Cocreating Action to Improve Rationality in the Health System

NCT07237971 | Recruiting

• 2 other identifiers: Grant No. 101125843ERC-2023-COG 101125843
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Health-Related Quality-of-Life; Social Capital; Health Literacy; Community Based Participatory Research; Antibiotic Prescription; Mental Health Literacy; Cardio Vascular Disease; Antimicrobial Drug Resistance; Well-being; Health Equity

Keywords

Community health; Cocreation action; Health system; Health literacy; Social capital; Community capital; Antibiotic drug use; Cardiovascular drug use; Psychotropic drug use; Health-related quality of life; Health equity

Outcome Measures

Primary Outcomes (3)

• 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).

  5 years

• 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.

  5 years

• 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.

  5 years

Secondary Outcomes (10)

• Critical Health literacy

  5 years

• Social capital and community belonging

  5 years

• Community capital

  5 years

• Knowledge, attitudes and practices on personal antibiotic use

  5 years

• Mental health literacy

  5 years

Study Arms (1)

Cocreating process to improve rationality in the health system in a deprived neighborhood

EXPERIMENTAL

Other: Cocreation process

Interventions

Cocreation process OTHER

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.

Also known as: Community-based participatory research (CBPR)

Cocreating process to improve rationality in the health system in a deprived neighborhood

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

Study Sites (2)

Community

Elche, Alicante, 03206, Spain

RECRUITING

Community based. Municipal District 2 of Elche

Elche, Alicante, Spain

RECRUITING

Related Publications (10)

• Campos L, Dias P, Costa M, Rabin L, Miles R, Lestari S, Feraihan R, Pant N, Sriwichai N, Boonchieng W, Yu L. Mental health literacy questionnaire-short version for adults (MHLq-SVa): validation study in China, India, Indonesia, Portugal, Thailand, and the United States. BMC Psychiatry. 2022 Nov 16;22(1):713. doi: 10.1186/s12888-022-04308-0.

  PMID: 36384505 BACKGROUND

• INCB. (n.d.). Report of the International Narcotics Control Board for 2021.

  BACKGROUND

• World Health Organization - Regional Office for Europe. (2015). The European Mental Health Action Plan 2013-2020. World Health Organization, 19.

  BACKGROUND

• Roth GA, Mensah GA, Johnson CO, Addolorato G, Ammirati E, Baddour LM, Barengo NC, Beaton AZ, Benjamin EJ, Benziger CP, Bonny A, Brauer M, Brodmann M, Cahill TJ, Carapetis J, Catapano AL, Chugh SS, Cooper LT, Coresh J, Criqui M, DeCleene N, Eagle KA, Emmons-Bell S, Feigin VL, Fernandez-Sola J, Fowkes G, Gakidou E, Grundy SM, He FJ, Howard G, Hu F, Inker L, Karthikeyan G, Kassebaum N, Koroshetz W, Lavie C, Lloyd-Jones D, Lu HS, Mirijello A, Temesgen AM, Mokdad A, Moran AE, Muntner P, Narula J, Neal B, Ntsekhe M, Moraes de Oliveira G, Otto C, Owolabi M, Pratt M, Rajagopalan S, Reitsma M, Ribeiro ALP, Rigotti N, Rodgers A, Sable C, Shakil S, Sliwa-Hahnle K, Stark B, Sundstrom J, Timpel P, Tleyjeh IM, Valgimigli M, Vos T, Whelton PK, Yacoub M, Zuhlke L, Murray C, Fuster V; GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol. 2020 Dec 22;76(25):2982-3021. doi: 10.1016/j.jacc.2020.11.010.

  PMID: 33309175 BACKGROUND

• Selim AJ, Rothendler JA, Qian SX, Bailey HM, Kazis LE. The History and Applications of the Veterans RAND 12-Item Health Survey (VR-12). J Ambul Care Manage. 2022 Jul-Sep 01;45(3):161-170. doi: 10.1097/JAC.0000000000000420.

  PMID: 35612387 BACKGROUND

• Rosas LG, Rodriguez Espinosa P, Montes Jimenez F, King AC. The Role of Citizen Science in Promoting Health Equity. Annu Rev Public Health. 2022 Apr 5;43:215-234. doi: 10.1146/annurev-publhealth-090419-102856. Epub 2021 Nov 1.

  PMID: 34724389 BACKGROUND

• Israel BA, Coombe CM, Cheezum RR, Schulz AJ, McGranaghan RJ, Lichtenstein R, Reyes AG, Clement J, Burris A. Community-based participatory research: a capacity-building approach for policy advocacy aimed at eliminating health disparities. Am J Public Health. 2010 Nov;100(11):2094-102. doi: 10.2105/AJPH.2009.170506. Epub 2010 Sep 23.

  PMID: 20864728 BACKGROUND

• Chinn D. Critical health literacy: a review and critical analysis. Soc Sci Med. 2011 Jul;73(1):60-7. doi: 10.1016/j.socscimed.2011.04.004. Epub 2011 May 12.

  PMID: 21640456 BACKGROUND

• Villalonga-Olives E, Adams I, Kawachi I. The development of a bridging social capital questionnaire for use in population health research. SSM Popul Health. 2016 Aug 31;2:613-622. doi: 10.1016/j.ssmph.2016.08.008. eCollection 2016 Dec.

  PMID: 29349175 BACKGROUND

• Nutbeam, D. (2020). Health literacy as a public health goal: a challenge for contemporary health education and communication strategies into the 21st century. Health Promotion International, 15(3), 259-267.

  BACKGROUND

Related Links

• Website of the project

MeSH Terms

Interventions

Community-Based Participatory Research

Intervention Hierarchy (Ancestors)

Health Services Research; Health Care Quality, Access, and Evaluation

Central Study Contacts

Lucy A Parker, PhD

CONTACT

(0034)965919516; cair@umh.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No parties are masked.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: A community-based participatory research will be conducted 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 in an iterative manner over 3 years. The investigators will use some preliminary results from 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 (sociograms, interviews, and focus groups) to boost the cocreation process. Finally, the impact of the cocreated actions will analysed. This study will use a before-after comparison of survey indicators, an interrupted time-series analysis of health service data and qualitative analysis.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 20, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From October 2025 to April 2029
• Access Criteria: The Creative Commons Attribution 4.0 International (CC BY 4.0) license will be used for our anonymized data, which will be stored on Zenodo. This license allows others to use, reproduce and disseminate out data (free of charge for any user). Data will remain available indefinitely, but it will need researchers' permission by a written request. Any use of data should always include proper attribution and not modify the content. Any embargo will not be applied on the open data; however, an embargo on the raw data will be implemented until the main results are published in an open-access journal.

Locations

ES (2)