A Hybrid Effectiveness-Implementation Trial of a Complex Multiple Risk Intervention to Promote Healthy Behaviors in People Between 45 to 75 Years Attended in Primary Health Care

Health promotion interventions are complex and need in-depth understanding of the context which is part of its effect. In this respect, the methodology proposed by the Medical Research Council offers a unique opportunity. This methodology proposes a development in five sequential phases in which both quantitative and qualitative methods are used, which include: a) definition of the theoretical basis (preclinical phase), b) modeling (phase I), c) exploratory trial (phase II), d) definitive randomized controlled trial (phase III) and e) long-term implementation (phase IV). This methodology promotes the participation of citizens and professionals in research and increases the acceptability and the feasibility of intervention. It is also an ideal tool to achieve the sustainability of interventions and the transfer of research to practice. Research on complex interventions marks a turning point in the conventional way of conducting experimental studies in which the most important thing is finding value and understanding the context of practice rather than trying to control its influence. Hybrid trials represent the ideal design because they allow a joint assessment of clinical effectiveness and implementation, thanks to their dual approach.

In this connection, the researchers started in 2012 the EIRA study and carried out the first three phases (preclinical phase, phase I and phase II). Currently, researchers are pursuing the phase III whose purpose is to assess the cost-effectiveness and the implementation of a health promotion intervention through a hybrid design.

This cluster randomized controlled trial aims to assess the effectiveness and the implementation of a complex multiple risk behavior intervention with two parallel groups (intervention and usual care). It is based on:

• The "Consolidated Framework for Implementation Research" (CFIR) which identifies five constructs: 1) intervention characteristics (intervention source, evidence strength and quality, relative advantage, adaptability, trialability, complexity, design quality and packaging; and cost); 2) outer setting (patient needs and resources, cosmopolitanism, peer pressure, and external policy and incentives); 3) inner setting (structural characteristics, networks and communications, culture, implementation climate and readiness for implementation); 4) characteristics of individuals (knowledge and beliefs about the intervention, self-efficacy, individual state of change, individual identification with the organization, and other personal attributes); and 5) the implementation process itself.
• A set of discrete implementation strategies which includes: plan strategies (gather information, adapt and pilot material and processes, build buy-in, initiate leadership and develop relationships); educate strategies (develop materials, educate, educate through peers, inform and influence stakeholders); finance strategies (modify incentives and facilitate financial support); restructure strategies (revise professional roles and create community and group interventions committees) and quality management strategies (develop and organize implementation monitoring systems, conduct continuous assessment and feedback, establish a system of reminders, obtain and use patient opinion, centralize technical assistance focused on implementation issues).
• An evaluation framework to determine the success of implementation.

The study will be carried out in three stages: