Cluster randomized, controlled trial on patient safety improvement in general practice: a study protocol.

Area of Science:

• Healthcare Management
• Patient Safety
• Organizational Culture

Background:

• A strong safety culture is crucial for patient safety in healthcare.
• While hospital strategies are studied, effective primary care interventions remain underexplored.
• This study addresses the gap in understanding patient safety culture improvement in primary care.

Purpose of the Study:

• To evaluate the impact of the SCOPE questionnaire alone on patient safety culture.
• To assess the combined effect of the SCOPE questionnaire and a patient safety workshop.
• To provide evidence for effective patient safety tools in primary care settings.

Main Methods:

• A cluster randomized controlled trial involving 30 general practices in the Netherlands.
• Intervention arms: SCOPE questionnaire with feedback, or SCOPE questionnaire with a workshop.
• Control arm: usual care. Data collected at baseline and follow-up over one year.

Main Results:

• The study aims to provide insights into the effectiveness of different patient safety culture interventions.
• Primary outcome: reported incidents; secondary outcomes: quality/safety indicators and safety culture.
• Qualitative data from interviews will evaluate the implementation process.

Conclusions:

• Findings will elucidate the impact of a patient safety questionnaire versus a questionnaire combined with a workshop.
• Results will inform the implementation of patient safety tools and guide future research.
• The study acknowledges its strengths and limitations to contextualize findings.