학술논문
Effectiveness of the MULTIPAP Plus intervention in youngest-old patients with multimorbidity and polypharmacy aimed at improving prescribing practices in primary care: study protocol of a cluster randomized trial
Document Type
Report
Author
del Cura-González, Isabel; López-Rodríguez, Juan A.; Leiva-Fernández, Francisca; Gimeno-Feliu, Luis A.; Pico-Soler, Victoria; Bujalance-Zafra, Mª. Josefa; Domínguez-Santaella, Miguel; Polentinos-Castro, Elena; Poblador-Plou, Beatriz; Ara-Bardají, Paula; Aza-Pascual-Salcedo, Mercedes; Rogero-Blanco, Marisa; Castillo-Jiménez, Marcos; Lozano-Hernández, Cristina; Gimeno-Miguel, Antonio; González-Rubio, Francisca; Medina-García, Rodrigo; González-Hevilla, Alba; Gil-Conesa, Mario; Martín-Fernández, Jesús; Valderas, José M.; Marengoni, Alessandra; Muth, Christiane; Prados-Torres, J. Daniel; Prados-Torres, Alexandra; Orellana-Lozano, Francisco Javier; Sepúlveda-Muéoz, Jesús; Sánchez-Jordán, Rafael; Escobar-Pérez, Amparo; Rodríguez-García, Concepción; Peéuela-Ruiz, Trinidad; Navarro-Martín, José Antonio; Rodríguez-Rivera, María Rosario; Aguilar-Heredia, Yolanda; Martínez-Sarmiento, Antonio Ignacio; Pascual-de-la-Pisa, Beatriz; García-Lozano, María José; García-Carrera, Alejandro; Juan-Tordesillas, Noelia; Márquez-Chamizo, María Isabel; Navarro-Jiménez, José Manuel; Ruiz-Ciudad, María Carmen; Vázquez-Alarcón, Rubén Luciano; Navarro-Gallego, María Isabel; Ginel-Mendoza, Leovigildo; Ruiz-San-Basilio, José María; Barceló-Garach, Elena; Alcantarilla-Reyes, Elisa María; de Cienfuegos Hernández, Marta Ãlvarez; Martínez-Ríos, Irene; Orellana-Martín, Laura; Merino-Moyano, María Dolores; Segura-Domínguez, Nuria; Moral-Merchán, María Cristina; Martín-Aurioles, Esther; Rodríguez-González, María Inmaculada; Hazaéas-Ruiz, Sylvia; Gallego-Castillo, Eva Noelia; Mora-García, Esperanza; Cámara-Sola, Estefanía; Fons-Caéizares, Sergio; Ortigosa-Arrabal, María Paz; Quesada-Fernández, Teresa; Rodríguez-Moreno, Silvia; Sánchez-Silvestre, Ana; Torrubia-Fernández, María Jesús; González-Vega, María José; Almagro-Martín-Lomeéa, María Victoria; Serrano-González, Caridad; Leiva-Fernández, José; Castillo-Romero, Virginia; Fernández-Vargas, Ana María; Serrano-Guerra, Francisco José; Narbona-Carrión, Gabriel Francisco; Michel-Bertevas, Hervé; Maqueda, Rafael Ãngel; García-Agua-Soler, Nuria; del Pilar Barnestein-Fonseca, Maria; Abadía-Taira, María Begoéa; Sánchez-Celaya-del-Pozo, Carmen; Giménez-Baratech, Ana Carmen; Sanz-Burgos, Lara; Abad-Royo, Mercedes; Camats-Franco, Carmen; Cortés-Pellicer, José Manuel; Herrero-Solsona, Paula; Moreno-Juste, Aida; Guiu-Campos, Miguel; Peyman-Fard-Shafi-Tabatabaei, Nima; Delgado-Marroquín, Ma Teresa; López-Echevarría, Mercedes; Carmona-Pírez, Jonás; Barrera-Linares, Fernando; Carrillo-Soria, Sandro Daniel; Esteban-Gimeno, Ana Belén; López-Alonso, Beatriz; Hernández-Bono, Anabel; Martínez-Ayala, Enrique; Martínez-Manero, Adriana; Martínez-Sánchez, Raquel; Naya-Mateu, Yolanda; Clemente-Jiménez, María Lourdes; Leon-Martínez, María Paz; Mahuela, Liliana; Sanjuan-Cortés, Ma Rosario; Salazar-González, Elisa Pilar; Charte-Alegre, Ma Elena; Mur-Lazuela, Ma Jesús; Pascual-Franco, Mónica; Arizon-Deza, Pilar; García-Gutiérrez-Muéoz, Carmen; García-Ruiz, Teresa; Navarro-Aznárez, Gloria; Alcober-Pérez, Carlos; Navarro-Tausiet, María Paz; Lacasa-Serrano, Ma Elena; Maza-Invernón, Ana Cristina; Peleato-Sánchez, Jaime; Buéuel-Granados, José Miguel; Alonso-Valbuena, Ainara; Lasheras-Barrio, Mónica; Ibarrondo-Fernández-Ladreda, Isabel; López-Aylon, Rosa Ma; Rodríguez-Fabre, María José; Rubio-Gutiérrez, Isabel; Valverde-Aranda, Selma; Bandrés-Liso, Ana Cristina; Poncel-Falcó, Antonio; Bliek-Bueno, Kevin; Cano-del-Pozo, Mabel; Clerencia-Sierra, Mercedes; Díez-Manglano, Jesús; Guerrero-Fernández-de-Alba, Inmaculada; Ioakeim-Skoufa, Ignatios; Marta-Moreno, Javier; Santos-Muéoz, David; Viéuela-Benéitez, María Elisa; Miguel-Abanto, María De Los Angeles; García-De-Blas, Francisca; García-Ãlvarez, Juan Carlos; Redondo-de-Pedro, Sonia; González-García, Carlos Fernando; Peláez-Laguno, Carolina; Gomez-Suarez, Esther; Morales-Ortiz, Fernanda; Ferrer-Zapata, Isabel; Sánchez-Fernández, Yolanda Beatriz; Fernández-Fernández, Yolanda; Barrio-Higelmo, Esther; Rioja-Delgado, Eva María; Lopez-Larrayoz, Irina; Seara-Lozano, María Luz; Fernández-Sánchez, Julio Cesar; San-Miguel-Marinero, María Teresa; Fidalgo-Baz, María Jesus; Ares-Blanco, Sara; Gómez-Ciriano, Jorge Ignacio; Garcés-Ranz, José Damián; Santos-Franco, Laura; García-Galeano, María Celeste; Mateo-Fernández, Raquel; Morcillo-Cebolla, Sara; Rossignoli-Fernández, Tomás; Olmedo-Galindo, Jorge; Pinel-González, Marta; Redondo-Romero, Rosa María; Estrada-Leon, Adnaloy Helena; Muéoz-Gómez, Belén; Sanz-Pozo, Blanca; López-Marcos, Claudia; Rodríguez-De-Mingo, Enrique; Moreno-Fernández, Juan Carlos; Morales-Cobos, Luis Enrique; Garcia-Garcia-Alcaéiz, María Del Prado; Lorenzo-Borda, Marisol; González-García, Vera; Muéoz-Molina, María Del Pilar; Drak-Hernández, Yasmin; Rabanal-Basalo, Alejandro; Abad-Esteban, Ana María; Rollan-Hernández, María De Los Ãngeles; Fuster-Tozer, Mónica; Carretero-Ramos, Raquel; Mielgo-Salvador, Rebeca; Sosa-Alonso, Ana; Muros-Muéoz, Carmen María; Sánchez-Yépez, Jeannet Dolores; Cáceres-Cortés, María Cristina; Morso-Peláez, María Paloma; Pastor-Estebanez, María; Fernández-Girón, Mercedes; Pérez-De-Colosia-Zuil, Antonia; Pérez-Gutiérrez, Esteban; Tejero-García, Isabel; Innerarity-Martínez, Jaime; Ãlvarez-Villalba, Mar; Gómez-Barroso, Margarita; Escobar-Gallegos, María Del Mar; Bedoya-Frutos, María Jesus; Del-Olmo-Ribagorda, Marta Inmaculada; Cortés-Durán, Petra María; Tardáguila-Lobato, Pilar; Terrón-Barbosa, Raquel Yolanda; Ramos-Blanco, Antonio; López-Villalvilla, Aránzazu; Cinta-Bella, Beatriz; Varela-Varela, Cristian; Garcia-Rodriguez, Francisca; Saiz-Ladera, Gema María; López-Fernández, Guillermina; Orozco-Barrenechea, Lourdes; Zafra-De-Gea, María Begoéa; García-Arpa, Nuria; Ewa-Barnas, Tamara; Carbonero-Martín, Ana Isabel; Rojas-Giraldo, María José; Cotillas-Rodero, Alberto; López-Serrano, Beatriz; Rodriguez-Fernández, María Del Carmen; Sanz-Velasco, Carmelina; Aza-Pascual-Salcedo, Jose Ignacio; Lopez-Olmeda, Carolina; Gutiérrez-Ocana, Estrella; García-Ocaéa, Raquel; Sanz-Cuesta, Teresa; Rodríguez-Barrientos, Ricardo; Rico-Blázquez, Milagros; Ariza-Cardiel, Ma Gloria; Mataix-San-Juan, Angel; Alcaraz-Borrajo, Marta; Rumayor-Zarzuelo, Mercedes; Sánchez-Perruca, Luis; Azcoaga-Lorenzo, Amaya; Hernández-Santiago, Virginia; Rotaeche-del-Campo, Rafael
Source
Trials. June 9, 2022, Vol. 23 Issue 1
Subject
Language
English
ISSN
1745-6215
Abstract
Author(s): Isabel del Cura-González[sup.1,2,3,4,5] , Juan A. López-Rodríguez[sup.1,2,3,4,5,6] , Francisca Leiva-Fernández[sup.3,5,7,8,9] , Luis A. Gimeno-Feliu[sup.3,5,10,11,12] , Victoria Pico-Soler[sup.3,5,12,13] , Mª. Josefa Bujalance-Zafra[sup.7,14] , Miguel Domínguez-Santaella[sup.7,14] , Elena Polentinos-Castro[sup.1,2,3,4,5] , Beatriz [...]
Background The progressive ageing of the population is leading to an increase in multimorbidity and polypharmacy, which in turn may increase the risk of hospitalization and mortality. The enhancement of care with information and communications technology (ICT) can facilitate the use of prescription evaluation tools and support system for decision-making (DSS) with the potential of optimizing the healthcare delivery process. Objective To assess the effectiveness and cost-effectiveness of the complex intervention MULTIPAP Plus, compared to usual care, in improving prescriptions for young-old patients (65-74 years old) with multimorbidity and polypharmacy in primary care. Methods/design This is a pragmatic cluster-randomized clinical trial with a follow-up of 18 months in health centres of the Spanish National Health System. Unit of randomization: family physician. Unit of analysis: patient. Population Patients aged 65-74 years with multimorbidity ([greater than or equai to] 3 chronic diseases) and polypharmacy ([greater than or equai to] 5 drugs) during the previous 3 months were included. Sample size n = 1148 patients (574 per study arm). Intervention Complex intervention based on the ARIADNE principles with three components: (1) family physician (FP) training, (2) FP-patient interview, and (3) decision-making support system. Outcomes The primary outcome is a composite endpoint of hospital admission or death during the observation period measured as a binary outcome, and the secondary outcomes are number of hospital admission, all-cause mortality, use of health services, quality of life (EQ-5D-5L), functionality (WHODAS), falls, hip fractures, prescriptions and adherence to treatment. Clinical and sociodemographic factors will be explanatory variables. Statistical analysis The main result is the difference in percentages in the final composite endpoint variable at 18 months, with its corresponding 95% CI. Adjustments by the main confounding and prognostic factors will be performed through a multilevel analysis. All analyses will be carried out in accordance to the intention-to-treat principle. Discussion It is important to prevent the cascade of negative health and health care impacts attributable to the multimorbidity-polypharmacy binomial. ICT-enhanced routine clinical practice could improve the prescription process in patient care. Trial registration ClinicalTrials.gov NCT04147130. Registered on 22 October 2019 Keywords: Multimorbidity, Patient-centred care, Polypharmacy, Medication reconciliation, Decision-making, Computer-assisted, Primary health care, Cluster randomized controlled trial
Background The progressive ageing of the population is leading to an increase in multimorbidity and polypharmacy, which in turn may increase the risk of hospitalization and mortality. The enhancement of care with information and communications technology (ICT) can facilitate the use of prescription evaluation tools and support system for decision-making (DSS) with the potential of optimizing the healthcare delivery process. Objective To assess the effectiveness and cost-effectiveness of the complex intervention MULTIPAP Plus, compared to usual care, in improving prescriptions for young-old patients (65-74 years old) with multimorbidity and polypharmacy in primary care. Methods/design This is a pragmatic cluster-randomized clinical trial with a follow-up of 18 months in health centres of the Spanish National Health System. Unit of randomization: family physician. Unit of analysis: patient. Population Patients aged 65-74 years with multimorbidity ([greater than or equai to] 3 chronic diseases) and polypharmacy ([greater than or equai to] 5 drugs) during the previous 3 months were included. Sample size n = 1148 patients (574 per study arm). Intervention Complex intervention based on the ARIADNE principles with three components: (1) family physician (FP) training, (2) FP-patient interview, and (3) decision-making support system. Outcomes The primary outcome is a composite endpoint of hospital admission or death during the observation period measured as a binary outcome, and the secondary outcomes are number of hospital admission, all-cause mortality, use of health services, quality of life (EQ-5D-5L), functionality (WHODAS), falls, hip fractures, prescriptions and adherence to treatment. Clinical and sociodemographic factors will be explanatory variables. Statistical analysis The main result is the difference in percentages in the final composite endpoint variable at 18 months, with its corresponding 95% CI. Adjustments by the main confounding and prognostic factors will be performed through a multilevel analysis. All analyses will be carried out in accordance to the intention-to-treat principle. Discussion It is important to prevent the cascade of negative health and health care impacts attributable to the multimorbidity-polypharmacy binomial. ICT-enhanced routine clinical practice could improve the prescription process in patient care. Trial registration ClinicalTrials.gov NCT04147130. Registered on 22 October 2019 Keywords: Multimorbidity, Patient-centred care, Polypharmacy, Medication reconciliation, Decision-making, Computer-assisted, Primary health care, Cluster randomized controlled trial