Complex multiple risk intervention topromote healthy behaviours in peoplebetween 45 to 75 years attended inprimary health care (EIRA study): study protocol for a hybrid trial

Abstract

Background:Health promotion is a key process of current health systems. Primary Health Care (PHC) is the idealsetting for health promotion but multifaceted barriers make its integration difficult in the usual care. The majority ofthe adult population engages two or more risk behaviours, that is why a multiple intervention might be moreeffective and efficient. The primary objectives are to evaluate the effectiveness, the cost-effectiveness andan implementation strategy of a complex multiple risk intervention to promote healthy behaviours in peoplebetween 45 to 75 years attended in PHC.Methods:This study is a cluster randomised controlled hybrid type 2 trial with two parallel groups comparing acomplex multiple risk behaviour intervention with usual care. It will be carried out in 26 PHC centres in Spain. Thestudy focuses on people between 45 and 75 years who carry out two or more of the following unhealthybehaviours: 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 theroutine care of PHC practices according to the conceptual framework of the“5A’s”. It will have a maximum durationof 12 months and it will be carried out to three different levels (individual, group and community). Incremental costper quality-adjusted life year gained measured by the tariffs of the EuroQol-5D questionnaire will be estimated. Theimplementation strategy is based on the“Consolidated Framework for Implementation Research”, a set of discreteimplementation strategies and an evaluation framework. Discussion:EIRA study will determine the effectiveness and cost-effectiveness of a complex multiple riskintervention and will provide a better understanding of implementation processes of health promotioninterventions in PHC setting. It may contribute to increase knowledge about the individual and structural barriersthat affect implementation of these interventions and to quantify the contextual factors that moderate theeffectiveness of implementation.