(703) Quality Improvement Targeting Coordinator Approach to Promote Successful Clinical Trial Consent

Introduction: In 2022, the NIH spent $5.7 billion on child health research. While there is significant investment to pediatric clinical trials, inefficient resource utilization is demonstrated in discontinuation/nonpublication. Recommendations for study completion focus on trial design, enrollment window, and interventions, yet 11-19% of trials listed on ClinicalTrials.gov fail due to patient accrual. This quality initiative aimed to identify and assess environmental factors in the PICU at time of consent.

Methods: A quality improvement initiative, utilizing an inductive approach, was developed to understand environmental barriers to successful clinical trial consent in the PICU at a tertiary children’s hospital. In July 2022, PICU research coordinators (RCs) prospectively identified 24 environment measures surrounding consent. These data were collected over 3 months, initial data was analyzed and 5 areas were identified as potential contributors to successful consent, including Legal Guardian (LG) study comprehension, perception of LG feeling overwhelmed, consent environment, consent presentation length, and number of RCs present for consent. The RCs implemented interventions in each area, including, scripted presentations, LG readiness assessment to fully participate in consent and schedule alternate times, approached families when room activity was or moved consent location, increased consent length to 10-20 minutes, and aimed for 2 RCs present for consent. Over the following 9 months, consent measures were tracked. A z-test for proportions was used to assess the difference pre and post-intervention; alpha set at p < 0.05)

Results: Consent rates increased from 54% (n = 56) to 67% (n=93), p = 0.11 after implementation of 5 focused approaches to improve consent. Evaluating each successful approach pre- and post-intervention are as follows: study comprehension (69.44 vs 70.27%), consent environment (75 vs 78.38%), moderate to long consent (47.22 vs 62.17%), and 2-3 coordinators present (77.42 vs 72.27%).

Conclusions: While the bundled interventions increased the proportion of successful consents, the difference in consent rates were not significant, suggesting that the bundled interventions had minimal impact on consent rates. Further modifications to the consent process are needed to enhance consent rates.