Effectivenness and Implementation of an Intervention to Improve Primary Care Patient Safety

Aims: To evaluate the effectiveness of SinergiAPS (a patient-centered audit and feedback intervention) in reducing avoidable hospital admission, and; to explore the factors that may affect its implementation. Design: 24-month, parallel, open-label, multicentre, pragmatic, hybrid type 1 randomized clinical trial. Setting, sample, and randomization: 118 primary healthcare centers from multiple regions in Spain will be randomly assigned (ratio 1:1) to two groups (control and intervention). The intervention group will receive two audits (baseline and intermediate at 12 months). The audits will consist of the administration of the PREOS-PC questionnaire (a measure of patient-reported patient safety) to a sample of around 100 patients per center. The intervention group will receive reports on the results of both audits, along with resources aimed at facilitating the design and implementation of safety improvement plans. The intervention will be deployed through the SinergiAPS web tool, developed and validated in previous projects. The control group will have access to the intervention after the end of the clinical trial (waitlist). Outcomes: Primary outcome: rate of avoidable hospitalizations (electronic health records). Secondary outcomes: patient-reported patient safety (PREOS-PC questionnaire); patient safety culture perceived by professionals (MOSPC questionnaire); adverse events experienced by healthcare professionals (ad hoc questionnaire); the number of safety improvement actions (ad hoc questionnaire). Outcome data will be collected at baseline and at 24 months follow-up. Implementation evaluation: Drawing on the CFIR model, we will collect and analyze qualitative (30 individual interviews, implementation logbooks) and quantitative (questionnaires for professionals from intervention centers, level of use of the SinergiAPS web tool) data to examine the implementation of the intervention in the Spanish primary healthcare centers.

NCT Number	NCT05958108
Lead Sponsor	Fundació d'investigació Sanitària de les Illes Balears Collaborators: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Instituto de Investigación Biomédica de Salamanca, Avedis Donabedian Research Institute, Andalusian School of Public Health, INSTITUTO DE INVESTIGACIÓN SANITARIA GALICIA SUR, GERENCIA ASISTENCIAL DE ATENCION PRIMARIA, MADRID HEALTH SERVICE (SERMAS), Instituto de Investigación Sanitaria Aragón, Instituto Muciano de Investigación Sanitaria
Conditions	Patient Safety
Enrollment	110 participants
Start Date	2023-09-01
Primary Completion	2026-02 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2024-12-12