ANCHOR (Auditable Navigation of Clinical Hazards With Oversight and Reasoning) Multicenter Randomized Validation Study: A Pragmatic Three-Arm (1:1:1) Patient-Level Randomized Controlled Trial of a Structural Verification Layer for AI-Assisted High-Risk Multidisciplinary Care Across Three U.S. States
Abstract
This pre-registered, pragmatic, three-arm (1:1:1) patient-level randomized controlled trial with mixed-effects analysis at the encounter level tests two questions in real high-risk multidisciplinary clinical encounters at the Waymark clinically integrated network across three U.S. states (Ohio, Washington, Virginia): (1) does adding ANCHOR - a clinical AI structural verification layer - to a Gemini 3.1 Pro-assisted supervising-physician workflow reduce the rate of clinically meaningful safety failures, compared with the same Gemini 3.1 Pro-assisted workflow without ANCHOR? (2) does the Gemini 3.1 Pro-assisted workflow itself reduce the same safety endpoint compared with unassisted standard care in which the supervising physician writes their own SOAP assessment/plan from a blank template?
ANCHOR is a single-call structural verification layer combining a Logical Neural Network (Riegel et al. 2020) certificate, six specialist agents, and concept-decomposed output with PMID citation provenance. ANCHOR is physician-facing only and is used by supervising physicians, not by the multidisciplinary clinical team they oversee.
The trial randomizes 240 patients 1:1:1 across the Waymark clinically integrated network over a 12-week active-enrolment window (80 per arm). Eligible patients are adults (age 18+) identified as high-risk by combined claims-based and clinical criteria. Eligible encounters span three integrated Waymark service modalities: high-risk primary care, specialty care…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 240 participants or records.
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