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

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.

Conditions

• Patient Safety

Interventions

BEHAVIORAL

SinergiAPS intervention

Audit and feedback intervention, with the audit being based on patient-reported experiences and outcomes of patient safety.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  collaborator OTHER

• Instituto de Investigación Biomédica de Salamanca

  collaborator OTHER

• Avedis Donabedian Research Institute

  collaborator OTHER

• Andalusian School of Public Health

  collaborator OTHER_GOV

• INSTITUTO DE INVESTIGACIÓN SANITARIA GALICIA SUR

  collaborator UNKNOWN

• GERENCIA ASISTENCIAL DE ATENCION PRIMARIA, MADRID HEALTH SERVICE (SERMAS)

  collaborator UNKNOWN

• Instituto de Investigación Sanitaria Aragón

  collaborator OTHER

• Instituto Muciano de Investigación Sanitaria

  collaborator UNKNOWN

• Fundació d'investigació Sanitària de les Illes Balears

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-09-01

Primary Completion

2026-02-28

Completion

2026-06-30

Countries

• Spain

Study Locations