USA flag logo/image

An Official Website of the United States Government

An Interactive Informed Consent Program for Cardiac Procedures

Award Information

Department of Health and Human Services
Award ID:
Program Year/Program:
2010 / STTR
Agency Tracking Number:
Solicitation Year:
Solicitation Topic Code:
Solicitation Number:
Small Business Information
ArchieMD, Inc
3600 FAU Blvd. Suite 201 Boca Raton, FL 33431-6474
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
Phase 2
Fiscal Year: 2010
Title: An Interactive Informed Consent Program for Cardiac Procedures
Agency: HHS
Contract: 2R42HL087488-02
Award Amount: $977,070.00


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 needto 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 informedconsent 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.

Principal Investigator:

Robert J. Levine

Business Contact:

Robert Levine
Small Business Information at Submission:

3600 FAU Blvd, Suite 201 Boca Raton, FL -

EIN/Tax ID: 151042688
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
Research Institution Information:
University Of Michigan
University Of Michigan
ANN ARBOR, MI 48109-