Active — Not RecruitingPhase 3

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

Spain110 participantsStarted 2023-09-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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In this study, we will apply specific criteria for 1) primary health care centers (unit of randomization and analysis), and 2) primary care professionals, as detailed below: Inclusion Criteria for primary care CENTRES: We will include public primary healthcare centers from any autonomous community in Spain that willingly agree to participate through informed consent signed by the manager of the center. Exclusion Criteria for primary care CENTRES: * Centers that exclusively provide specific services (such as pediatrics or women's health centers) * Centers that have been established for less than 12 months at the time of recruitment Inclusion Criteria for primary care PROFESSIONALS: All professionals in primary care health centers meeting the criteria above described, including healthcare and non-healthcare professionals, who have been working at the center for at least 3 months will be invited to participate in the study. Exclusion Criteria for primary care PROFESSIONALS: * professionals declining to complete the baseline questionnaires. * professionals having been worked in the center for less than three months at the moment of recruitment

What they're measuring

Rate of avoidable hospitalizations

Timeframe: Baseline, and at 24 month follow-up

Trial details

NCT IDNCT05958108

SponsorFundació d'investigació Sanitària de les Illes Balears

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-02