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BackgroundResearch participants often misunderstand the required elements of informed consent information, whether provided in written or oral format. Informed consent instruments with embedded evidence-based learning theory principles administered in multimedia electronic formats may improve comprehension and retention. ObjectiveThis study aims to determine whether study information comprehension and retention using an interactive multimedia video consent process was noninferior to comprehension and retention after an in-person face-to-face interaction with a conventional written consent document for caregivers and adolescents enrolled in a clinical trial. MethodsParticipants were caregivers and children aged 12 to 17 years who were enrolled in a clinical trial of asthma treatment. Consent information was presented as a multimedia web-based video consent interaction or as a conventional written consent document with in-person interaction between the prospective participants and the study staff. The trial used a parallel nonrandomized noninferiority design that compared the 2 consent methods. Caregivers and adolescents completed a 17-item open-ended comprehension questionnaire (score range 17-51) at enrollment and at the end of the study 20 weeks later. Comprehension and retention were compared between the consent formats. Noninferiority was established if the 95% CI upper bound of the difference in scores (conventional format minus web-based) was less than the noninferiority margin of 2.4; superiority was established if the upper bound of the CI was

Abstract Background The literature on the specification and measurement of the outcomes of the healthcare transition from pediatric to adult centered-care is scarce and methodologically weak. To address these gaps, we conducted a series of studies to develop a multidimensional, multi-informant (young adults, parents, and healthcare providers) measure of healthcare transition outcomes for young adults with type 1 diabetes (T1D), the Healthcare Transition Outcomes Inventory (HCTOI). The current study describes the development and refinement of the HCTOI item pool. Methods Following Patient Reported Outcomes Measurement Information System (PROMIS) standards, the research team conducted qualitative interviews to define six content domains of healthcare transition outcomes from the perspectives of multiple stakeholders, developed an initial item pool of the HCTOI based on the six domains, analyzed expert item ratings and feedback for content validation, and conducted cognitive interviews with informants (patients, parents, and healthcare providers) for further item pool refinement. Results Qualitative findings revealed six healthcare transition outcome domains: 1) Biomedical markers of T1D control; 2) Navigation of a new health care system; 3) Possession of T1D self-management skills and knowledge; 4) Integration of T1D care into emerging adult roles; 5) Balance of parental involvement with autonomy; and 6) Attainment of T1D “ownership.” An initial pool of 88 items focused on the extent to which a young adult with T1D is successful on each of the six domains. Experts rated all content domains and all but six items as relevant. In addition to suggesting additional items, experts were concerned about the length of the measure, response burden, and whether every informant type would have sufficient knowledge to rate items in particular content domains. Cognitive interviews resulted in retaining all six content domains, but dropping some items and yielded fewer items for the healthcare provider version (47 items versus 54 items for the young adult- and parent-versions). Conclusions Expert review and cognitive interviews confirmed that all six domains of HCT outcomes were relevant and both procedures resulted in retaining a sufficient number of clear and representative items for each content domain. The HCTOI represents the first multi-informant, rigorously developed item pool that comprehensively measures the multiple components of the transition from pediatric to adult specialty healthcare.

Decision aids (DAs) are central to shared decision making (SDM) interventions, yet little is known about patients’ actual DA use. Adequate utilization of DAs could optimize SDM effectiveness. Electronic DAs enable more objective tracking and analysis of actual DA utilization than do paper DAs. This report is part of an ongoing randomized controlled SDM trial enrolling adolescents with type 1 diabetes and their caregivers ( n = 153) who were considering use of an insulin pump or continuous glucose monitor. Extensive stakeholder engagement guided creation of two online DAs. After completing baseline measures, 133 dyads were randomized to SDM (access to the pertinent DA) or Usual Care (clinic routines for preparing candidates for adopting these devices). Utilization data showed that 80% of caregivers and 66% of youths logged into a DA at least once; youths and caregivers, respectively, dedicated a mean of 44.7 and 55.0 minutes to website use and viewed 72.2% and 77.4% of the DA content. Median total duration from enrollment to last DA logout was 48.2 days for adolescents and 45.6 days for caregivers. Bivariate comparisons showed that non-Hispanic, Caucasian females from households with higher socioeconomic status were significantly more likely to login to the assigned DA at least once. Hierarchical multiple regression showed that adolescent males with lower levels of health literacy demonstrated fewer DA logins ( F = 2.59; P < 0.009), but identified no significant predictors of adolescents’ or caregiver’ duration of DA use or proportion of DA content viewed. Future SDM trials should seek to promote DA use, especially by non-White adolescents, perhaps with direct assistance with the initial DA login. Trials employing electronic DAs should routinely report and analyze utilization data.