Assessment of delivery methods used in the informed consent process at a safety-net hospital

Abstract

Background: Informed consent is legally and ethically required before a patient undergoes an endoscopic procedure, yet current literature suggests that patient comprehension of key components of informed consent is poor.

Objective: To evaluate specific aspects of and patient satisfaction with the informed consent process in patients who attended an endoscopy education class versus gastroenterology clinic.

Design: Prospective survey that examined all components of the informed consent process.

Setting: Safety-net hospital.

Patients: Outpatients undergoing endoscopy.

Intervention: Endoscopy education class versus gastroenterology clinic.

Main outcome measurements: Patient recall of the components of and satisfaction with the informed consent process.

Results: A total of 301 patients completed the survey, 52.0% of whom attended and were consented in an endoscopy education class. Patients who attended an endoscopy education class reported that a greater number of individual components of the informed consent process were explained to them as compared with patients who were consented in clinic. In multivariate analysis, patients who attended an education class were more likely to recall having had the alternatives (odds ratio [OR] 4.8; 95% confidence interval [CI], 2.0-11.8), details of the procedure (OR 3.0; 95% CI, 1.3-6.8), and what to expect after the procedure (OR 3.0; 95% CI, 1.5-5.6) explained to them by a provider. These patients were more likely to know they could refuse the procedure (OR 4.1; 95% CI, 1.0-16.8), compared with patients consented in the gastroenterology clinic.

Limitations: Non-randomized trial.

Conclusion: Patients from a diverse, urban population who attended a multilingual endoscopy education class reported having more elements of the informed consent process explained to them compared with patients who were consented in gastroenterology clinic.