. ; Marengoni, A. ; Muth, C. ; Aza-Pascual-Salcedo, M. ; Poncel-Falcó, A. ; Bandrés-Liso, A.C. ; Alcaraz-Borrajo, M. ; Ruiz-San-Basilio, J.M. ; Mataix-San-Juan, A. ; López-León, A.M. ; Mateos-Sancho, C. ; Gimeno-Miguel, A. ; Hernández-Santiago, V. ; García de Blas, F. ; García-Agua, N. ; Rodríguez-Barrientos, R. ; Vázquez-Alarcón, R. ; Laguna-Berna, C. ; Márquez-Chamizo, M.I. ; Marta-Moreno, J. ; Azcoaga-Lorenzo, A. ; Abad-Díez, J.M. ; Sánchez-Perruca, L. ; Polentinos-Castro, E. ; Clerencia-Sierra, M. ; Ariza-Cardiel, G. ; González-González, A.I. ; Rico-Blázquez, M. ; Rogero-Blanco, M. ; Tello-Bernabé, M.E. ; Álvarez-Villalba, M. ; Rumayor-Zarzuelo, M. ; del Pozo, C.S.C. ; Torrente Garrido, J.I. (Universidad de Zaragoza) ; Aranda, C.G. ; Lafuente, M.P. ; Delgado Marroquín, Ma.Teresa (Universidad de Zaragoza) ; Molina, M.J.G. ; Bernal, J.C. ; Martín, M.V.A. ; Domínguez, S.G. ; Gorbea, C.B. ; Negre, A.L.O. ; Royo, E.G. ; Taira, M.B.A. ; Gutiérrez, J.F.T. ; Quintana, J.P. ; Miguel, V.M. ; de las Heras, E.M. ; Algora, C.E. ; de Letosa, M.T.M.N. ; Gascón del Prim, Elena ; Delgado, N.S. ; Sanjuan Cortés, Ma Rosario ; Sánchez, T.C. ; Lucas, E.D. ; Mínguez Sorio, M.P. ; Marzal, A.C. ; García, E.D. ; Álvarez, J.C.G. ; de Blas González, F.G. ; Pérez, C.G. ; Franco, A.L.G. ; Beneitez, M.E.V. ; Ballarín González, Ana ; Zapata, M.I.F. ; Suarez, E.G. ; Ortiz, F.M. ; Laguno, L.C.P. ; Gómez, J.L.Q. ; Pascual, E.R. ; López, F.R.A. ; Álvaro, C.C. ; González, P.C. ; Hamalainen, S.M.M. ; Fernández, R.M. ; Blanco, M.E.R. ; Arce, C.S. ; Wiesman, E.C. ; Galindo, J.O. ; Marcos, C.L. ; Borda, S.L. ; Fernández, J.C.M. ; Gómez, B.M. ; de Mingo, E.R. ; Pascual, J.P.C. ; Barroso, M.G. ; Serrano, B.L. ; Peláez, M.P.M. ; González, F.P. ; Salvador, J.S. ; Yépez, J.D.S. ; Alonso, A.S. ; Villalba, M.M.Á. ; Tapia, P.M. ; Alcántara, M.A.F. ; Alonso, M.C.H. ; González, R.I. ; Antón, M.A.M. ; Pérez, M.A.A. ; Lorenzo, A.A. ; Medina, R.D.F. ; Laguna, A.N.L. ; de Rivera, E.M.C. ; Flores, I.S. ; Rodríguez, M.J.S. ; Isabel, M.S.N. ; Sánchez, J.M.R. ; Llanos, P.S. ; Campillo, L.V. ; Izquierdo, J.M. ; Sainz, M.T. ; Jiménez, M.J.F. ; García, E.M. ; Navarro Jiménez, J.M. ; Gómez, D.G. ; Mendoza, L.G. ; de la Mota, Ybancos, Luz Pilar ; Genafo, J.S. ; Rodríguez, M.J.A. ; Garach, E.B. ; Arteaga, B.C.d. ; Parrilla, M.D.G. ; Sánchez Morales, Catalina ; Chasco, M.M.L. ; Ríos, I.M. ; Delgado, E.M. ; Aurioles, E.M. ; Ruiz, S.H. ; Escalante, N.M. ; Salido, E.L. ; Torres, M.A.M. ; Rodríguez, M.L.M. ; Gálvez, E.P. ; Torres, J.M.R. ; Fernández, C.T. ; Cañavate, M.D.G.M. ; Mellado, M.M.G. ; Pradilla, M.V.M. ; Peña, M.J.C. ; Fernández, J.L. ; Romero, V.C. ; Maqueda, R.Á. ; Valdés, G.A. ; Santaella, M.D. ; Vargas, A.M.F. ; García, I.G. ; Rod

Resumen: 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

Idioma: Inglés

DOI: 10.1186/s13012-017-0584-x

Año: 2017

Publicado en: Implementation Science 12, 1 (2017), 54 [10 pp]
ISSN: 1748-5908

Factor impacto JCR: 4.345 (2017)

Categ. JCR: HEALTH POLICY & SERVICES rank: 5 / 79 = 0.063 (2017) - Q1 - T1
Categ. JCR: HEALTH CARE SCIENCES & SERVICES rank: 10 / 94 = 0.106 (2017) - Q1 - T1

Factor impacto SCIMAGO: 2.443 - Health Informatics (Q1) - Public Health, Environmental and Occupational Health (Q1) - Medicine (miscellaneous) (Q1) - Health Policy (Q1)

Financiación: info:eu-repo/grantAgreement/EUR/ERDF/A way to build Europe
Financiación: info:eu-repo/grantAgreement/ES/ISCIII/FIS/PI15-00276
Financiación: info:eu-repo/grantAgreement/ES/ISCIII/FIS/PI15-00572
Financiación: info:eu-repo/grantAgreement/ES/ISCIII/FIS/PI15-00996
Financiación: info:eu-repo/grantAgreement/ES/REDISSEC/RD12-0001-0012
Financiación: info:eu-repo/grantAgreement/ES/REDISSEC/RD16-0001-0005

Tipo y forma: Article (Published version)

Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)
Área (Departamento): Área Medic.Prevent.Salud Públ. (Dpto. Microb.Med.Pr.,Sal.Públ.)