CompletedNANCT07597499

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

Sponsor: Waymark

Trial Details

ConditionHigh-Risk Multidisciplinary Care, Clinical Decision Support, Artificial Intelligence-Assisted Care, Telemedicine
InterventionGemini 3.1 Pro with Safety Prompt; ANCHOR Clinical AI Verification Layer (with Gemini 3.1 Pro)
PhaseNA
StatusCompleted
Participants240
Est. Completion1 Nov 2026
Last Updated8 July 2026

Primary Outcome

Per-encounter clinical safety failure (adjudicated binary composite)

Eligibility Criteria

Inclusion Criteria

INCLUSION CRITERIA: 1. Age 18 years or older. 2. Attributed to a participating Waymark provider (academic medical center, community-hospital network, federally qualified health center, or independent physician practice in Ohio, Washington, or Virginia; full TIN-consolidated list deposited at the Open Science Framework). 3. Meets high-risk multidisciplinary criteria (combined claims-based and clinical: 2 or more emergency-department visits or 1 or more hospitalization in the prior 12 months, 5 or more active medications, 2 or more active specialist relationships, 2 or more chronic conditions, or claims-based equivalents). 4. Encounter occurs in one of the three Waymark service modalities: high-risk primary care, specialty care coordination, or real-time telemedicine urgent care. 5. English-language clinical documentation. 6. Encounter requires clinical reasoning (not administrative-only). EXCLUSION CRITERIA: 1. Pediatric (age less than 18 years). 2. Hospice or palliative-care-exclusive care plan. 3. Active psychiatric crisis routed to crisis line. 4. Encounter is administrative only. 5. Pharmacy-only encounter that does not surface a clinical decision to the supervising physician. 6. Encounter where the supervising physician is the principal investigator. 7. Patient enrolled in a competing AI-safety study within the prior 90 days.

Trial Sites

Countries

United States
View Registry Entry

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