CITE: Clinical Inference Tethered to Evidence - a Retrieve-and-verify Layer for AI Care Plans
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWaymark
About this trial
This trial evaluates CITE, a retrieve-and-verify layer that audits an AI-generated care plan against a full-text evidence corpus and flags patient-specific codifiable safety hazards to the clinician. The co-primary outcomes are how accurately CITE flags these hazards (sensitivity and specificity versus blinded clinician adjudication) and its clinician alert burden and acceptance, compared with AI care plans using safety guardrails alone and with unassisted clinician care, in Medicaid primary care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Medicaid-enrolled and attributed to a participating Waymark primary care site.
Primary care encounter that requires clinical reasoning (not administrative-only).
English-language clinical documentation.
Disqualifiers
Age less than 18 years.
Hospice or palliative-care-exclusive care plan.
Administrative-only or pharmacy-only encounter that does not surface a clinical decision to the supervising clinician.
Encounter where the supervising clinician is the principal investigator.
Trial design
Design model
Parallel
Treatments tested in this trial
CITE evidence-grounding retrieve-and-verify layer
Other interventionReads the AI care-plan text and verifies each recommendation/claim against a full-text evidence corpus; returns physician-facing flags (commission/confabulation/unsupported/omission) with verbatim quotes and citations. Clinician retains decision authority.
AI care plan with safety guardrails
Other interventionAI-generated care plan produced under a safety-guardrail system prompt.
Treatment groups
240 Participants
are divided into 3 treatment groupsGroup A: Arm 1: Unassisted careNo intervention 0 interventions
Group B: Arm 2: AI with safety guardrailsActive comparator 1 intervention
Group C: Arm 3: AI with safety guardrails plus CITEExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Diagnostic accuracy of CITE against clinician adjudication
Sensitivity and specificity (with positive and negative predictive values) of the CITE checker for clinically consequential codifiable safety hazards, using blinded clinician adjudication of the plan as the reference standard. Every plan contributes, so the estimate does not depend on a rare between-arm event. Exact-binomial 95% confidence intervals; reported overall and by hazard family.
Time frame
Day 1 (index primary care encounter)2
Clinician alert burden (flags surfaced per encounter)
Number of safety flags surfaced to the clinician per encounter in the CITE arm versus the guardrail arm, with clinician acceptance rate. Co-primary usability outcome: a verifier that surfaces an unmanageable number of flags is not deployable regardless of sensitivity (the prior-trial mechanism surfaced a median of about 30 per encounter). Pre-registered acceptability ceiling: median CITE flags per encounter at or below three.
Time frame
Day 1 (index primary care encounter)Secondary outcomes
1
Clinician action on CITE flags
Proportion of CITE flags accepted vs overridden by the clinician, by flag type (commission, confabulation, unsupported, omission).
Time frame
Day 1 (index primary care encounter)2
Unresolved codifiable safety-hazard rate by arm (descriptive)
Proportion of patient-specific codifiable-hazard checkpoints with an unresolved hazard in the finalized plan, by arm, with the Arm 3 minus Arm 2 difference and 95% confidence interval. Pre-specified as descriptive and hypothesis-generating: codifiable hazards are infrequent, so the trial is not powered for a between-arm efficacy contrast on this measure at the enrolled sample size.
Time frame
Day 1 (index primary care encounter)3
Correction of codifiable hazards within 30 days
Among checkpoints with a hazard in the finalized plan, the proportion acted on and corrected within 30 days (documented resolution, completed referral, or corrected order). Proximal clinical effectiveness measure.
Time frame
Up to 30 days after the index encounter4
Completed referrals within 30 days
Proportion of initiated referrals completed within 30 days.
Time frame
Up to 30 days after the index encounterLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Waymark
Lead sponsor
University of California, San Francisco
Sponsor institution
University of California, San Francisco
Collaborator
Source ClinicalTrials.gov
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