AUTHOR=Fiol-deRoque Maria A. , Mansilla Georgina Vidal , Maderuelo-Fernández José A. , Tamayo-Morales Olaya , Martín-Luján Francisco , Astier-Peña Pilar , Chacón-Docampo Macarena , Orrego Carola , Gens-Barberà Montserrat , Andreu-Rodrigo Pilar , Ricci-Cabello Ignacio , the SinergiAPS team , Mateo Alba Jiménez , Garza; Alexandre Varela , Tuñe Ana Arceo , Ramírez Puerta; Ana Belén , Fontán Ana Clavería , Carou Ana Isabel Castaño , Arroyo Ana María Reales , Covela Andrea Rodríguez , Bordas Anna , Ramirez Anna Mª , Olry de Labry Antonio , García-Iglesias Arancha , Martín Aurora Bárbara , Formoso Clara Gonzalez , Lugones-Sánchez Cristina , Freire Encarna Sánchez , Galindo Enrique Casado , Martín Eva , Álvarez-Guisasola Fernando , Deibe Fernando Lago , Vall Helena , Repiso-Gento Irene , Valderas Martinez Jose Maria , Sierra Leticia , Oliver Lourdes Luzón , García-Ortiz Luis , Martínez Mari Mar , Marin Maria de las Nieves Costa , Rodríguez Pablo Lorenzo , Rodríguez Ricardo , Campos Rocío Zamanillo , Bernat Sara Maria Guerrero , Torres Sara Martínez , Alonso Tamara , Ling Yoe , Blanco María José , Dorado Maribel TITLE=Evaluation of SINERGIAPS, an intervention to improve patient safety in primary healthcare centers in Spain based on patients’ perceptions and experiences: a protocol for a hybrid type I randomized clinical trial JOURNAL=Frontiers in Public Health VOLUME=12 YEAR=2024 URL=https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1324940 DOI=10.3389/fpubh.2024.1324940 ISSN=2296-2565 ABSTRACT=Background

Adverse events in the primary care setting result in a direct cost equivalent to at least 2.5% of total healthcare spending. Across OECD countries, they lead to more than seven million avoidable hospital admissions annually. In this manuscript, we describe the protocol of a trial aimed at evaluating the effectiveness of SinergiAPS (a patient-centered audit and feedback intervention) in reducing avoidable hospital admission and explore the factors that may affect its implementation.

Methods

We will conduct a 24-month, parallel, open-label, multicenter, pragmatic, hybrid type 1 randomized clinical trial. 118 primary healthcare centers with wide geographical distribution in Spain will be randomly assigned (ratio 1:1) to two groups. The intervention group will receive two audits (baseline and intermediate at 12 months) based on information collected through the administration of the PREOS-PC questionnaire (a measure of patient-reported patient safety) to a convenience sample of 100 patients per center. The intervention group will receive reports on the results of both audits, along with educational resources aimed at facilitating the design and implementation of safety improvement plans. The control group will receive care as usual. The primary outcome will be the rate of avoidable hospitalizations (administrative data). Secondary outcomes: patient-reported patient safety experiences and outcomes (PREOS-PC questionnaire); patient safety culture as perceived by professionals (MOSPSC questionnaire); adverse events reported by healthcare professionals (ad hoc questionnaire); the number of safety improvement actions which the re has implemented (ad hoc questionnaire). Outcome data will be collected at baseline and 24 months follow-up. For the evaluation of the implementation of the SinergiAPS intervention, we will draw on the Consolidated Framework for Implementation Research (CFIR). We will collect and analyze qualitative and quantitative data (30 individual interviews, implementation logbooks; questionnaires for professionals from intervention centers, and level of use of the SinergiAPS web tool).

Discussion

This study will expand the scarce body of evidence existing regarding the effects and implementation of interventions aimed at promoting patient and family engagement in primary healthcare, specifically for enhancing patient safety. The study has the potential to produce an impact on clinical practice, healthcare systems, and population health.

Clinical Trial Registration: https://clinicaltrials.gov/study/NCT05958108?term=sinergiAPS&rank=1 (NCT05958108).