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

Bibliographic Data

ID19439367
AuthorsSohini Sengupta (0000-0002-3077-2883, a Center for Faculty Excellence , The University of North Carolina at Chapel Hill (UNC-CH) , Chapel Hill , USA, corresponding author), Bernard Lo (0000-0001-6210-9667, b Department of Medicine , University of California, San Francisco (UCSF) , San Francisco , CA , USA), Ronald P Strauss (c UNC Schools of Dentistry and Medicine , UNC-CH, Chapel Hill , NC , USA), Joseph J Eron (0000-0002-4938-0644, University of North Carolina Health Care), Joseph Eron (d Department of Medicine, Division of Infectious Diseases and Center for AIDS Research (CFAR) , UNC-CH, Chapel Hill , NC , USA), Allen L Gifford (0000-0001-6442-1128, e VA New England Healthcare System, Center for Healthcare Quality, Outcomes and Economic Research , Bedford , MA , USA)
Year2011
Volume23
Issue11
Pages1382-1391
Publication date2011-11-01
Peer ReviewedYes
Open AccessNo
TypeARTICLE
VenueAIDS Care (JOURNAL)
Journal identifiersISSN: 0954-0121 • E-ISSN: 1360-0451
PublisherInforma UK Limited (PUBLISHER • GB)
DOI10.1080/09540121.2011.565031
PMID22022848
PMCIDPMC3205427
OpenAlexW2056477408
LanguageEN
References cited12

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 three-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

Alternative medicine · Clinical trial · Comprehension · Family medicine · Informed consent · Psychological intervention · Randomized controlled trial · Ethics in Clinical Research · Medicine · Meta-analysis and systematic reviews · Nursing · Patient-Provider Communication in Healthcare · Psychology · Internal Medicine · Surgery

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