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

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

Qualitative evaluation of a complex intervention to implement health promotion activities according to healthcare attendees and health professionals: EIRA study (phase II)

Objective: To evaluate the implementation and development of a complex intervention on health promotion and changes in health-promoting behaviours in primary healthcare according to healthcare attendees and health professionals. Design: Descriptive qualitative evaluation research conducted with 94 informants. Data collection techniques consisted of 14 semistructured individual interviews, 9 discussion groups, 1 triangular group and 6 documents. Three analysts carried out a thematic content analysis with the support of Atlas.ti software. This evaluation was modelled on Proctor and colleagues’ concept of outcomes for implementation research. Setting: 7 primary care centres from seven Spanish regions: Andalusia, Aragon, Balearic Islands, Basque Country, Castilla-La Mancha, Castilla-Leon and Catalonia. Participants: The study population were healthcare attendees (theoretical sampling) and health professionals (opportunistic sampling) who had participated in the exploratory trial of the EIRA intervention (2015). Results: Healthcare attendees and professionals had a positive perception of the study. Healthcare attendees even reported that they would recommend participation to family and friends. Health professionals became aware of the significance of the motivational interview, especially for health promotion, and emphasised social prescribing of physical activity. They also put forward recommendations to improve recruitment, screening and retention of participants. Healthcare attendees modified behaviours and health professionals modified working practices. To achieve sustainability, health professionals believe that it is crucial to adapt agendas and involve all the staff. Conclusions: The discourses of all stakeholders on the intervention must be taken into consideration for the successful, setting-specific implementation of adequate, acceptable, equitable and sustainable strategies aimed at health promotion and well-being

Multiple health behaviour change primary care intervention for smoking cessation, physical activity and healthy diet in adults 45 to 75 years old (EIRA study): a hybrid effectiveness-implementation cluster randomised trial

Health behaviour; Health promotion; Hybrid trialComportamiento de salud; Promoción de la salud; Prueba híbridaComportament de salut; promoció de la salut; Prova híbridaBackground This study aimed to evaluate the effectiveness of a) a Multiple Health Behaviour Change (MHBC) intervention on reducing smoking, increasing physical activity and adherence to a Mediterranean dietary pattern in people aged 45–75 years compared to usual care; and b) an implementation strategy. Methods A cluster randomised effectiveness-implementation hybrid trial-type 2 with two parallel groups was conducted in 25 Spanish Primary Health Care (PHC) centres (3062 participants): 12 centres (1481 participants) were randomised to the intervention and 13 (1581 participants) to the control group (usual care). The intervention was based on the Transtheoretical Model and focused on all target behaviours using individual, group and community approaches. PHC professionals made it during routine care. The implementation strategy was based on the Consolidated Framework for Implementation Research (CFIR). Data were analysed using generalised linear mixed models, accounting for clustering. A mixed-methods data analysis was used to evaluate implementation outcomes (adoption, acceptability, appropriateness, feasibility and fidelity) and determinants of implementation success. Results 14.5% of participants in the intervention group and 8.9% in the usual care group showed a positive change in two or all the target behaviours. Intervention was more effective in promoting dietary behaviour change (31.9% vs 21.4%). The overall adoption rate by professionals was 48.7%. Early and final appropriateness were perceived by professionals as moderate. Early acceptability was high, whereas final acceptability was only moderate. Initial and final acceptability as perceived by the participants was high, and appropriateness moderate. Consent and recruitment rates were 82.0% and 65.5%, respectively, intervention uptake was 89.5% and completion rate 74.7%. The global value of the percentage of approaches with fidelity ≥50% was 16.7%. Eight CFIR constructs distinguished between high and low implementation, five corresponding to the Inner Setting domain. Conclusions Compared to usual care, the EIRA intervention was more effective in promoting MHBC and dietary behaviour change. Implementation outcomes were satisfactory except for the fidelity to the planned intervention, which was low. The organisational and structural contexts of the centres proved to be significant determinants of implementation effectiveness

Effectiveness of a Multicomponent Intervention in Primary Care That Addresses Patients with Diabetes Mellitus with Two or More Unhealthy Habits, Such as Diet, Physical Activity or Smoking: Multicenter Randomized Cluster Trial (EIRA Study)

Introduction: We evaluated the effectiveness of an individual, group and community intervention to improve the glycemic control of patients with diabetes mellitus aged 45–75 years with two or three unhealthy life habits. As secondary endpoints, we evaluated the inverventions’ effectiveness on adhering to Mediterranean diet, physical activity, sedentary lifestyle, smoking and quality of life. Method: A randomized clinical cluster (health centers) trial with two parallel groups in Spain from January 2016 to December 2019 was used. Patients with diabetes mellitus aged 45–75 years with two unhealthy life habits or more (smoking, not adhering to Mediterranean diet or little physical activity) participated. Centers were randomly assigned. The sample size was estimated to be 420 people for the main outcome variable. Educational intervention was done to improve adherence to Mediterranean diet, physical activity and smoking cessation by individual, group and community interventions for 12 months. Controls received the usual health care. The outcome variables were: HbA1c (main), the Mediterranean diet adherence score (MEDAS), the international diet quality index (DQI-I), the international physical activity questionnaire (IPAQ), sedentary lifestyle, smoking ≥1 cigarette/day and the EuroQuol questionnaire (EVA-EuroQol5D5L). Results: In total, 13 control centers (n = 356) and 12 intervention centers (n = 338) were included with similar baseline conditions. An analysis for intention-to-treat was done by applying multilevel mixed models fitted by basal values and the health center: the HbA1c adjusted mean difference = −0.09 (95% CI: −0.29–0.10), the DQI-I adjusted mean difference = 0.25 (95% CI: −0.32–0.82), the MEDAS adjusted mean difference = 0.45 (95% CI: 0.01–0.89), moderate/high physical activity OR = 1.09 (95% CI: 0.64–1.86), not living a sedentary lifestyle OR = 0.97 (95% CI: 0.55–1.73), no smoking OR = 0.61 (95% CI: 0.54–1.06), EVA adjusted mean difference = −1.26 (95% CI: −4.98–2.45). Conclusions: No statistically significant changes were found for either glycemic control or physical activity, sedentary lifestyle, smoking and quality of life. The multicomponent individual, group and community interventions only showed a statistically significant improvement in adhering to Mediterranean diet. Such innovative interventions need further research to demonstrate their effectiveness in patients with poor glycemic control

Health-care users, key community informants and primary health care workers' views on health, health promotion, health assets and deficits : qualitative study in seven Spanish regions

Although some articles have analysed the definitions of health and health promotion from the perspective of health-care users and health care professionals, no published studies include the simultaneous participation of health-care users, primary health care professionals and key community informants. Understanding the perception of health and health promotion amongst these different stakeholders is crucial for the design and implementation of successful, equitable and sustainable measures that improve the health and wellbeing of populations. Furthermore, the identification of different health assets and deficits by the different informants will generate new evidence to promote healthy behaviours, improve community health and wellbeing and reduce preventable inequalities. The objective of this study is to explore the concept of health and health promotion and to compare health assets and deficits as identified by health-care users, key community informants and primary health care workers with the ultimate purpose to collect the necessary data for the design and implementation of a successful health promotion intervention. A descriptive-interpretive qualitative research was conducted with 276 participants from 14 primary care centres of 7 Spanish regions. Theoretical sampling was used for selection. We organized 11 discussion groups and 2 triangular groups with health-care users; 30 semi-structured interviews with key community informants; and 14 discussion groups with primary health care workers. A thematic content analysis was carried out. Health-care users and key community informants agree that health is a complex, broad, multifactorial concept that encompasses several interrelated dimensions (physical, psychological-emotional, social, occupational, intellectual, spiritual and environmental). The three participants' profiles consider health promotion indispensable despite defining it as complex and vague. In fact, most health-care users admit to having implemented some change to promote their health. The most powerful motivators to change lifestyles are having a disease, fear of becoming ill and taking care of oneself to maintain health. Health-care users believe that the main difficulties are associated with the physical, social, working and family environment, as well as lack of determination and motivation. They also highlight the need for more information. In relation to the assets and deficits of the neighbourhood, each group identifies those closer to their role. Generally, participants showed a holistic and positive concept of health and a more traditional, individual approach to health promotion. We consider therefore crucial to depart from the model of health services that focuses on the individual and the disease toward a socio-ecological health model that substantially increases the participation of health-care users and emphasizes health promotion, wellbeing and community participation

Effectiveness of a multiple health-behaviour-change intervention in increasing adherence to the Mediterranean Diet in adults (EIRA study): a randomized controlled hybrid trial

Background: The present study describes the efectiveness of a complex intervention that addresses multiple lifestyles to promote healthy behaviours in increasing adherence to the Mediterranean diet (MD). Methods: Cluster-randomised, hybrid clinical trial controlled with two parallel groups. The study was carried out in 26 primary Spanish healthcare centres. People aged 45–75 years who presented at least two of the following crite‑ ria were included: smoker, low adherence to the MD or insufcient level of physical activity. The intervention group (IG) had three diferent levels of action: individual, group, and community, with the aim of acting on the behaviours related to smoking, diet and physical activity at the same time. The individual intervention included personalised recommendations and agreements on the objectives to attain. Group sessions were adapted to the context of each healthcare centre. The community intervention was focused on the social prescription of resources and activities performed in the environment of the community of each healthcare centre. Control group (CG) received brief advice given in the usual visits to the doctor’s ofce. The primary outcome was the change, after 12 months, in the number of participants in each group with good adherence to the MD pattern. Secondary outcomes included the change in the total score of the MD adherence score (MEDAS) and the change in some cardiovascular risk factors. Results: Three thousand sixty-two participants were included (IG=1,481, CG=1,581). Low adherence to the MD was present in 1,384 (93.5%) participants, of whom 1,233 initiated the intervention and conducted at least one individual visit with a healthcare professional. A greater increase (13.7%; 95% CI, 9.9–17.5; p<0.001) was obtained by IG in the number of participants who reached 9 points or more (good adherence) in the MEDAS at the fnal visit. Moreover, the efect attributable to the intervention obtained a greater increase (0.50 points; 95% CI, 0.35 to 0.66; p<0.001) in IG. Conclusions: A complex intervention modelled and carried out by primary healthcare professionals, within a real clinical healthcare context, achieved a global increase in the adherence to the MD compared to the brief advice

Beyond the consultation room : Proposals to approach health promotion in primary care according to health-care users, key community informants and primary care centre workers

Primary health care () is the ideal setting to provide integrated services centred on the person and to implement health promotion () activities. To identify proposals to approach in the context of primary care according to health-care users aged 45-75 years, key community informants and primary care centre () workers. Descriptive-interpretive qualitative research with 276 participants from 14 of seven Spanish regions. A theoretical sampling was used for selection. A total of 25 discussion groups, two triangular groups and 30 semi-structured interviews were carried out. A thematic interpretive contents analysis was carried out. Participants consider that is not solely a matter for the health sector and they emphasize intersectoral collaboration. They believe that it is important to strengthen community initiatives and to create a healthy social environment that encourages greater responsibility and participation of health-care users in decisions regarding their own health and better management of public services and resources. , care in the community and demedicalization should be priorities for . Participants propose organizational changes in the to improve . workers are aware that falls within the scope of their responsibilities and propose to increase their training, motivation, competences and knowledge of the social environment. Informants emphasize that should be person-centred approach and empathic communication. activities should be appealing, ludic and of proven effectiveness. According to a socio-ecological and intersectoral model, services must get actively involved in together with community and through outreach interventions

Complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in primary health care (EIRA study): study protocol for a hybrid trial

CDATA[CDATA[Background: Health 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 01 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. CDATA[CDATA[Methods: This 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 Spam 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 gamed measured by the tanffs of the EuioQo! 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. CDATA[CDATA[Discussion: EIRA 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

Multiple health behaviour change primary care intervention for smoking cessation, physical activity and healthy diet in adults 45 to 75 years old (EIRA study): a hybrid effectiveness-implementation cluster randomised trial

Methods: A cluster randomised effectiveness-implementation hybrid trial-type 2 with two parallel groups was conducted in 25 Spanish Primary Health Care (PHC) centres (3062 participants): 12 centres (1481 participants) were randomised to the intervention and 13 (1581 participants) to the control group (usual care). The intervention was based on the Transtheoretical Model and focused on all target behaviours using individual, group and community approaches. PHC professionals made it during routine care. The implementation strategy was based on the Consolidated Framework for Implementation Research (CFIR). Data were analysed using generalised linear mixed models, accounting for clustering. A mixed-methods data analysis was used to evaluate implementation outcomes (adoption, acceptability, appropriateness, feasibility and fidelity) and determinants of implementation success. Results: 14.5% of participants in the intervention group and 8.9% in the usual care group showed a positive change in two or all the target behaviours. Intervention was more effective in promoting dietary behaviour change (31.9% vs 21.4%). The overall adoption rate by professionals was 48.7%. Early and final appropriateness were perceived by professionals as moderate. Early acceptability was high, whereas final acceptability was only moderate. Initial and final acceptability as perceived by the participants was high, and appropriateness moderate. Consent and recruitment rates were 82.0% and 65.5%, respectively, intervention uptake was 89.5% and completion rate 74.7%. The global value of the percentage of approaches with fidelity ≥50% was 16.7%. Eight CFIR constructs distinguished between high and low implementation, five corresponding to the Inner Setting domain. Conclusions: Compared to usual care, the EIRA intervention was more effective in promoting MHBC and dietary behaviour change. Implementation outcomes were satisfactory except for the fidelity to the planned intervention, which was low. The organisational and structural contexts of the centres proved to be significant determinants of implementation effectiveness