Improving health system responses when patients are harmed: a protocol for a multistage mixed-methods study

Area of Science:

• Healthcare quality improvement
• Patient safety research
• Health services research

Background:

• Patient safety incidents lead to significant harm and hospital admissions in high-income countries.
• Adverse event investigations are standard practice, yet their quality and effectiveness in preventing future harm remain unevaluated.
• There is a critical need for evidence-based guidance to enhance healthcare responses to adverse events.

Purpose of the Study:

• To develop consistent, informed, and robust best practice guidance for adverse event investigations.
• To improve the response, learning, and health system improvements following adverse events.
• To enhance patient safety by refining investigation processes.

Main Methods:

• A multistage mixed-methods design including literature reviews, quality assessment of investigation reports, policy reviews, and stakeholder focus groups/interviews.
• Data triangulation from stages 1-4 to inform guidance development.
• Co-design and feasibility testing of new investigation tools and guidance with healthcare staff and consumers.

Main Results:

• The study will assess the quality of 300 adverse event investigation reports.
• It will gather perspectives from 120-255 healthcare staff and 20-32 consumers impacted by adverse events.
• Findings will be synthesized to co-design practical investigation tools and guidance.

Conclusions:

• The developed guidance aims to standardize and improve the effectiveness of adverse event investigations.
• Enhanced investigations are expected to reduce preventable harm and improve patient safety.
• Dissemination through publications and conferences will promote national adoption of best practices.