CITE: Clinical Inference Tethered to Evidence - a Retrieve-and-verify Layer for AI Care Plans (CITE)

July 16, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA:

  1. Age 18 years or older.
  2. Medicaid-enrolled and attributed to a participating Waymark primary care site.
  3. Primary care encounter that requires clinical reasoning (not administrative-only).
  4. English-language clinical documentation.

EXCLUSION CRITERIA:

  1. Age less than 18 years.
  2. Hospice or palliative-care-exclusive care plan.
  3. Administrative-only or pharmacy-only encounter that does not surface a clinical decision to the supervising clinician.
  4. Encounter where the supervising clinician is the principal investigator.
  5. Enrollment in a competing AI-safety study within the prior 90 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Arm 1: Unassisted care
Clinician develops the care plan without AI assistance.
Active Comparator: Arm 2: AI with safety guardrails
AI-generated care plan produced with a safety-guardrail system prompt; no CITE.
Other: AI care plan with safety guardrails
AI-generated care plan produced under a safety-guardrail system prompt.
Experimental: 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.
Other: AI care plan with safety guardrails
AI-generated care plan produced under a safety-guardrail system prompt.
Other: CITE evidence-grounding retrieve-and-verify layer
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of CITE against clinician adjudication
Time Frame: 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)
Time Frame: 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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinician action on CITE flags
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Waymark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CITE-2026-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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