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

Abstract

BackgroundInformed 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.MethodsParticipants (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.ResultsNo 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.ConclusionsA 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.

Participation in collaborative projects as a precursor of trust in organizations for individuals with intellectual disability

“…Response rate was higher than 90% for both professionals and family members. Contact employees were also responsible for the distribution, explanation, and collection of signed informed consent forms in their centers, following the required ethical rules [ 17 ]. They explained the objectives and procedures of the research to all the participants in their centers.…”

Enrolling Children in Clinical Trials for Genetic Neurodevelopmental Conditions: Ethics, Parental Decisions, and Children's Identities

“…Even with a relatively well‐described condition such as fragile X syndrome, individuals vary widely in cognitive functioning from mildly to severely affected. Digital support tools may provide an interactive and accessible option for adolescents and adults with limited decisional capacity to participate in the consent processes, enhancing shared decision‐making between affected individuals and their parents 49 . These tools use interactive multimedia (audio, visual, and narration) with features such as an avatar that walks participants through the consent process, sorting exercises to engage participants in the decision, and knowledge checks.…”

Making Clinical Trials More Patient-Centered Using Digital Interactive E-Consent Tools

“…One randomized study of a hypothetical clinical trial compared standard paper consent to e-consent paired with a digital, interactive education tool for adults with intellectual impairment associated with fragile X syndrome. 34 The digital tool included dual-channel delivery of information, interactive elements to illustrate the main concepts of consent and a quiz to check for understanding. Use of the tool by adults with fragile X syndrome was shown to result in enhanced understanding among a subgroup of participants.…”

“…Use of the tool by adults with fragile X syndrome was shown to result in enhanced understanding among a subgroup of participants. The combination of e-consent elements (dual-channel information, interactive elements and a quiz) is likely to be the driving factor enhancing understanding 34 though individual elements may be more impactful for certain individuals. Research is needed to examine the e-consent process relative to the standard consent process for individuals with cognitive impairments as well also those without including the user experience.…”

“…Our research has found that higher functioning individuals with fragile X syndrome were more likely to understand the concrete elements of the trial and higher understanding was a significant predictor of appreciation (i.e., one's ability to link the decision to one's one situation). 34 The digital tool, Consenter, has since been updated and its capacity expanded. It is available through RTI International as a customizable decision tool to achieve informed consent for clinical trials enrolling those with intellectual impairment participants as well as those without cognitive challenges (https://www.consenter.org/).…”