Are we leaving someone behind? A critical discourse analysis on the understanding of public participation among people with experiences of participatory research.

Participatory research (PR) is on the rise. In Spain, PR is scarce in the field of health, although there is an increasing interest in the matter. A comprehensive understanding of the meanings and practical implications of "public participation" is essential to promote participation in health research. The aim of the study is to explore the discursive positions on PR among individuals with experience in participatory processes in different areas and how this understanding translates into practice. We conducted a critical discourse analysis of 21 individuals with experience in PR and participatory processes (13 women, 8 men), mainly from the field of health and other areas of knowledge. Sixteen were Spanish and the rest were from the United Kingdom (3), United States (1), and Canada (1). Interviews were conducted in person or by telephone. The fieldwork was conducted between March 2019 and November 2019. The dominant discourses on public participation are situated along two axes situated on a continuum: the purpose of public participation and how power should be distributed in public participation processes. The first is instrumental public participation, which sees participatory research as a tool to improve research results and focuses on institutional interests and power-decision making is hold by researchers and institutions. The second, is transformative public participation, with a focus on social change and an equitable sharing of decision-making power between the public and researchers. All discursive positions stated that they do not carry out specific strategies to include the most socially disadvantaged individuals or groups. A shift in the scientific approach about knowledge, along with time and resources, are required to move towards a more balanced power distribution in the processes involving the public.

Time for themselves: Perceptions of physical activity among first and second-generation Pakistani women living in the Raval, Barcelona.

OBJECTIVES: Pakistani women experience higher-than-average rates of certain chronic diseases, including diseases related to sedentary lifestyles. The aim of this study is to explore how first and second-generation Pakistani women living in the Raval, Barcelona, conceive of physical activity, and their barriers and facilitators around participating in physical activity, with the goal of increasing physical activity in this group. METHODS: Qualitative research with an intersectional approach. Nine informal interviews with key community informants were conducted from November 2018 to January 2019 to gain background on the topic, using snowball sampling. Eleven individual interviews were conducted from February to June 2019. Seven were with Pakistani women having lived, or currently living, in the neighborhood of the Raval, Barcelona. Four additional interviews were conducted with non-Pakistani women key community informants who have worked extensively with this community. Thematic content analysis was carried out using ATLAS.ti. RESULTS: First-generation Pakistani women generally did not have physical activity present in their daily lives, but by most accounts wished to. Areas that shed light on this included the following: limited economic opportunities and associated living conditions, barriers to social integration, health concepts and access to information, and cultural norms and related gender roles. For the first-generation, gender-related divisions of labor as well as the absence of the concept of self-care were particularly relevant barriers to their participation in physical activity. The experience of immigration-related grief emerged as a transversal theme which overlapped with multiple areas. While both generations expressed a need for the separation of genders during physical activity-as per their cultural interpretation of Islam-the lack of such spaces was highlighted as a principal barrier in physical activity among the second generation. CONCLUSION: These findings shed light on distinct elements that exert influence in Pakistani women immigrants' participation in physical activity-among them: social and living conditions, access to public space, and gender-related work distribution and cultural norms-which are in turn influenced by first or second-generation immigration status. Considering the specific needs of both groups when proposing politics and health programs to encourage physical activity is paramount in order to successfully partner with these populations.

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.

BACKGROUND: 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. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03136211 . Registered 2 May 2017, "retrospectively registered".

"Not Alone in Loneliness": A Qualitative Evaluation of a Program Promoting Social Capital among Lonely Older People in Primary Health Care.

The weekly group-based program "Paths: from loneliness to participation" was conducted face-to-face over 15 sessions by nurses, social workers and volunteers in primary care in Catalonia (Spain) to alleviate loneliness among older people by promoting peer support and participation in community assets. We aimed at exploring participants' experiences of loneliness and participation prior to the program and its perceived benefits. The qualitative design was descriptive-interpretative. Data were collected through three focus groups and 41 interviews applying a semistructured topic guide involving 26 older participants, six professionals and nine volunteers. Participant-observation of all sessions involved the 38 older people who started the program. A thematic content analysis was applied. Older persons with diverse profiles of loneliness and participation explained different degrees of decrease in loneliness, an increase in participation in local community assets, companionship, peer support and friendship, and an empowerment process. Successful cases reported improvements in mental wellbeing and recovering the sense that life was worth living. Loneliness persisted among some widowed participants and vulnerabilities hampered some benefits. Participants, professionals and volunteers reported different degrees of success in older people to alleviate loneliness by enhancing social relationships and activities through complex processes interrelated with health and socioeconomic factors.

[Bibliometric analysis of female authorship in original articles in the journal ATENCIÓN PRIMARIA]. / Análisis bibliométrico de la autoría femenina en artículos originales en la revista ATENCIÓN PRIMARIA.

OBJECTIVES: To determine the percentage of female authors in original articles published during 2periods, in the journal of Atención Primaria (Primary Care), and to examine the differences between the categories of authorship (first, last author, and co-author) between both periods. DESIGN: Cross-sectional study. SETTING: Feminine scientific production published during the periods 2007-2008 and 2017-2018. PARTICIPANTS: The study was focused on original articles. MAIN MEASUREMENTS: The following variables were collected in an ad hoc form: gender based on the name of the author, total number of women and men appearing as authors, and order of authorship. Absolute and relative authorship frequencies were calculated, and the χ2 test was used to examine the evolution of the percentages by type of authorship and gender. RESULTS: A total of 108 articles were analysed in 2007-2008, and 100 in 2017-2018. No statistically significant differences were observed between the mean numbers of women authors within and between periods. In 2007-2008 a total of 548 female authors were identified and 540 in 2017-2018, the percentage of female authors was 48.7% and 54.4%, respectively. Only an increase in the percentage of first authors was observed between periods. CONCLUSIONS: Practically one out of every 2authors of original articles published in the journal Atención Primaria was female. There was also a significant increase in the percentage of female first authors between the 2periods. Nevertheless, and despite the greater number of health workers, the number of latest female authors remain unchanged, which points to the persistence of female under-representation.

[How to measure the migration status of the child and young population? Studies on health and inequalities in health in Europe]. / ¿Cómo medir el estatus migratorio de la población infantil y juvenil? Estudios sobre salud y desigualdades en salud en Europa.

OBJECTIVE: To analyse how the migration status of the child and young population is measured in the scientific literature on health and social inequalities in health in Europe. METHOD: A systematic search of the literature published in Spanish, English and French between 2007 and 2017 in PubMed and Social Sciences Citation Index was carried out. The included studies analysed health and social inequalities in health of a population under 18 years old according to its migration origin in Europe. The variables used to measure the migration status were described. RESULTS: 50 articles were included. Twenty studies analysed perinatal health, eleven mental health, nine dental health, and ten studies other variables. The main variables to define migration status were the country of birth (32 studies), either of the child, the mother, or one of the parents, and sometimes in a complementary way. Less frequent was the use of nationality (15 studies), of the child, or of the parents, especially the mother. Migration status is referred to in very different ways, not always comparable and sometimes the variable used is not clearly explained. CONCLUSIONS: There is a great diversity of ways to measure migration status in the child and young population. A better definition and consensus is needed to improve the temporal and geographical comparability of knowledge in this area, which will help to design public policies aimed at reducing social inequalities in health from childhood.

Medication-related problems in older people in Catalonia: A real-world data study.

PURPOSE: The aim of this study was to determine medication-related problems (MRPs) in primary care patients over 65 years of age. METHODS: Cross-sectional study based on the electronic health records of patients (65-99 years of age) visited in 284 primary health care centers during 2012 in Catalonia. VARIABLES: age, sex, sociodemographic variables, number of drugs, kidney and liver function and MRPs (duplicate therapy, drug-drug interactions, potentially inappropriate medications [PIMs] and drugs contraindicated in chronic kidney disease and in liver diseases). Unconditional logistic regression models were used to identify the factors associated with MRPs in patients with multimorbidity. RESULTS: 916 619 older people were included and 853 085 of them met the criteria for multimorbidity. Median age was 75 years and 57.7% of them were women. High percentages of MRPs were observed: PIMs (62.8%), contraindicated drugs in chronic kidney disease (12.1%), duplicate therapy (11.1%), contraindicated drugs in liver diseases (4.2%), and drug-drug interactions (1.0%). These numbers were higher in the subgroup of patients with ≥10 diseases. The most common PIMs were connected to drugs that increase the risk of fall (66.8%), antiulcer agents without criteria for gastroprotection (40.6%), and the combination of drugs with anticholinergic effects (39.7%). In the multivariate analysis, the variables associated with all MRPs among the patients with multimorbidity were the number of drugs and the number of visits. CONCLUSIONS: The coexistence of multimorbidity and polypharmacy is associated with an elevated risk of MRPs in older people. Medication safety for older patients constitutes a pressing concern for health services.

Multimorbidity patterns, polypharmacy and their association with liver and kidney abnormalities in people over 65 years of age: a longitudinal study.

BACKGROUND: The implementation of individual clinical practice guidelines in patients with multimorbidity often results in polypharmacy. Our aim was to analyse medication use according to longitudinal multimorbidity patterns (MP) and determine during a 5-year period (2012-16) which MP are associated with abnormal liver and kidney function in primary care patients over 65 years of age living in Catalonia. METHODS: Design: Longitudinal study (years 2012 to 2016) based on the electronic health records contained in Information System for Research in Primary Care database of the Catalan Institute of Health (SIDIAP). VARIABLES: age, sex, MP, medication and polypharmacy (drug exposure obtained from the Pharmacy Invoice Registry). Medicines were classified in accordance with the Anatomical Therapeutic Chemical Classification System (ATC). Glomerular filtration rate was used to determine abnormal kidney function, and serum levels of alkaline phosphatase, alanine transaminase and gamma-glutamyl transpeptidase were used to diagnose abnormal liver function. STATISTICS: For medication use in MP, we calculated annual mean packages of each drug in each MP, and observed/expected ratios were obtained by dividing mean packages in the cluster by mean packages of the same drug in the overall population. Logistic regression models were fitted to estimate the association between MP at baseline and abnormal kidney and liver function tests during follow up. RESULTS: Nine hundred sixteen thousand six hundred nineteen patients were included, and 743,827 completed the follow up. We identified one polypharmacy profile per MP, and concluded that the most prescribed drugs in each pattern corresponded to the diseases overrepresented in that specific MP. The median of drugs ranged from 3 (Cluster 1 - Non-Specific) to 8 (Cluster 10 - Multisystem Pattern). Abnormal kidney function was most commonly observed in the Cluster 4 - Cardio-Circulatory and Renal (Odds Ratio [OR] 2.19; Confidence interval [CI] 95% 2.15-2.23) and Cluster 3 - Minority Metabolic Autoimmune-Inflammatory (OR 2.16; CI 95% 2.12-2.20) MP. A higher risk of abnormal liver function was observed in the Cluster 8 - Digestive (OR 3.39; CI 95% 3.30-3.49), and Cluster 4 - Cardio-Circulatory and Renal (OR 1.96; CI 95% 1.91-2.02) MP. CONCLUSIONS: A higher risk of abnormal kidney and liver function was observed in specific MP. The long-term characterisation of MP and polypharmacy illustrates the burden of chronic multimorbidity and polypharmacy in the elderly population.

Qualitative evaluation of a community-based intervention to reduce social isolation among older people in disadvantaged urban areas of Barcelona.

This study analyses participants' and coordinators' perceptions of the implementation process and perceived benefits of a community-based intervention to reduce social isolation among older adults. The 'School of Health for Older People' is a weekly community intervention that promotes resources among individuals and communities in order to enhance their ability to identify problems and activate solutions, encouraging participation in the community. A qualitative approach was employed, based on semi-structured interviews and focus groups (FGs). This study was carried out in Barcelona. Two coordinators (community nurses) and 26 community-dwelling people aged 65 and over who attended the School of Health for Older People in the neighbourhoods of Besòs and Guineueta, participated in in-depth interviews and FGs between January and February 2016. Views and experiences about the intervention were explored. The main perceived effects of the intervention were expanding knowledge of health issues and of community activities, encouraging participants to go out, giving them a feeling of being heard, and peer relationships, increasing participants' contacts and knowledge while the main negative features were related to repetition of certain contents. The benefits identified included learning something about health and their own neighbourhood and breaking the habit of staying at home. Social isolation might be prevented by increasing the number of contacts with peers and sharing a common interest, since it could help to give them a sense of belonging to a community.

[Public participation in research projects: ways of creating collective knowledge in health]. / Participación pública en los proyectos de investigación: formas de crear conocimiento colectivo en salud.

Public participation in research projects is an emerging area in Spain and Latin American countries. There are five types of projects according to the degree of involvement that the participants have in the processes: contributory, collaborative, co-created, contractual and independent. In order to promote public participation in health research teams, their practices and competencies need to be redefined. To this end, it may be useful to ask questions in the different phases of the research, as well as to develop strategies that include audiences that have fewer channels of participation in favour of favouring equity in health. This way of doing science allows gathering experience and expertise prioritizing and adapting the research to the needs of the population, which increases its transforming capacity and the social impact of its results.

Medication patterns in older adults with multimorbidity: a cluster analysis of primary care patients.

BACKGROUND: Older adults suffer from various chronic conditions which make them particularly vulnerable. The proper management of multiple drug use is therefore crucial. The aim of our study was to describe drug prescription and medication patterns in this population. METHODS: A cross-sectional study in Barcelona (Spain) using electronic health records from 50 primary healthcare centres. Participants were aged 65 to 94 years, presenting multimorbidity (≥2 chronic diseases), and had been prescribed at least 1 drug for 6 months or longer during 2009. We calculated the prevalence of prescribed drugs and identified medication patterns using multiple correspondence analysis and k-means clustering. Analyses were stratified by sex and age (65-79, 80-94 years). RESULTS: We studied 164,513 patients (66.8% women) prescribed a median of 4 drugs (interquartile range [IQR] = 3-7) in the 65-79 age-group and 6 drugs (IQR = 4-8) in the 80-94 age-group. A minimum of 45.9% of patients aged 65-79 years, and 61.8% of those aged 80-94 years, were prescribed 5 or more drugs. We identified 6 medication patterns, a non-specific one and 5 encompassing 8 anatomical groups (alimentary tract and metabolism, blood, cardiovascular, dermatological, musculo-skeletal, neurological, respiratory, and sensory organ). CONCLUSIONS: Drug prescription is widespread among the elderly. Six medication patterns were identified, 5 of which were related to one or more anatomical group, with associations among drugs from different systems. Overall, guidelines do not accurately reflect the situation of the elderly multimorbid, new strategies for managing multiple drug uses are needed to optimize prescribing in these patients.

Effect of the comprehensive smoke-free law on time trends in smoking behaviour in primary healthcare patients in Spain: a longitudinal observational study.

OBJECTIVE: This study aimed to analyse the impact of comprehensive smoke-free legislation (SFL) on the prevalence and incidence of adult smoking in primary healthcare (PHC) patients from three Spanish regions, overall and stratified by sex. DESIGN: Longitudinal observational study conducted between 2008 and 2013. SETTING: 66 PHC teams in Catalonia, Navarre and the Balearic Islands (Spain). PARTICIPANTS: Population over 15 years of age assigned to PHC teams. PRIMARY AND SECONDARY OUTCOMES MEASURES: Quarterly age-standardised prevalence of non-smoker, smoker and ex-smoker and incidence of new smoker, new ex-smoker and ex-smoker relapse rates were estimated with data retrieved from PHC electronic health records. Joinpoint analysis was used to analyse the trends of age-standardised prevalence and incidence rates. Trends were expressed as annual percentage change and average annual percent change. RESULTS: The overall standardised smoker prevalence rate showed a significant downward trend (higher in men than women) and the overall standardised ex-smoker prevalence rate showed a significant increased trend (higher in women than men) in the three regions. Standardised smoker and ex-smoker prevalence rates were higher for men than women in all regions. With regard to overall trends of incidence rates, new smokers decreased significantly in Catalonia and Navarre and similarly in men and women, new ex-smokers decreased significantly and more in men in Catalonia and the Balearic Islands, and ex-smoker relapse increased in Catalonia (particularly in women) and decreased in Navarre. CONCLUSIONS: Trends in smoking behaviour in PHC patients remain unchanged after the implementation of comprehensive SFL. The impact of the comprehensive SFL might have been lessened by the effect of the preceding partial SFL.

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.

[Public participation in research from the perspective of primary health care researchers]. / La participación ciudadana en la investigación desde la perspectiva de investigadores de atención primaria.

OBJECTIVE: Explore the strengths, weaknesses, opportunities and threats (SWOT) for development of public involvement in research by Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAPJGol) according to primary health care researchers in Catalonia (Spain). METHODS: Cross-sectional study carried out in 2017 with 36 primary health care research teams accredited by IDIAPJGol and its management staff. An open questionnaire (paper and online) was designed and piloted to develop a SWOT technique, and 65 answers were obtained (14 in paper and 51 online). A thematic content analysis was carried out. RESULTS: Most informants consider public involvement in research a useful, innovative, viable and essential strategy, but it requires a change of mentality and a move away from the hierarchical paradigm. It can be difficult to execute and can complicate studies. They are concerned about which citizens should be involve, how to select them, possible conflicts of interest and training needs. The main proposals for its implementation are to disseminate previous strategies, encourage motivation and synergies among citizens, researchers and institutions, and to clarify the roles of the actors involved. IDIAPJGol should develop recommendations for the public involvement in research, encourage their inclusion, have a mentor and advise the research teams. CONCLUSIONS: Despite the challenges, developing public involvement in research in primary health care is essential and feasible, what it is more should be based on a participatory strategy with all actors. The citizens can participate in any kind of design and phase of the research, adapting each project, being the primary health care a privileged area to develop the public involvement in research.

Coping Strategies and Social Support in a Mobile Phone Chat App Designed to Support Smoking Cessation: Qualitative Analysis.

BACKGROUND: Smoking is one of the most significant factors contributing to low life expectancy, health inequalities, and illness at the worldwide scale. Smoking cessation attempts benefit from social support. Mobile phones have changed the way we communicate through the use of freely available message-oriented apps. Mobile app-based interventions for smoking cessation programs can provide interactive, supportive, and individually tailored interventions. OBJECTIVE: This study aimed to identify emotions, coping strategies, beliefs, values, and cognitive evaluations of smokers who are in the process of quitting, and to analyze online social support provided through the analysis of messages posted to a chat function integrated into a mobile app. METHODS: In this descriptive qualitative study, informants were smokers who participated in the chat of Tobbstop. The technique to generate information was documentary through messages collected from September 2014 through June 2016, specifically designed to support a smoking cessation intervention. A thematic content analysis of the messages applied 2 conceptual models: the Lazarus and Folkman model to assess participant's experiences and perceptions and the Cutrona model to evaluate online social support. RESULTS: During the study period, 11,788 text messages were posted to the chat by 101 users. The most frequent messages offered information and emotional support, and all the basic emotions were reported in the chat. The 3 most frequent coping strategies identified were physical activity, different types of treatment such as nicotine replacement, and humor. Beliefs about quitting smoking included the inevitability of weight gain and the notion that not using any type of medications is better for smoking cessation. Health and family were the values more frequently described, followed by freedom. A smoke-free environment was perceived as important to successful smoking cessation. The social support group that was developed with the app offered mainly emotional and informational support. CONCLUSIONS: Our analysis suggests that a chat integrated into a mobile app focused on supporting smoking cessation provides a useful tool for smokers who are in the process of quitting, by offering social support and a space to share concerns, information, or strategies.

Correction to: 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.

It has been highlighted the original article (1) contained a typesetting mistake in the authorship, and that author Caterine Vicens was omitted.

Multimorbidity patterns with K-means nonhierarchical cluster analysis.

BACKGROUND: The purpose of this study was to ascertain multimorbidity patterns using a non-hierarchical cluster analysis in adult primary patients with multimorbidity attended in primary care centers in Catalonia. METHODS: Cross-sectional study using electronic health records from 523,656 patients, aged 45-64 years in 274 primary health care teams in 2010 in Catalonia, Spain. Data were provided by the Information System for the Development of Research in Primary Care (SIDIAP), a population database. Diagnoses were extracted using 241 blocks of diseases (International Classification of Diseases, version 10). Multimorbidity patterns were identified using two steps: 1) multiple correspondence analysis and 2) k-means clustering. Analysis was stratified by sex. RESULTS: The 408,994 patients who met multimorbidity criteria were included in the analysis (mean age, 54.2 years [Standard deviation, SD: 5.8], 53.3% women). Six multimorbidity patterns were obtained for each sex; the three most prevalent included 68% of the women and 66% of the men, respectively. The top cluster included coincident diseases in both men and women: Metabolic disorders, Hypertensive diseases, Mental and behavioural disorders due to psychoactive substance use, Other dorsopathies, and Other soft tissue disorders. CONCLUSION: Non-hierarchical cluster analysis identified multimorbidity patterns consistent with clinical practice, identifying phenotypic subgroups of patients.

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.

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 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. 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 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. 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. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03136211 .Retrospectively registered on May 2, 2017.