Quality of Health CareCITENCT07718893
CITE: Clinical Inference Tethered to Evidence - a Retrieve-and-verify Layer for AI Care Plans
A study testing CITE evidence-grounding retrieve-and-verify layer and AI care plan with safety guardrails in people with Quality of Health Care and Patient Safety, run by Waymark at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Health Care, Patient Safety, Clinical Decision Support
- What is being tested?
- CITE evidence-grounding retrieve-and-verify layer and AI care plan with safety guardrails
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2026to 17 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Being tested
- CITE evidence-grounding retrieve-and-verify layer, AI care plan with safety guardrails
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CITE evidence-grounding retrieve-and-verify layerOther
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.
AI care plan with safety guardrailsOther
AI-generated care plan produced under a safety-guardrail system prompt.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Unassisted care | No intervention | Clinician develops the care plan without AI assistance. |
| Arm 2: AI with safety guardrails | Active comparator | AI-generated care plan produced with a safety-guardrail system prompt; no CITE. Receives: Other: AI care plan with safety guardrails |
| Arm 3: AI with safety guardrails plus CITE | Experimental | AI-generated care plan with safety guardrails, then passed through CITE, which flags unsupported/inappropriate recommendations with evidence citations for the clinician. Receives: Other: CITE evidence-grounding retrieve-and-verify layer; Other: AI care plan with safety guardrails |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (index primary care encounter)
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.
Measured: Day 1 (index primary care encounter)
Secondary outcomes (6)
Clinician action on CITE flags
Proportion of CITE flags accepted vs overridden by the clinician, by flag type (commission, confabulation, unsupported, omission).
Measured: Day 1 (index primary care encounter)
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.
Measured: Day 1 (index primary care encounter)
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.
Measured: Up to 30 days after the index encounter
Completed referrals within 30 days
Proportion of initiated referrals completed within 30 days.
Measured: Up to 30 days after the index encounter
Clinical safety composite (exploratory)
Four-component clinical safety composite carried from the prior trial. Pre-specified as exploratory; underpowered at the planned sample size.
Measured: Day 1 (index primary care encounter)
30-day acute care utilization (exploratory)
Emergency department visits and hospitalizations within 30 days. Exploratory.
Measured: Up to 30 days after the index encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start16 Jul 2026
- Primary completion19 Sep 2026
- Study completion17 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Health CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Waymark
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Sanjay Basu, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718893
- Sponsor's protocol ID
- CITE-2026-02
- Acronym
- CITE
- Status last verified
- Oct 2026
- First submitted
- 13 Jul 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07718893
- Acronym / sponsor ID
- CITE / CITE-2026-02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- WaymarkIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 19 Sep 2026 (actual)
- Study completion
- 17 Oct 2026 (actual)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Unassisted care | No intervention | –Clinician develops the care plan without AI assistance. |
| Arm 2: AI with safety guardrails | Active comparator | Other: AI care plan with safety guardrailsAI-generated care plan produced with a safety-guardrail system prompt; no CITE. |
| Arm 3: AI with safety guardrails plus CITE | Experimental | Other: CITE evidence-grounding retrieve-and-verify layer, Other: AI care plan with safety guardrailsAI-generated care plan with safety guardrails, then passed through CITE, which flags unsupported/inappropriate recommendations with evidence citations for the clinician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CITE evidence-grounding retrieve-and-verify layerReads 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. | Other | Arm 3: AI with safety guardrails plus CITE |
| AI care plan with safety guardrailsAI-generated care plan produced under a safety-guardrail system prompt. | Other | Arm 2: AI with safety guardrails, Arm 3: AI with safety guardrails plus CITE |
Primary outcome
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.
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.
6 secondary outcomes
Clinician action on CITE flags
Time frame: Day 1 (index primary care encounter)
Unresolved codifiable safety-hazard rate by arm (descriptive)
Time frame: Day 1 (index primary care encounter)
Correction of codifiable hazards within 30 days
Time frame: Up to 30 days after the index encounter
Completed referrals within 30 days
Time frame: Up to 30 days after the index encounter
Clinical safety composite (exploratory)
Time frame: Day 1 (index primary care encounter)
30-day acute care utilization (exploratory)
Time frame: Up to 30 days after the index encounter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CITE evidence-grounding retrieve-and-verify layer and AI care plan with safety guardrails in people with Quality of Health Care and Patient Safety, run by Waymark at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of CITE against clinician adjudication (time frame: Day 1 (index primary care encounter)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.