An interventional study of EIRA intervention in Health Behavior, Health Promotion and Primary Health Care, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Completed at 1 site in Spain. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-07.
Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Health services research
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.
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 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%.
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 158 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
EIRA intervention It is based on the Transtheoretical Model (TTM) and States of Change and it is made by physicians and nurses in routine care of primary care practices according to the conceptual framework of the "5A": Ask, Advise, Assess, Assist, and Arrange. It consists of a first visit of screening ("Ask"). Subsequently, the professional develops a personalized plan that is negotiated with the participant ("Advise" and "Assess"). This plan is reviewed during successive visits and positive changes are reinforced and new objectives are negotiated ("Assist" and "Arrange"). The motivational interview is the essential tool of the intervention. The intervention is carried out to different levels: individual, group and community.
Behavioral: EIRA intervention
Health providers of this group integrate in their practice the recommendations of the Program of Preventive Activities and Health Promotion (PAPPS)". These guidelines are based on systematic screening and brief advice for the prevention of cardiovascular and mental diseases and cancer as well as vaccine recommendations.
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.
Effectiveness: Positive change in baseline eating behavior
Adherence to the Mediterranean dietary pattern in low adherence people. For the evaluation, the 14-item Questionnaire of Mediterranean diet adherence (PREDIMED study) will be used.
Time frame: at the study entry and at 12 months
Effectiveness: Positive change in baseline physical activity behavior
Sufficient physical activity in insufficiently active people. For the evaluation, the "International Physical Questionnaire (IPAQ)" will be used.
Time frame: at the study entry and at 12 months
Effectiveness: Positive change in baseline smoking behavior
Smoking cessation in smokers. For the evaluation, the interview will be used and the cooximetry (optional).
Time frame: at the study entry and at 12 months
Implementation: adoption
Proportion of professionals who express their willingness to participate in the study between of total of potential professionals.
Time frame: Within 2 months prior to the start of the intervention
Implementation: early acceptability
They will be evaluated in professionals and participants by means of a survey.
Time frame: Within 2 months prior to the start of the intervention
Implementation: final acceptability
They will be evaluated in professionals and participants by means of a survey. What is more, discussion groups will be held at the end of the intervention with the professionals and participants.
Time frame: at 12 months post intervention
Implementation: early appropriateness
They will be evaluated in professionals and participants by means of a survey.
Time frame: Within 2 months prior to the start of the intervention
Implementation: final appropriateness
They will be evaluated in professionals and participants by means of a survey. What is more, discussion groups will be held at the end of the intervention with the professionals and participants.
Time frame: at 12 months post intervention
Implementation: Cost of time invested in training and organizational meetings
Cost of time invested in training and organizational meetings to carry out the intervention.
Time frame: at 12 months post intervention
Implementation: feasibility
On the basis of the calculation of participation, recruitment and retention rate.
Time frame: at 12 months post intervention
Implementation: fidelity of the motivational interview technique
The quality of the motivational interview will be evaluated through videotapes of visits to simulated patients through the "motivational interviewing assessment scale".
Time frame: Within 2 months prior to the start of the intervention
Implementation: fidelity of the planned intervention
The degree of compliance of the activities recorded in the case report form will be analyzed.
Time frame: at 12 months post intervention
Implementation: penetration
The proportion of professionals who have integrated the intervention into their usual clinical practice within six months of the end of intervention.
Time frame: Within six months of the end of intervention
Effectiveness: Beginning or making of a behavior change
Proportion of people who are in the stages of action, maintenance or termination according to the transtheoretical model at the entry and at the end of the study.
Time frame: at the study entry and at 12 months
Effectiveness: Change from baseline on arterial stiffness at 12 months
Arterial stiffness assessed by the "Cardio-Ankle Vascular Index (CAVI)". CAVI will be measured in the routine clinical practice by the Vascular Screening System VaSera VS-1500N.
Time frame: at the study entry and at 12 months.
Change from baseline on health-related quality of life
Health-related quality of life as measured by the EuroQol-5D questionnaire.
Time frame: at the study entry and at 12 months.
Change from baseline on costs of number visits, diagnostic tests, community resources used and loss of productivity
Number in the last 12 monts of: primary-care and specialists visits, outpatient diagnostic tests, community resources used, group sessions attended and days off work per participant
Time frame: at the study entry and at 12 months.
Effectiveness: Reduction of the cardiovascular risk
Proportion of people with low/moderate and high/very high baseline cardiovascular risk who have reduced it by 10% and 25% respectively. Cardiovascular risk will be calculated using REGICOR and SCORE function charts.
Time frame: at the study entry and at 12 months
Effectiveness: Reduction of the risk of depression
Effect size greater than or equal to 8% in the probability of risk of depression in people with moderate to high risk of depression at the entry of study. People have received usual care will be compared to those who received the EIRA intervention. Risk of depression will be calculated using the algorithm PredictD.
Time frame: at the study entry and at 12 months
Effectiveness:change from baseline on body mass index
Body mass index is defined as the body weight divided by the square of the body height, and is expressed in units of kg/m2.
Time frame: at the study entry and at 12 months.
Effectiveness:change from baseline on waist circumference
The waist circumference will be measured at a level midway between the lowest rib and the iliac crest. It will be expressed in units of cm.
Time frame: at the study entry and at 12 months.
Effectiveness:change from baseline on blood pressure
It will be measured in the routine clinical practice by validated electronic monitors and it will be expressed in units of mmHg.
Time frame: at the study entry and at 12 months.
Effectiveness:change from baseline on lipid profile
The lipid profile will include: low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides and total cholesterol. They will be expressed in units of mg/dl.
Time frame: at the study entry and at 12 months.
Effectiveness: change from baseline on ankle-brachial index
It will be measured in the routine clinical practice by the Vascular Screening System VaSera VS-1500N.
Time frame: at the study entry and at 12 months.
Effectiveness: change from baseline on the "REgicor and Artper Score fOr aNkle brachial index (REASON)"
REASON is a validated screening test to select candidates for ankle-brachial index (ABI) measurement in the Spanish population. It uses clinical data routinely collected in general practice for cardiovascular risk estimation. This test integrates the following measures: personal history of hypercholesterolemia, diabetes mellitus, arterial hypertension, smoking, body mass index, blood pressure, glycaemia, total cholesterol, high density lipoprotein cholesterol (HDL-c), low density lipoprotein cholesterol (LDL-c), triglyceride, coronary heart disease risk using the Framingham function adapted to Spain and validated in this population and ABI measurement.
Time frame: at the study entry and at 12 months.
Effectiveness: change from baseline on the perceived functional social support
The questionnaire Duke-UNC-11 will be used to determine the perceived functional social support.
Time frame: at the study entry and at 12 months.
Effectiveness: change from baseline on anxiety symptoms
The General Anxiety Disorder-7 (GAD-7) questionnaire will be used to determine the prevalence and the severity of anxiety symptoms.
Time frame: at the study entry and at 12 months.
Effectiveness: change from baseline on diet quality
Diet Quality Index-International (DQI-I) will be used to determine diet quality.
Time frame: at the study entry and at 12 months.
Plan to share: No
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