The effect of the institutionalization of medical care on quality of patient's informed consent
Objectives. Informed Consent is an integral part of healthcare delivery in the U.S., and is expected to be obtained from patients prior to performing most medical procedures. This study aimed to construct and measure a multi-dimensional model of informed consent (IC), that includes measurement of Intention, Understanding and Controlling Influence, and to evaluate IC for women in the context of prenatal screening. This study also aims to model and measure the characteristics of an institutionalized medical procedure (the prenatal screen) and evaluate the effects of the institutionalization of this procedure on patient IC for the procedure.
Methods. Obstetrician's (n=31) and their patients (n=273) at ten obstetrics practices were asked to fill out questionnaires at the time the blood draw for the prenatal screen would occur. The primary outcome measure is whether criteria of informed consent (intention, understanding, freedom from controlling influence) for the screen was met. Further analysis evaluates the relationship between the characteristics of the screen as an institutionalized medical procedure and IC.
Results. Fifty seven percent of patient respondents do not give a consent that is considered an informed consent. The criteria for Intention is not met for 31% of respondents, the criteria for Understanding is not met for 45% of respondents and 8% of respondents experience some form of Controlling Influence. Patient perception of the prenatal screen as something that is performed routinely, without need for deliberation, is a predictor of IC not being met.
Conclusion. Informed consent not being given by 57% of patients for a procedure that is considered standard for all pregnant women. This research indicates a need for improvement in obtaining informed consent or informed refusal for prenatal screening, and also suggests that it is the very routine and standard nature of the screen that may be a factor in compromised IC for the screen. Continued and further evaluation of the quality of informed consent for both routine and non-routine medical procedures in clinical practice is warranted.
Health care management;
Quality of care
0573: Public health
0769: Health care management