Complex Multiple Risk Behavior Intervention in People Between 45 to 75 Years (EIRA Study)
Condition: Health Behavior; Health Promotion; Primary Health Care; Implementation Research; Smoking Cessation; Mediterranean Diet; Physical Activity
Study type: Interventional

Summary: 
      This study examines the effectiveness and the costs of a complex multiple risk behavior
      intervention to promote healthy behaviors in people aged between 45 and 75 years attended in
      Primary Health Care services. This intervention aims to reduce tobacco use, to enhance
      adherence to the Mediterranean dietary pattern and to increase physical activity. The study
      also seeks to provide evidence on the strategies to integrate health promotion into the usual
      clinical practice of primary care providers.
    

Detailed description: 
      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:

      STAGE 1: PRE-IMPLEMENTATION. During this stage, the researchers will assess local needs and
      resources to develop specific implementation strategies. Likewise, the scientific literature
      will be reviewed and the perspectives of clinicians on the internal resources will be
      measured by the "Survey of Organizational Attributes for Primary Care". All the support
      material for the intervention will be drawn up, besides the facilitator (member of the
      research team) and the leader (member of the primary care team) of the implementation will be
      designated. Mechanisms for the effective communication and the case report form (CRF) will be
      defined and piloted. Formal compromises will be made with the managers (at the macro, meso
      and micro levels) and with the professionals involved. Training activities will be carried
      out in which training in motivational interview will have a central role. In addition, a
      checklist (on-line database) will be developed and piloted to monitor the progress of
      implementation in each primary care center.

      STAGE 2: IMPLEMENTATION. In this stage the implementation plan will be carried out. The
      facilitator and the leader of implementation will monitor the implementation processes,
      identify opportunities for improvement and optimize implementation. Likewise, positive
      feedback techniques will be used towards the main stakeholders in order to keep the agreed
      compromise and the motivation. Besides, health professionals will receive continuous training
      in motivational interview.

      STAGE 3: POST-IMPLEMENTATION.

      The evaluation of the implementation will be carried out through qualitative and quantitative
      research. It will be evaluated in terms of:

      A) OUTCOMES (see section "Outcome Measures"). B) DETERMINANTS. Three focus groups (one of
      health professionals and two of participants) will be conducted in each health center.
      Sampling will be theoretical (discursive plurality). Sessions will be transcribed in an
      anonymous fashion. A thematic content analysis will be done. The CFIR constructs will be
      scored following standard criteria that they will reflect the influence of the construct on
      the implementation (positive or negative) and its magnitude (between 1 and 2).

      C) LEVEL OF DEVELOPMENT. The level of development of each of the implementation strategies
      will be determined from the online database. Updating of this database will be carried out by
      the facilitator of implementation. Likewise, logistic regression models will be developed in
      which the dependent variable will be the effectiveness of the intervention, considered as a
      positive change in any of the three behaviors studied. In one of the models the independent
      variables will be the quantitative measures of the results of the implementation and in the
      other, the degree of implementation of the different strategies. The purpose of these
      analyzes is to model the relationship between the implementation variables and those of
      effectiveness. On the other hand, the influence and the magnitude of the determinants of the
      implementation and the results will be established through multivariate models.

      SAMPLE SIZE It will be necessary to study a minimum of 3640 people (1820 for each of the two
      groups). This sample size will allow to detect an increase of 8% in the proportion of people
      who show a positive change in one or more of the three behaviors in the intervention group
      over control group. The proportion of losses during follow-up estimated was of 30%. The
      sample size was decided taking into account the effect of design (intraclass correlation
      coefficient of 0.01).The power was 80% and alpha risk 5%.
    

Intervention name(s): EIRA intervention
Intervention type(s): Behavioral
Intervention description(s): Individual intervention has an average intensity between 2 and 3 visits; if necessary, professionals have the freedom to make a greater number of visits. Group intervention is carried out through health education workshops. These workshops take place 15-20 days after initiating the individual intervention and they are conducted by primary care providers in the health center. A group of 12-15 people attend in each workshop. Community intervention focuses mainly on the social prescription of resources and activities that are carried out in the community where the participant person resides. In addition the intervention has the support of information and communication technologies, such as a web addressed to the participant, a mobile app or the sending personalized text messages.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster randomized controlled trial
Masking: None (Open Label)
Primary purpose: Health Services Research