Development and validation of a stakeholder-driven, self-contained electronic informed consent platform for trio-based genomic research studies.

Increasingly long and complex informed consents have yielded studies demonstrating comparatively low participant comprehension and satisfaction with traditional face-to-face approaches. In parallel, interest in electronic consents for clinical and research genomics has steadily increased, yet limited data are available for trio-based genomic discovery studies. We describe the design, development, implementation, and validation of an electronic iConsent application for trio-based genomic research deployed to support genomic studies of cerebral palsy. iConsent development incorporated stakeholder perspectives including researchers, patient advocates, institutional review board members, and genomic data-sharing considerations. The iConsent platform integrated principles derived from prior electronic consenting research and elements of multimedia learning theory. Participant comprehension was assessed in an interactive teachback format. The iConsent application achieved nine of ten proposed desiderata for effective patient-focused electronic consenting for genomic research. Overall, participants demonstrated high comprehension and retention of key human subjects' considerations. Enrollees reported high levels of satisfaction with the iConsent, and we found that participant comprehension, iConsent clarity, privacy protections, and study goal explanations were associated with overall satisfaction. Although opportunities exist to optimize iConsent, we show that such an approach is feasible, can satisfy multiple stakeholder requirements, and can realize high participant satisfaction and comprehension while increasing study reach.

Improving Primary Care Adolescent Depression Screening and Initial Management: A Quality Improvement Study.

Although recommended, adolescent depression screening with appropriate initial management is challenging. This project aimed to improve adolescent depression screening rates during preventive care visits in 12 primary care clinics from 65.4% to 80%, increase the proportion of documented initial management for those with a positive screen from 69.5% to 85%, then sustain improvements for 12 months. Methods: This quality improvement project involved 12 urban primary care clinics serving >120,000 mostly Medicaid-enrolled patients and targeted adolescents 12-17 years. Interventions included standardized depression screening using tablets with electronic health record (EHR) capture and automated scoring, embedding screening results and initial management actions into the EHR, provider education, and individual clinician and clinic performance feedback. Results: After standardizing the approach to screening, the process mean depression screening rate was 91.9%. However, after adopting tablets into the clinic flow, there was an unexpected initial decrease in proportion with appropriately documented initial management plans, from 89.7% to 67.6%. In response to this special cause variation, there was additional provider feedback and education, and a redesign of the EHR flow related to the presentation of results and prompts for action after a positive screen. As a result, the proportion with appropriately documented initial management was 87.3% by project completion. Conclusions: Tablet-based screening with EHR scoring capture effectively increased depression screening rates but required significant additional work to improve initial management after a positive screen. A full system approach, including EHR modification, clinician education, and performance feedback, is needed to make meaningful, sustained improvements in comprehensive adolescent depression screening.