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Randomized Controlled Trial
. 2017 Apr 27;12(1):54.
doi: 10.1186/s13012-017-0584-x.

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)

Alexandra Prados-Torres  1   2   3   4 , Isabel Del Cura-González  5   6   7 , Daniel Prados-Torres  8   9   10 , Juan A López-Rodríguez  5   6   7   11 , Francisca Leiva-Fernández  8   9   10 , Amaia Calderón-Larrañaga  12   5   13   14 , Fernando López-Verde  15 , Luis A Gimeno-Feliu  16   5   17 , Esperanza Escortell-Mayor  5   6 , Victoria Pico-Soler  5   18 , Teresa Sanz-Cuesta  5   6 , Mª Josefa Bujalance-Zafra  19 , Mariel Morey-Montalvo  5   6 , José Ramón Boxó-Cifuentes  20 , Beatriz Poblador-Plou  12   5   13 , José Manuel Fernández-Arquero  21 , Francisca González-Rubio  5   22 , María D Ramiro-González  23 , Carlos Coscollar-Santaliestra  5   17 , Jesús Martín-Fernández  5   7   24 , Mª Pilar Barnestein-Fonseca  9   10 , José María Valderas-Martínez  25 , Alessandra Marengoni  26 , Christiane Muth  27 ; Multi-PAP Group
Collaborators, Affiliations
Randomized Controlled Trial

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)

Alexandra Prados-Torres et al. Implement Sci. .

Abstract

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 12 months, 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 65-74 years with multimorbidity (≥3 chronic diseases) and polypharmacy (≥5 drugs prescribed in ≥3 months).

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.

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Complex intervention pat plot. QoL quality of life, MOOC Massive Online Open Courses
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