CITE: Clinical Inference Tethered to Evidence - a Retrieve-and-verify Layer for AI Care Plans (CITE)
16 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Intervention / Traitement
Description détaillée
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).
Type d'étude
Interventionnel
Inscription (Estimé)
240
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Arm 1: Unassisted care
Clinician develops the care plan without AI assistance.
|
|
|
Comparateur actif: 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.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Diagnostic accuracy of CITE against clinician adjudication
Délai: 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)
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinician action on CITE flags
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
1 juin 2027
Achèvement de l'étude (Estimé)
1 septembre 2027
Dates d'inscription aux études
Première soumission
13 juillet 2026
Première soumission répondant aux critères de contrôle qualité
16 juillet 2026
Première publication (Réel)
22 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- CITE-2026-02
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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