1. 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)
- Author
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Prados Torres, Alexandra, del Cura González, Isabel, Prados Torres, Daniel, López Rodríguez, Juan A., Leiva Fernández, Francisca, Calderón Larrañaga, Amaia, López Verde, Fernando, Gimeno Feliu, Luis A., Escortell Mayor, Esperanza, Pico Soler, Victoria, Sanz Cuesta, Teresa, Bujalance Zafra, M. Josefa, Morey Montalvo, Mariel, Boxó Cifuentes, José Ramón, Poblador Plou, Beatriz, Fernández Arquero, José Manuel, González Rubio, Francisca, Ramiro González, María D., Coscollar Santaliestra, Carlos, Martín Fernández, Jesús, Barnestein Fonseca, M. Pilar, Valderas Martínez, José María, Marengoni, Alessandra, Muth, Christiane, Aza Pascual Salcedo, Mercedes, Poncel Falcó, Antonio, Bandrés Liso, Ana Cristina, Alcaraz Borrajo, Marta, Ruiz San Basilio, José Ma, Mataix San Juan, Ángel, López León, Ana Ma, Mateos Sancho, Carmina, Gimeno Miguel, Antonio, Hernández Santiago, Virginia, García de Blas, Francisca, García Agua, Nuria, Rodríguez Barrientos, Ricardo, Vázquez Alarcón, Rubén, Laguna Berna, Clara, Márquez Chamizo, Maria Isabel, Marta Moreno, Javier, Azcoaga Lorenzo, Amaya, Abad Díez, José María, Sánchez Perruca, Luis, Polentinos Castro, Elena, Clerencia Sierra, Mercedes, Ariza Cardiel, Gloria, González González, Ana Isabel, Rico Blázquez, Milagros, Rogero Blanco, Marisa, Tello Bernabé, Ma Eugenia, álvarez Villalba, Mar, Rumayor Zarzuelo, Mercedes, del Pozo, Carmen Sánchez Celaya, Garrido, José Ignacio Torrente, Aranda, Concepción García, Lafuente, Marina Pinilla, Ma Teresa Delgado Marroquín, Null, Molina, Ma José Gracia, Bernal, Javier Cuartero, Martín, Ma Victoria Asín, Domínguez, Susana García, Gorbea, Carlos Bolea, Negre, Antonio Luis Oto, Royo, Eugenio Galve, Taira, Ma Begoña Abadía, Gutiérrez, José Fernando Tomás, Quintana, José Porta, Miguel, Valentina Martín, de las Heras, Esther Mateo, Algora, Carmen Esteban, de Letosa, Ma Teresa Martín Nasarre, Elena Gascón del Prim, Null, Delgado, Noelia Sorinas, Ma Rosario Sanjuan Cortés, Null, Sánchez, Teodoro Corrales, Lucas, Eustaquio Dendarieta, Mínguez Sorio, Ma del Pilar, Marzal, Adolfo Cajal, García, Eduardo Díaz, Álvarez, Juan Carlos García, De Blas González, Francisca García, Pérez, Cristina Guisado, Franco, Alberto López García, Beneitez, Ma Elisa Viñuela, Ana Ballarín González, Null, Zapata, Ma Isabel Ferrer, Suarez, Esther Gómez, Ortiz, Fernanda Morales, Laguno, Lourdes Carolina Peláez, Gómez, José Luis Quintana, Pascual, Enrique Revilla, López, Francisco Ramón Abellán, Álvaro, Carlos Casado, González, Paulino Cubero, Hamalainen, Santiago Manuel Machín, Fernández, Raquel Mateo, Blanco, Ma Eloisa Rogero, Arce, Cesar Sánchez, Wiesman, Elisa Ceresuela, Galindo, Jorge Olmedo, Marcos, Claudia López, Borda, Soledad Lorenzo, Fernández, Juan Carlos Moreno, Gómez, Belén Muñoz, De Mingo, Enrique Rodríguez, Pascual, Juan Pedro Calvo, Barroso, Margarita Gómez, Serrano, Beatriz López, Peláez, Ma Paloma Morso, González, Fernando Perales, Salvador, Julio Sánchez, Yépez, Jeannet Dolores Sánchez, Alonso, Ana Sosa, Villalba, Ma del Mar Álvarez, Tapia, Purificación Magán, Alcántara, Ma Angelica Fajardo, Alonso, Ma Canto De Hoyos, González, Rosario Iglesias, Antón, Ma Aránzazu Murciano, Pérez, Manuel Antonio Alonso, Lorenzo, Amaya Azcoaga, Medina, Ricardo De Felipe, Laguna, Amaya Nuria López, De Rivera, Eva Martínez Cid, Flores, Iliana Serrano, Rodríguez, Ma Jesús Sousa, Isabel, Ma Soledad Núñez, Sánchez, Jesús Ma Redondo, Llanos, Pedro Sánchez, Campillo, Lourdes Visedo, Izquierdo, Javier Martín, Sainz, Macarena Toro, Jiménez, Ma José Fernández, García, Esperanza Mora, Navarro Jiménez, José Manuel, Gómez, Deborah Gil, Mendoza, Leovigildo Ginel, Luz Pilar de la Mota Ybancos, Null, Genafo, Jaime Sasporte, Rodríguez, Ma José Alcaide, Garach, Elena Barceló, Arteaga, Beatriz Caffarena de, Parrilla, Ma Dolores Gallego, Catalina Sánchez Morales, Null, Chasco, Ma del Mar Loubet, Ríos, Irene Martínez, Delgado, Elena Mateo, Aurioles, Esther Martín, Ruiz, Sylvia Hazañas, Escalante, Nieves Muñoz, Salido, Enrique Leonés, Torres, Ma Antonia Máximo, Rodríguez, Ma Luisa Moya, Gálvez, Encarnación Peláez, Torres, José Manuel Ramírez, Fernández, Cristóbal Trillo, Cañavate, Ma Dolores García Martínez, Mellado, Ma del Mar Gil, Pradilla, Ma Victoria Muñoz, Peña, Ma José Clavijo, Fernández, José Leiva, Romero, Virginia Castillo, Maqueda, Rafael Ángel, Valdés, Gloria Aycart, Santaella, Miguel Domínguez, Vargas, Ana Ma Fernández, García, Irene García, Rodríguez, Antonia González, Mendaño, Ma Carmen Molina, Naranjo, Juana Morales, Torres, Catalina Moreno, Guerra, Francisco Serrano, University of St Andrews. School of Medicine, and Multi-PAP Group
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Male ,law.invention ,Health administration ,Study Protocol ,0302 clinical medicine ,Medication appropriateness index ,Randomized controlled trial ,law ,Patient-Centered Care ,Health care ,Outcome Assessment, Health Care ,Medicine ,030212 general & internal medicine ,Medicine(all) ,Aged, 80 and over ,lcsh:R5-920 ,education.field_of_study ,Massive Online Open Course ,Medicine (all) ,Health Policy ,Health services research ,General Medicine ,T-DAS ,Female ,Public Health ,lcsh:Medicine (General) ,Medication Appropriateness Index ,medicine.medical_specialty ,RM ,Population ,Primary Care Health Centre ,Health Informatics ,Drug Prescriptions ,03 medical and health sciences ,Outcome Assessment (Health Care) ,Quality of life (healthcare) ,SDG 3 - Good Health and Well-being ,Family Physician ,Humans ,ddc:610 ,Medical prescription ,education ,Aged ,Polypharmacy ,Primary care health centre ,Primary Health Care ,business.industry ,Family physician ,Environmental and Occupational Health ,Public Health, Environmental and Occupational Health ,Multimorbidity ,Spanish National Health System ,RM Therapeutics. Pharmacology ,Massive online open course ,Spain ,Family medicine ,Chronic Disease ,business ,030217 neurology & neurosurgery - Abstract
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"). 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 Publisher PDF
- Published
- 2017