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

DOI: 10.1186/s13063-022-06293-x

Isabel del Cura-González, Juan A. López-Rodríguez, Francisca Leiva-Fernández, Luis A. Gimeno-Feliu, Victoria Pico-Soler, Mª. Josefa Bujalance-Zafra, Miguel Domínguez-Santaella, Elena Polentinos-Castro, Beatriz Poblador-Plou, Paula Ara-Bardají, Mercedes Aza-Pascual-Salcedo, Marisa Rogero-Blanco, Marcos Castillo-Jiménez, Cristina Lozano-Hernández, Antonio Gimeno-Miguel, Francisca González-Rubio, Rodrigo Medina-García, Alba González-Hevilla, Mario Gil-Conesa, Jesús Martín-Fernández, José M. Valderas, Alessandra Marengoni, Christiane Muth, J. Daniel Prados-Torres, MULTIPAP PLUS Group

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.

Keywords: Cluster randomized controlled trial; Computer-assisted; Decision-making; Medication reconciliation; Multimorbidity; Patient-centred care; Polypharmacy; Primary health care.