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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

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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9178530/
https://www.ncbi.nlm.nih.gov/pubmed/35681224
http://dx.doi.org/10.1186/s13063-022-06293-x
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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
author_facet 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
author_sort del Cura-González, Isabel
collection PubMed
description 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 (≥ 3 chronic diseases) and polypharmacy (≥ 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 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06293-x.
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spelling pubmed-91785302022-06-09 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 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 Trials Study Protocol 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 (≥ 3 chronic diseases) and polypharmacy (≥ 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 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06293-x. BioMed Central 2022-06-09 /pmc/articles/PMC9178530/ /pubmed/35681224 http://dx.doi.org/10.1186/s13063-022-06293-x Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
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
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9178530/
https://www.ncbi.nlm.nih.gov/pubmed/35681224
http://dx.doi.org/10.1186/s13063-022-06293-x
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