Document Type

Dissertation

Degree

Doctor of Philosophy

Major

Nursing

Date of Defense

12-5-2009

Graduate Advisor

Anne Fish, PhD, RN

Committee

Jean A. Bachman, DNS. RN

Ruth L. Jenkins, PhD, RN

J Perren Cobb, MD

Abstract

Background: A significant and growing number of clinical research studies conducted in Intensive Care Units (ICUs) today have some genetic and genomics component. Surrogates approached to authorize participation in clinical research for a loved-one in the ICU may not be prepared to make informed decisions. A model of stewardship of genetic and genomics research was used as a framework for this study. Purpose: The purpose of this investigation was to examine the effect of an educational program, the Interactive Computerized Information for Surrogates (ICIS) ICU Education Program in assisting surrogates to (1) increase their understanding of the process of informed consent and (2) increase their knowledge of genetic and genomics research. Methods: Visitors in two ICU waiting rooms (potential surrogates) in a large metropolitan medical center were randomly assigned to an experimental group (n = 64) who received the ICIS plus the Sample Consent Form and the control group (n = 69) who received the Sample Consent Form alone. Both groups completed the Posttest Instrument (α = .730). Results: Overall, understanding the process of informed consent was significantly higher (p = .05) in the experimental versus the control group (Wilcoxon W = 3346; p = 0.000). In addition, knowledge of genetics and genomics research was significantly higher (p = .05) in the experimental versus the control group (Wilcoxon W 3853.5, p = 0.000). The ICIS plus the Sample Consent Form was superior to the Sample Consent Form alone in 9 of the 14 items on the Posttest Instrument in increasing the understanding of the process of informed consent and in increasing the knowledge of genetic and genomics research in surrogates. Based on study findings, the ICIS was a feasible, useful, and effective program when used to educate surrogates about informed consent and genetic and genomics research in the ICU. A recommendation was made to administer the ICIS to surrogates prior to asking them to sign the Sample Consent Form.

Included in

Nursing Commons

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