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A Comparison With Standard Information

Alan R. Tait, PhD; Terri Voepel-Lewis, MSN, RN; Mauro Moscucci, MD, MBA; Colleen M. Brennan-Martinez, BSN, MS; Robert Levine, MD

Arch Intern Med. 2009;169(20):1907-1914.

Background  Several studies suggest that standard verbal and written consent information for treatment is often poorly understood by patients and their families. The present study examines the effect of an interactive computer-based information program on patients' understanding of cardiac catheterization.

Methods  Adult patients scheduled to undergo diagnostic cardiac catheterization (n = 135) were randomized to receive details about the procedure using either standard institutional verbal and written information (SI) or interactive computerized information (ICI) preloaded on a laptop computer. Understanding was measured using semistructured interviews at baseline (ie, before information was given), immediately following cardiac catheterization (early understanding), and 2 weeks after the procedure (late understanding). The primary study outcome was the change from baseline to early understanding between groups.

Results  Subjects randomized to the ICI intervention had significantly greater improvement in understanding compared with those who received the SI (net change, 0.81; 95% confidence interval, 0.01-1.6). Significantly more subjects in the ICI group had complete understanding of the risks of cardiac catheterization (53.6% vs 23.1%) (P = .001) and options for treatment (63.2% vs 46.2%) (P = .048) compared with the SI group. Several predictors of improved understanding were identified, including baseline knowledge (P < .001), younger age (P = .002), and use of the ICI (P = .003).

Conclusions  Results suggest that an interactive computer-based information program for cardiac catheterization may be more effective in improving patient understanding than conventional written consent information. This technology, therefore, holds promise as a means of presenting understandable detailed information regarding a variety of medical treatments and procedures.

Author Affiliations: Departments of Anesthesiology (Dr Tait and Ms Voepel-Lewis) and Internal Medicine, Division of Cardiovascular Medicine (Dr Moscucci and Ms Brennan-Martinez), University of Michigan Health System, Ann Arbor; and the Emergency Care Center, Jackson Memorial Hospital, Miami, Florida, and ArchieMD Inc, Boca Raton, Florida (Dr Levine). Dr Moscucci is currently with the University of Miami Miller School of Medicine, Miami.

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Quandaries of Informed Consent: Comment on "Patient Comprehension of an Interactive, Computer-Based Information Program for Cardiac Catheterization"
Janice Lynn Hanson
Arch Intern Med. 2009;169(20):1914-1915.
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