CITE: Clinical Inference Tethered to Evidence - a Retrieve-and-verify Layer for AI Care Plans (CITE)
16 juli 2026 bijgewerkt door: Sanjay Basu, Waymark
A Randomized Controlled Trial of CITE (Clinical Inference Tethered to Evidence), an Evidence-Grounding Retrieve-and-Verify Layer That Flags Unsupported and Inappropriate Recommendations in AI-Generated Care Plans, Versus AI With Safety Guardrails Alone and Unassisted Care, in Medicaid Primary Care
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Patients are randomized 1:1:1 to (1) unassisted clinician care; (2) AI-generated care plan with safety guardrails; (3) AI-generated care plan with safety guardrails plus CITE.
CITE audits the finalized plan against a frozen, versioned evidence corpus and returns physician-facing flags for patient-specific codifiable safety hazards (a recommended drug contraindicated by this patient's diagnosis or laboratory value; a drug-allergy conflict; a dropped high-risk medication; a guideline-indicated therapy omitted for an active diagnosis; a stated quantity refuted by the corpus), each with a verbatim quote and citation; the clinician retains decision authority.
Randomization uses a deterministic HMAC permuted-block scheme; outcome assessors are blinded to arm.
The co-primary outcomes are (1) the diagnostic accuracy (sensitivity and specificity) of CITE against blinded clinician adjudication, and (2) clinician alert burden (flags per encounter) and acceptance, comparing the CITE arm with the guardrail arm; both are estimable at the enrolled sample size because they do not depend on a rare between-arm event.
The unresolved codifiable-hazard rate by arm is reported as a descriptive secondary: codifiable hazards are infrequent, so the trial is not powered for a between-arm efficacy contrast on hazard reduction.
A prior trial of a different mechanism (a generic deterministic rule-corpus that surfaced roughly 30 or more flags per encounter and was uninformative) was completed with null results and is registered separately; this trial evaluates a materially different, patient-specific intervention and set of outcomes.
Determined exempt by WCG IRB (low risk).
Analysis is pre-registered on OSF (https://doi.org/10.17605/OSF.IO/ENXCW).
Studietype
Ingrijpend
Inschrijving (Geschat)
240
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
INCLUSION CRITERIA:
- 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.
EXCLUSION CRITERIA:
- 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.
- Enrollment in a competing AI-safety study within the prior 90 days.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: Arm 1: Unassisted care
Clinician develops the care plan without AI assistance.
|
|
|
Actieve vergelijker: Arm 2: AI with safety guardrails
AI-generated care plan produced with a safety-guardrail system prompt; no CITE.
|
AI-generated care plan produced under a safety-guardrail system prompt.
|
|
Experimenteel: Arm 3: AI with safety guardrails plus CITE
AI-generated care plan with safety guardrails, then passed through CITE, which flags unsupported/inappropriate recommendations with evidence citations for the clinician.
|
AI-generated care plan produced under a safety-guardrail system prompt.
Reads 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Diagnostic accuracy of CITE against clinician adjudication
Tijdsspanne: Day 1 (index primary care encounter)
|
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.
|
Day 1 (index primary care encounter)
|
|
Clinician alert burden (flags surfaced per encounter)
Tijdsspanne: Day 1 (index primary care 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.
|
Day 1 (index primary care encounter)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Clinician action on CITE flags
Tijdsspanne: Day 1 (index primary care encounter)
|
Proportion of CITE flags accepted vs overridden by the clinician, by flag type (commission, confabulation, unsupported, omission).
|
Day 1 (index primary care encounter)
|
|
Unresolved codifiable safety-hazard rate by arm (descriptive)
Tijdsspanne: Day 1 (index primary care encounter)
|
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.
|
Day 1 (index primary care encounter)
|
|
Correction of codifiable hazards within 30 days
Tijdsspanne: Up to 30 days after the index encounter
|
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.
|
Up to 30 days after the index encounter
|
|
Completed referrals within 30 days
Tijdsspanne: Up to 30 days after the index encounter
|
Proportion of initiated referrals completed within 30 days.
|
Up to 30 days after the index encounter
|
|
Clinical safety composite (exploratory)
Tijdsspanne: Day 1 (index primary care encounter)
|
Four-component clinical safety composite carried from the prior trial.
Pre-specified as exploratory; underpowered at the planned sample size.
|
Day 1 (index primary care encounter)
|
|
30-day acute care utilization (exploratory)
Tijdsspanne: Up to 30 days after the index encounter
|
Emergency department visits and hospitalizations within 30 days.
Exploratory.
|
Up to 30 days after the index encounter
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 september 2026
Primaire voltooiing (Geschat)
1 juni 2027
Studie voltooiing (Geschat)
1 september 2027
Studieregistratiedata
Eerst ingediend
13 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
16 juli 2026
Eerst geplaatst (Werkelijk)
22 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
22 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
16 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- CITE-2026-02
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
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