About this trial
Despite widespread recognition of social, economic, or environmental health determinants, health action remains heavily dominated by individual-level solutions (e.g., medication, patient counselling, vaccination). This study aims to stimulate changes in health system functioning by demonstrating how the cocreation of actions to address psychological well-being, cardiovascular health, and antimicrobial resistance from within the community can alleviate the burden on primary care services, reduce medicalisation and increase health equity.
The scientific approach uses mixed methods and incorporates theory from multiple disciplines. This study will appraise how the current system addresses psychological well-being, cardiovascular (CV) health, and rational use of antibiotics using a population survey, a survey of patients collecting their medication at community pharmacies, aggregate health service indicators on medication consumption and primary care consultations, and qualitative methods exploring stakeholders' perceptions.The investigators will undertake community-based participatory research to engage citizen scientists in the cocreation of community-led actions to promote psychological well-being, CV health, and prevent antimicrobial resistance. The design, implementation, and evaluation of the actions will apply an assets-based approach and apply theories and frameworks from implementation science in an iterative manner over 3 years. Finally, the impact of the cocreated actions will be analysed, considering effectiveness and broader contextual issues such as initiative adoption, implementation, and maintenance. The investigators will use a before-after comparison of survey indicators, an interrupted time-series analysis of health service data and qualitative analysis.
The goal is to demonstrate how the integration of community action with attention to the social determinants of health, can lead to a more rational approach to health care and ultimately improve health and health equity.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Group 1 (Antidepressants and Anxiolytics): N05B, N05C, N06A.
Group 2 (Cardiovascular disease risk factor medication): A10B (antidiabetics), C10A (cholesterol-lowering drugs), C07A, C09A, C03C, C08C (antihypertensives).
Group 3 (Antibiotics): J01
People aged 18 and over who are residents or have a job or family connection in the Municipal District 2 of Elche (Spain) who are interested in participating, wish to be actively involved in the co-creation, planning, and implementation of community initiatives, and are available to attend the conferences, meetings, and workshops.
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Cocreation process
Other interventionThe cocreation process will involve various advisory and participatory bodies to ensure the active involvement of the community and local institutions, also with the research team, ensuring that actions respond to collective needs of the community. Recruitment of these advisory and participatory bodies will be carried out through a participatory strategy involving the Basic Health Councils of the healthcare centers in the area, as well as other associations, religious institutions, and local leaders. Based on previous sociograms, strategic locations will be identified for organizing informational meetings in accessible places in the area, such as community centers. Dissemination will be carried out through social media, posters, and other inclusive means to ensure the participation of vulnerable groups. Participation in the cocreation process will be open, voluntary, and will depend on the interest of individuals and entities in the area.
Treatment groups
Trial outcomes
Primary outcomes
Health-related quality of life
Health-related quality of life will be measured using the VR-12 questionnaire, which was internationally validated (Selim et al., 2022). The VR-12 questionnaire contains 12 items that assess eight aspects of health-related quality of life: physical dimension, mental dimension, physical function, physical role, bodily pain, general health, vitality, emotional role, social function, and mental health. The instrument measures eight scales that are used to produce a summary score in two different dimensions: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
Medical drug consumption
Aggregated data of Primary Care for the studied Basic Health Zones (BHZ): * Defined Daily Dose (DDD) per 1,000 inhabitants per day of drugs in classes N05B, N05C, and N06A prescribed to people over 12 years of age by an SNS professional in each basic health zone (BHZ). * DDD of drugs of classes N05B, N05C, and N06A that have been prescribed to persons over 12 years in each BHZ and are subsequently dispensed in a community pharmacy. * DDD of drugs of classes A10B, C10A, C07A, C09A, C03C, C08C prescribed to persons over 15 years in each BHZ. * DDD of drugs of classes A10B, C10A, C07A, C09A, C03C, C08C that have been prescribed to people over 15 years in each BHZ and are subsequently dispensed in a community pharmacy. * DDD of drugs of classes J01 prescribed to people over 15 years in each BHZ. * DDD of drugs of classes J01 that have been prescribed in each BHZ and are subsequently dispensed in a community pharmacy.
Workload in primary healthcare
The number of consultations carried out in each studied Basic Health Zone will be retrieved for people over 15 years, disaggregated by the reason for consultation. This indicator will be calculated monthly during the five years of the study and disaggregated by relevant sociodemographic characteristics. Similarly, the average number of medications per clinical encounter will be calculated by dividing the total number of prescriptions in each period by the total number of consultations. Similarly, at six-month intervals, the percentage of clinical encounters that result in the prescription of antibiotics will be computed.
Secondary outcomes
Critical Health literacy
Different domains of health literacy include basic functional health literacy (the ability to access, understand, evaluate, and apply health information), communicative health literacy, and critical health literacy (Nutbeam, 2020). This study is particularly concerned with critical health literacy because it involves the critical evaluation of information, understanding the social determinants of health, and is linked to collective action (Chinn, 2011). Furthermore, it is widely assumed that better critical health literacy leads to more effective and efficient use of services (Sykes et al., 2013). These aspects will be measured using the All Aspects of Health Literacy Scale (Chinn \& McCarthy, 2013) after analyzing the psychometric properties of a new version adapted to Spain scoring between 1 (lowest health literacy) and 43 (highest health literacy).
Social capital and community belonging
A measure related to social capital will be included, given that it is a key determinant of physical and mental health (Kawachi et al., 1999; Stoyanova \& Díaz-Serrano, 2009; Villalonga-Olives \& Kawachi, 2015). This study will develop a questionnaire based on a scale previously validated in the United States for Latino population (Villalonga-Olives et al., 2016). This study will focus on trust in close friends and family to cope with difficult times (e.g., the possibility of receiving financial help in times of need or having someone to care for children in an emergency) and community belonging, also including a domain of social cohesion from the Canadian Community Health Survey. Social capital will score between 0 (lowest social capital) and 10 (highest social capital), social cohesion between 8 (lowest cohesion) and 33 (highest cohesion), and community belonging between 6 (lowest belonging) and 24 (highest belonging).
Community capital
An ad-hoc tool will be developed to measure the use of community assets, here defined as "any factor (or resource) that enhances the capacity of individuals, groups, communities, populations, social systems and institutions to maintain and sustain health and well-being and helps them to reduce health inequalities", as well as potential barriers to their use. The tool will contain questions on community assets, classified into seven categories: 1. Natural, 2. Cultural, 3. Human, 4. Social, 5. Political, 6. Financial and 7. Built. Participants will be asked if they consider that their environment (this includes the neighbourhood where they live, and other places in the municipality that they frequent) has these community assets and how often they use them. The ad-hoc instrument will be pre-tested with a small representative sample of the community to obtain feedback on the clarity and relevance of the questions in order to make any necessary adjustments before its final implementation.
Knowledge, attitudes and practices on personal antibiotic use
Knowledge, attitudes and practices on personal antibiotic use will be measured using an instrument validated in Spain. This instrument will obtain data to analyse common antibiotic-related behaviours of the following three dimensions: knowledge (what respondents know about antibiotics), attitude (what respondents think about antibiotics) and practice (what they do regarding antibiotics). The different domains will be measured in a Likert scale from 0 to 10 with a final score between 0 (lowest knowledge, attitudes and practices on personal antibiotic use) and 160 (highest knowledge, attitudes and practices).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.