Dissertations & Theses (Open Access)

Date of Award

Spring 5-2020

Degree Name

Doctor of Philosophy (PhD)

Advisor(s)

Robert Morgan, Phd

Second Advisor

Stephen H Linder Phd

Third Advisor

Osama Mikhail Phd

Abstract

The primary objective of this study was to determine whether participants who received an interactive electronic consent (EC) had a better understanding of a medical procedure (apheresis) compared to those who received the standard document (SD) consent. The study was conducted with apheresis donors whose responses were used to determine if the EC facilitated better comprehension and retention of consent information by the study participants than by SD consenting methods. By comprehension, the goal was to have participants who can understand, summarize, or make judgments based on the content presented in the informed consent. By retention, the goal was to see if participants could recognize and select information presented in the informed consent. The two primary endpoints were measured using the Quality of Informed Consent (QuIC) index: knowledge of the various facets of the procedure, including the purpose of treatment and rights (Part A), and understanding of the informed consent items (Part B). Secondary endpoints included the effect of EC vs. SD on decisional conflict, patient satisfaction, and anxiety, as well as preferences between the SD and electronic and whether participants who completed the EC consent were more likely to consent to the procedure. The specific aims of the study were: 1) Obtain post-consent comprehension and understanding, anxiety, and decisional uncertainty in participants who completed SD and EC consent. 2) Compare post-consent comprehension, retention, anxiety, and decisional uncertainty in participants who completed the SD and EC consents. a. Also, EC satisfaction with the delivery method was surveyed. The primary hypothesis was that participants who used the EC would perform better than those who used the SD informed consent across the following domains: 1) comprehension and retention; 2) decisional uncertainty; 3) anxiety, and 4) satisfaction.

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