RecruitingNot ApplicableNCT07237971

Cocreating Action to Improve Rationality in the Health System


Sponsor

Universidad Miguel Hernandez de Elche

Enrollment

4,000 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria13

  • Survey general population:
  • A representative population survey of adult (aged 18 years and over) who are residents in the Municipal District 2 of Elche (Spain).
  • Survey community pharmacies:
  • Individuals who visit the pharmacies collaborating in the Municipal District 2 of Elche (Spain) to obtain any of the medications, aged 18 years and over for three a priori established medication groups.
  • 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
  • Health service data from primary care:
  • A series of aggregate indicators will be collected from the electronic information systems of the regional health authorities (Conselleria de Sanidad de la Generalitat Valenciana), which hosts information on both prescriptions made by physicians and those dispensed in the community pharmacies of the Valencian Community. These indicators will be calculated for individuals aged 18 years and over for groups 2 and 3, and 12 years and over for group 1 using aggregate data from health system's registries and, therefore, not considering 12 years old as minimum age limit of the eligible participants in the present study protocol registry. Furthermore, aggregate data about the number of consultations will be collected in the two primary care facilities in the study area for individuals aged 18 and over.
  • Qualitative methods and cocreation procedure:
  • Focus groups, sociograms and in-depth interviews will include 6-8 participants and last approximately 90 minutes. Participation in the co-creation process will be open, voluntary, and will depend on the interest of individuals and entities in the area. Eligibility criteria:
  • 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.
  • Representatives from community institutions and associations, including professionals from the Elche Public Health Center, primary care teams in the area, Elche Council staff, as well as professionals and volunteers from NGOs and other local organizations with experience in community work in the district.

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Interventions

OTHERCocreation process

The 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.


Locations(2)

Community

Elche, Alicante, Spain

Community based. Municipal District 2 of Elche

Elche, Alicante, Spain

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NCT07237971


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