• Am. J. Crit. Care · Mar 2015

    Randomized Controlled Trial

    A computer-based education intervention to enhance surrogates' informed consent for genomics research.

    • Ann K Shelton, Bradley D Freeman, Anne F Fish, Jean A Bachman, and Lloyd I Richardson.
    • Ann K. Shelton is an assistant professor, Department of Primary Care Nursing, School of Nursing, Southern Illinois University Edwardsville. Bradley D. Freeman is a professor, Division of General Surgery, Acute and Critical Care Surgery Section, Washington University School of Medicine, St Louis, Missouri. Anne F. Fish and Jean A. Bachman are associate professors, College of Nursing, and Lloyd I. Richardson is the Curator's Teaching Professor, College of Education, University of Missouri-St Louis, St Louis, Missouri. ashelto@siue.edu.
    • Am. J. Crit. Care. 2015 Mar 1;24(2):148-55.

    BackgroundMany research studies conducted today in critical care have a genomics component. Patients' surrogates asked to authorize participation in genomics research for a loved one in the intensive care unit may not be prepared to make informed decisions about a patient's participation in the research.ObjectivesTo examine the effectiveness of a new, computer-based education module on surrogates' understanding of the process of informed consent for genomics research.MethodsA pilot study was conducted with visitors in the waiting rooms of 2 intensive care units in a Midwestern tertiary care medical center. Visitors were randomly assigned to the experimental (education module plus a sample genomics consent form; n = 65) or the control (sample genomics consent form only; n = 69) group. Participants later completed a test on informed genomics consent.ResultsUnderstanding the process of informed consent was greater (P = .001) in the experimental group than in the control group. Specifically, compared with the control group, the experimental group had a greater understanding of 8 of 13 elements of informed consent: intended benefits of research (P = .02), definition of surrogate consenter (P= .001), withdrawal from the study (P = .001), explanation of risk (P = .002), purpose of the institutional review board (P = .001), definition of substituted judgment (P = .03), compensation for harm (P = .001), and alternative treatments (P = .004).ConclusionsComputer-based education modules may be an important addition to conventional approaches for obtaining informed consent in the intensive care unit. Preparing patients' family members who may consider serving as surrogate consenters is critical to facilitating genomics research in critical care.©2015 American Association of Critical-Care Nurses.

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