Supporting informed clinical trial decisions: Results from a randomized controlled trial evaluating a digital decision support tool for those with intellectual disability

• Published in: PloS one Vol. 14; no. 10; p. e0223801
• Main Authors: McCormack, Lauren A., Wylie, Amanda, Moultrie, Rebecca, Furberg, Robert D., Wheeler, Anne C., Treiman, Katherine, Bailey, Donald B., Raspa, Melissa
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 23.10.2019; Public Library of Science (PLoS)
• Subjects: Adolescent; Adult; Autism; Biology and Life Sciences; Child; Clinical decision making; Clinical trials; Cognitive ability; Communication; Cost-benefit analysis; Decision Making; Decision support systems; Decision Support Systems, Clinical; Disabilities; Ethics; Female; Fragile X syndrome; Health Knowledge, Attitudes, Practice; Humans; Informed Consent; Intellectual disabilities; Intellectual Disability - psychology; Intellectual Disability - therapy; Male; Medical research; Medical screening; Medicine and Health Sciences; Multimedia; Patient Participation - statistics & numerical data; Patient Selection; People and Places; Public health; Randomized Controlled Trials as Topic; Reasoning; Regression analysis; Research and Analysis Methods; Research Subjects - psychology; Researchers; Social Sciences; Surveys and Questionnaires; Systematic review; Young Adult; North Carolina; Los Angeles California; United States > US
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0223801

Informed consent requires that individuals understand the nature of the study, risks and benefits of participation. Individuals with intellectual disabilities (ID) have cognitive and adaptive impairments that may affect their ability to provide informed consent. New treatments and clinical trials for fragile X syndrome, the most commonly known inherited cause of ID, necessitate the development of methods to improve the informed consent process. The goal of this study was to compare the efficacy of a digital decision support tool with that of standard practice for informed consent and to examine whether the tool can improve decisional capacity for higher functioning individuals. Participants (N = 89; mean age = 21.2 years) were allocated to the experimental group (consenting information provided via the digital decision support tool), or the comparison group (information provided via standard practice). Participants were assessed on four aspects of decisional capacity (Understanding, Appreciating, Reasoning, and Expressing a choice). We used regression analyses to test the impact of the tool on each outcome, repeating the analyses on the higher functioning subsample. No differences existed in any domain of decisional capacity for the sample in full. However, participants in the higher IQ subsample who used the tool scored better on Understanding after adjustment (β = 0.25, p = 0.04), but not on Appreciating or Reasoning. No differences by experimental group existed in the decision to join the hypothetical trial for the full sample or higher functioning subsample. A decision support tool shows promise for individuals with fragile X syndrome with higher cognitive abilities. Future studies should examine the level of cognitive ability needed for sufficient understanding, whether these findings can be translated to other clinical populations, and the impact of the tool in larger trials and on trial retention.