Pilot study demonstrating effectiveness of targeted education to improve informed consent understanding in AIDS clinical trials

Abstract

Assessing and improving informed consent understanding is equally important as obtaining consent from participants in clinical trial research, but developing interventions to target gaps in participants’ informed consent understanding remains a challenge. We used a randomized controlled study design to pilot test an educational intervention to improve actual informed consent understanding of new enrollees in the Adult AIDS Clinical Trial Group (AACTG). Questionnaires were administered to 24 enrollees to assess their baseline understanding on eight elements of informed consent associated with AIDS clinical trials. Enrollees who scored 18/21(85%) or less were randomly assigned to in-person, targeted education (intervention) or delayed education (control). Two follow-up assessments were administered. Repeated measures ANOVA was performed to determine intervention effectiveness in improving actual informed consent understanding over time. Actual understanding improved at the immediate post-intervention time point with a significant score difference of 2.5 when comparing the intervention and delayed groups. In addition, there was a significant score difference of 3.2 when comparing baseline to 3-month follow-up for the two groups, suggesting a statistically significant intervention effect to improve actual understanding of the basic elements of informed consent. The findings demonstrated that one-time targeted education can improve actual informed consent understanding one week after the intervention, but retention of these concepts may require periodic monitoring to ensure comprehension throughout the course of a clinical trial.

Multi-media Educational Tool Increases Knowledge of Clinical Trials in Uganda

“…Another recent study of a video intervention corroborated this finding [15]. Two recent publications on a targeted educational session and a video intervention to increase participant’s understanding of informed consent without the details of a particular clinical trial did show improved post-training scores in addition to retention of this information [16,17]. …”

Participant Comprehension of Research for Which They Volunteer: A Systematic Review

“…Wray () randomized cancer patients to a written booklet, tailored brochure, or patient‐specific information, and reported no differences among the groups in terms of comprehension. Sengupta () provided targeted education to improve the understanding of the eight basic elements of informed consent by addressing incorrect answers using the QuIC form (Joffe et al, ) at two different time periods for two groups (Sengupta, ). While the study reported improved understanding from baseline measurement, after 5 weeks, subject understanding waned to less than baseline (Sengupta, ).…”

Clinical Research: Comprehension of the Patient Information Leaflet and the Consent Form

“…The mean ± SD, CS achieved by the participants was 13.4 ± 2.9; median 14 (6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20). The highest correct responses were obtained for questions on background details (38%).…”

“…New enrolees in the Adult AIDS Clinical Trial Group (AACTG) were administered to assess their baseline understanding on eight elements of informed consent associated with AIDS clinical trials. 12 Enrollees who scored 85% or less were randomly assigned to in-person, targeted education (intervention) or delayed education (control). Two follow-up assessments were administered.…”