ABSTRACT
Aims: To evaluate the effectiveness of SinergiAPS (a patient-centred audit and feedback intervention) in improving patient safety in primary healthcare (PHC) centres. Method(s): We conducted a cluster randomized controlled clinical trial in 59 PHC centres in Spain. We audited all the participant centres, assessing their level of patient safety based on the administration of the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire to 75 patients/centre. Then, PHC centres were randomly allocated to receive the SinergiAPS intervention or usual care. Only the intervention centres were fed back with the audit results. They received: (1) a bespoke feedback report with quantitative (scale and item level scores) and qualitative (free text) results;(2) a set of educational materials (based on available evidence-based strategies for addressing patient safety problems);and (3) a structured template to record and monitor their safety improvement plans. The intervention was remotely delivered using a bespoke web tool. The primary outcome was patient safety culture among professionals (MOSPSC questionnaire). Secondary outcomes were patient-reported patient safety (mean scores of five PREOS-PC questionnaire scales), and rate of avoidable hospital admissions. After 12 months follow-up, we conducted 14 semi-structured qualitative interviews with PHC professionals to explore their perceptions of the intervention and to identify implementation barriers. Result(s): We successfully recruited 1053 professionals out of 1971 (53%) invited professionals (81% women;mean (SD) age 49 (10) years). The post-intervention followup rate was 75% (793/1053). No significant differences were observed at 12 months between groups in patient safety culture score (intervention: 3.60 [95%CI 3.55-3.64] vs. control: 3.64 [95%CI 3.60-3.68]), or in any of the secondary outcomes. The qualitative interviews revealed that the response to the COVID-19 pandemic (which in Spain started 6 weeks after starting to deliver feedback reports) severely limited the ability of PHC centres to use the intervention resources as planned. Despite its low ''reach'', the intervention presented high acceptability and perceived utility. Conclusion(s): In the context of a health emergency, SinergiAPS did not improve patient safety in Spanish PHC centres. Future studies are needed to evaluate its effectiveness in contexts more consistent with usual practice.