10526 Background: Early identification of hereditary breast and ovarian cancer syndrome (HBOCS) in primary gynecological care is essential for timely referral to specialized counseling and risk-adapted prevention. Yet, identification mostly occurs after disease onset, thereby thwarting preventive efforts. To facilitate early identification of healthy HBOCS carriers along the HBOCS care pathway in Germany, we developed a modular cross-sectoral digital care platform (dVP_FAM). This study compared the impact of dVP_FAM with standard care on increasing the proportion of healthy individuals with HBOCS. This project was funded by the Innovation Fund of the German Federal Joint Committee. Methods: We conducted a two-arm, cluster-randomized trial including 42 primary gynecological centers (20 intervention, 22 control) in Germany. In the intervention centers, patients filled out a digital HBOCS screening questionnaire based on the inclusion criteria of the German Consortium HBOC. Results were reviewed and validated by primary care gynecologists, who then decided whether to initiate referral to a specialized HBOC center via the digital platform. Control centers followed usual care. A mixed-effects logistic regression model with random intercepts was used to account for clustering at the study center level. Odds ratios (ORs) and 95% confidence intervals were estimated. Results: In the intervention centers, 5.534 individuals completed digital screening; 1.116 (20.2%) met inclusion criteria (IC+), and 507 (9.2%) were uncertain about family history. Of these 1.623 individuals, 664 requested an appointment at an HBOC center. A total of 467 individuals (intervention group (IG): n = 329, mean age = 45.6 (SD 12.3), 99.4% female; control group (CG): n = 138, mean age = 46.2 (SD 13.5), 99.3% female) met the primary endpoint. Among IG, 282 participants (85.7%; [83.3%, 88.6%]) were healthy at the initial counseling at the HBOC center compared with 110 participants (79.7%; [73.5%, 84.7%]) in the CG. After adjusting for center effects, the observed odds of healthy counselees were lower in the CG than in the IG (OR = 0.67; 95% CI, 0.28–1.59; p = 0.368). Conclusions: The IG showed a higher proportion of healthy individuals at risk for HBOCS. Although not significant, this trend may suggest that supporting primary care physicians with a digital screening platform facilitates early identification of HBOCS within cross-sectoral care pathways. Clinical trial information: DRKS00030371.
