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
MetadataShow full item record
Altmetrics Handle Statistics
Altmetrics DOI Statistics
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
del Cura-González , I , López-Rodríguez , J A , Leiva-Fernández , F , Gimeno-Feliu , L A , Pico-Soler , V , Bujalance-Zafra , M J , Domínguez-Santaella , M , Polentinos-Castro , E , Poblador-Plou , B , Ara-Bardají , P , Aza-Pascual-Salcedo , M , Rogero-Blanco , M , Castillo-Jiménez , M , Lozano-Hernández , C , Gimeno-Miguel , A , González-Rubio , F , Medina-García , R , González-Hevilla , A , Gil-Conesa , M , Martín-Fernández , J , M. Valderas , J , Marengoni , A , Muth , C , Prados-Torres , J D , Prados-Torres , A , MULTIPAP PLUS Group , Azcoaga-Lorenzo , A & Hernandez Santiago , V 2022 , ' 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 ' , Trials , vol. 23 , 479 . https://doi.org/10.1186/s13063-022-06293-x
This 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. The Creative Commons Public Domain Dedication waiver (http://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.
DescriptionFunding: This study was funded by Instituto de Salud Carlos III (isciii) [file number PI18/01812, PI18/01303 y PI18/01515, RD16/0001/0004, RD16/0001/0005, RD16/0001/0006] and co-funded by the European Regional Development Fund ‘A way to shape Europe; Research, Development and Innovation National Plan 2013-2016’.
Items in the St Andrews Research Repository are protected by copyright, with all rights reserved, unless otherwise indicated.