Informed consent when prescribing medication: a randomized controlled trial.

Area of Science:

• Pharmacology
• Patient Safety
• Medical Education

Background:

• Informed consent is crucial for patient safety and understanding medication risks.
• Effective communication of adverse drug reactions (ADRs) is essential for adherence and informed decision-making.
• Patient recall of medication risks can be limited, impacting the informed consent process.

Purpose of the Study:

• To evaluate patient recall of specific risks associated with prednisone prescriptions.
• To determine if patient handouts enhance the informed consent process for medications.

Main Methods:

• A double-blinded, randomized controlled trial was conducted.
• Participants received either a verbal discussion of prednisone risks plus a handout, or a verbal discussion alone.
• Patient recall of discussed risks was assessed via telephone interview 2-4 weeks post-intervention.

Main Results:

• Both groups demonstrated low spontaneous recall of prednisone risks.
• The handout group recalled discussing significantly more risks with their physician compared to the control group.
• Demographics between the two groups were comparable.

Conclusions:

• Patients exhibit poor recall of discussed medication risks shortly after the informed consent process.
• Patient handouts may improve recall of discussed adverse drug reactions but do not fully resolve recall limitations.
• The utility of handouts in augmenting the informed medication consent process requires further investigation.