Converting the informed consent from a perfunctory process to an evidence-based foundation for patient decision...

Area of Science:

• Cardiology
• Medical Informatics
• Patient Communication

Background:

• Standard consent forms offer inconsistent patient-physician communication.
• Shared decision-making is crucial for invasive cardiac treatments.

Purpose of the Study:

• To assess the impact of the PREDICT program on the informed consent process for percutaneous coronary intervention.
• To compare patient experiences with traditional versus PREDICT-enhanced consent forms.

Main Methods:

• Developed PREDICT, a web-based program embedding patient-specific risk estimates (death, bleeding, restenosis) into consent documents.
• Compared patient-reported outcomes from original consent forms (n=142) with PREDICT forms (n=193).
• Utilized hierarchical modified Poisson regression to adjust for physician-based clustering.

Main Results:

• PREDICT group showed higher consent form reading rates (72% vs 44%) and increased shared decision-making perception (67% vs 45%).
• Anxiety levels decreased significantly in the PREDICT group (35% vs 55%).
• Patients receiving PREDICT forms had better recall of specific complication risks (e.g., death: 85% vs 62%).

Conclusions:

• Individualized consent forms incorporating patient-specific risks enhance participation and reduce anxiety.
• PREDICT demonstrates potential for improving informed consent in percutaneous coronary intervention.
• This preliminary study suggests a valuable strategy for patient-centered cardiovascular care.