Informed consent for invasive procedures in a community hospital medical intensive care unit

To describe the informed consent practices in the medical intensive care unit (MICU) of a university-affiliated, community teaching hospital.

Prospective, observational study.

177 critically ill patients.

Study personnel identified all critically ill patients who had an invasive medical procedure during the study period (120 days). It was first determined whether written informed consent was obtained for the procedure. If it was, standardized questionnaires were used to determine whether consent-givers recalled the indications, complications, and alternatives of invasive medical procedures. Documentation of consent and of the performance of invasive procedures in the medical records was also examined. An educational in-service was created to help improve the informed consent process. After a 45-day lead-in (control) period, the in-service was administered and IC was again studied for 75 days.

A total of 181 procedures were performed on 112 patients over 120 days in the MICU. The rates of written consent for invasive procedures averaged 89%; rates of consent were not affected by the educational in-service. Following administration of the in-service, consent-givers recalled a greater number of complications (2.5 to 4.1, P=0.01) and documentation of consent improved.

These results suggest that informed consent can be obtained procedure-by-procedure, as needed, at a high frequency, and with reasonable consenter comprehension.