1090-P: RCT Design Risks Excluding Key Groups in Pediatric–Adult Transition Studies

Introduction: Importance of the patient-provider relationship in pediatric to adult clinic transitions is well recognized. Yet, there is a lack of evidence from randomized controlled trials (RCTs). We tested a new approach to moving endocrinology patients to adult care in an RCT. However, consent requirements of the RCT posed challenges. We therefore examined whether this skewed enrollment, inadvertently precluding the very patients we sought to assist.

Methods: Participants age ≥16 with a chronic endocrine condition transferring from Stanford's pediatric to adult endocrinology clinics were randomized 2:1 to "Guided Transfer" (starting care with an adult physician in the pediatric clinic before moving) or "Direct Referral" (beginning adult care in adult clinic). To identify potential biases after enrollment ceased in Nov 2023, we reviewed enrollment efforts, compared participants' demographics to the age-matched population of patients in the 4 most commonly referring clinics, and surveyed referring providers. Data collection on the primary outcome, attendance in two adult clinic visits, is ongoing.

Results: Of 119 candidates, 34% were unreachable despite 256 cumulative contact attempts. 45 enrollees were randomized to GT and 21 to DR; 82% had diabetes. Compared to the age-matched clinic population (n=2169), enrollees were significantly more white (59% vs 38%, p<0.001) and privately insured (73% vs 43%, p<0.001). Among providers (n=13), 85% felt GT provided a benefit to patients. Key themes regarding improvement areas included eliminating consent needs, including all participants in GT, and enhancing monitoring and communication methods.

Conclusion: RCTs are prone to recruitment and enrollment bias in this population, missing those who might benefit most from the intervention, such as harder to contact or underserved individuals. Providers recognized RCT challenges but still favored the GT approach. A single-arm QI-based study may reduce barriers and improve demographic representation.