An Interactive Informed Consent Program for Cardiac Procedures

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R42HL087488-02
Agency Tracking Number: R42HL087488
Amount: $977,070.00
Phase: Phase II
Program: STTR
Awards Year: 2010
Solicitation Year: 2010
Solicitation Topic Code: NHLBI
Solicitation Number: PHS2010-2
Small Business Information
3600 FAU Blvd, Suite 201, Boca Raton, FL, -
DUNS: 157649471
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 ROBERT LEVINE
 (561) 391-4448
 RLEVINE@ARCHIEMD.COM
Business Contact
 ROBERT LEVINE
Phone: (313) 764-1817
Email: rlevine@archiemd.com
Research Institution
 University Of Michigan
 University Of Michigan
ANN ARBOR, MI, 48109-
 () -
 Nonprofit college or university
Abstract
DESCRIPTION (provided by applicant): Informed consent has become an essential component of the doctor-patient interaction. The informed consent process requires that patients not only be given information about proposed medical treatment, but that it be presented in an understandable way so the patient can make meaningful choices about medical alternatives. At the heart of the informed consent doctrine, is the notion that the patient understands the procedure/therapy as well as its benefits and risks. Unfortunately, this is frequently not the case. Indeed, several studies suggest that many patients do not understand, recall, or even read the consent form. To ensure understanding of informed consent, didactic alternatives to the current informed process need to be applied. Under the Phase I STTR grant, ArchieMD, Inc. developed a novel prototype for an interactive multimedia computer-based cardiac catheterization consent program. The prototype was evaluated by the University of Michigan to determine the differential effectiveness of the interactive animated computer-based consent program for cardiac catheterization as compared to a commonly used verbal and written consent process. The evaluation revealed that patients who participated in the interactive informed consent exercise had significantly (Plt 0.05) greater improvement in understanding from baseline compared to those who received the standardized informed consent (particularly in the areas of risks of cardiac catheterization and the options for treatment). During Phase II, ArchieMD will revise the prototype based on Phase I findings, expand the procedures covered, develop post-operative education modules, and conduct expanded evaluations. PUBLIC HEALTH RELEVANCE: This project will contribute to public health by improving the quality of understanding achieved during informed consent. This may improved patients medical decision making, decrease medical litigation, and improve enrollment for clinical trials.

* Information listed above is at the time of submission. *

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