Complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in primary health care (EIRA study): study protocol for a hybrid trial

Edurne Zabaleta-Del-Olmo, Haizea Pombo, Mariona Pons-Vigués, Marc Casajuana-Closas, Enriqueta Pujol-Ribera, Tomás López-Jiménez, Carmen Cabezas-Peña, Carme Martín-Borràs, Antoni Serrano-Blanco, Maria Rubio-Valera, Joan Llobera, Alfonso Leiva, Caterina Vicens, Clara Vidal, Manuel Campiñez, Remedios Martín-Álvarez, José-Ángel Maderuelo, José-Ignacio Recio, Luis García-Ortiz, Emma Motrico, Juan-Ángel Bellón, Patricia Moreno-Peral, Carlos Martín-Cantera, Ana Clavería, Susana Aldecoa-Landesa, Rosa Magallón-Botaya, Bonaventura Bolíbar, Edurne Zabaleta-Del-Olmo, Haizea Pombo, Mariona Pons-Vigués, Marc Casajuana-Closas, Enriqueta Pujol-Ribera, Tomás López-Jiménez, Carmen Cabezas-Peña, Carme Martín-Borràs, Antoni Serrano-Blanco, Maria Rubio-Valera, Joan Llobera, Alfonso Leiva, Caterina Vicens, Clara Vidal, Manuel Campiñez, Remedios Martín-Álvarez, José-Ángel Maderuelo, José-Ignacio Recio, Luis García-Ortiz, Emma Motrico, Juan-Ángel Bellón, Patricia Moreno-Peral, Carlos Martín-Cantera, Ana Clavería, Susana Aldecoa-Landesa, Rosa Magallón-Botaya, Bonaventura Bolíbar

Abstract

Background: Health promotion is a key process of current health systems. Primary Health Care (PHC) is the ideal setting for health promotion but multifaceted barriers make its integration difficult in the usual care. The majority of the adult population engages two or more risk behaviours, that is why a multiple intervention might be more effective and efficient. The primary objectives are to evaluate the effectiveness, the cost-effectiveness and an implementation strategy of a complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in PHC.

Methods: This study is a cluster randomised controlled hybrid type 2 trial with two parallel groups comparing a complex multiple risk behaviour intervention with usual care. It will be carried out in 26 PHC centres in Spain. The study focuses on people between 45 and 75 years who carry out two or more of the following unhealthy behaviours: tobacco use, low adherence to the Mediterranean dietary pattern or insufficient physical activity level. The intervention is based on the Transtheoretical Model and it will be made by physicians and nurses in the routine care of PHC practices according to the conceptual framework of the "5A's". It will have a maximum duration of 12 months and it will be carried out to three different levels (individual, group and community). Incremental cost per quality-adjusted life year gained measured by the tariffs of the EuroQol-5D questionnaire will be estimated. The implementation strategy is based on the "Consolidated Framework for Implementation Research", a set of discrete implementation strategies and an evaluation framework.

Discussion: EIRA study will determine the effectiveness and cost-effectiveness of a complex multiple risk intervention and will provide a better understanding of implementation processes of health promotion interventions in PHC setting. It may contribute to increase knowledge about the individual and structural barriers that affect implementation of these interventions and to quantify the contextual factors that moderate the effectiveness of implementation.

Trial registration: ClinicalTrials.gov , NCT03136211 .Retrospectively registered on May 2, 2017.

Keywords: Complex interventions; Cost-effectiveness analysis; Health behaviour; Health promotion; Hybrid trial; Implementation research; Mediterranean diet; Physical activity; Primary health care; Smoking.

Conflict of interest statement

Ethics approval and consent to participate

This protocol and the template informed consent forms were reviewed and approved by the Research Ethics Committee of the IDIAP Jordi Gol (approval number P16/025). PHC professionals will introduce the study to participants and will obtain written consent from people willing to participate in the trial. The study will comply with all applicable laws on the protection of personal data. All data collection forms will be identified by a coded ID [identification] number only to maintain participant confidentiality.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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