Abstract
BackgroundHealth 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.MethodsThis 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.DiscussionEIRA 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 registrationClinicalTrials.gov, NCT03136211.Retrospectively registered on May 2, 2017.
Highlights
Health promotion is a key process of current health systems
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
It is estimated that around 80% of cardiovascular diseases and 30% of all cancers could be prevented with the adoption of healthy behaviours: a major portion of these diseases is closely related to smoking, unhealthy diet, sedentary lifestyle, and excessive use of alcohol [1]
Summary
Design This study is a randomised controlled hybrid type 2 trial with two parallel groups which aims to test a complex multiple risk behaviour intervention of a maximum duration of 12 months and an implementation strategy simultaneously [18]. The protocol of hybrid trial has been written according to the Standards Protocol Items: Recommendations for Interventional Trials (SPIRIT) [26] and the Standards for Reporting Implementation studies (StaRI) [27]. Health promotion and community care are included in the basic PHC services; there are multiple barriers, like work overload and lack of time or training, that hinder their implementation [8, 9, 29,30,31]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
