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Singula Phase 0.1 Primary Care Pilot

16 september 2026 bijgewerkt door: Singula Health, Inc.

Validation of an Artificial Intelligence (AI)-Powered Clinical Decision Support System for Anxiety and Depression in Primary Care Settings

This prospective, single-arm, observational pilot study evaluates a clinical decision support system developed by Singula Health for use in primary care. Adult patients complete a self-report assessment before a routine primary care visit. The system uses the responses to generate a clinician-facing Companion Brief that summarizes relevant information for the treating clinician. Each Companion Brief is reviewed by the Principal Investigator before it is provided to the clinician. The study will evaluate whether the system can reliably generate and deliver the Companion Briefs, whether clinicians find the Briefs useful and acceptable, and whether patients can successfully complete and accept the pre-visit assessment.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

The Singula clinical decision support system is designed to organize information collected from a patient before a routine primary care visit into a structured Companion Brief for the treating clinician. The pre-visit assessment includes validated screening measures and structured questions addressing behavioral health symptoms and other factors relevant to the patient's clinical context. After a patient completes the assessment, an automated software pipeline processes the responses and generates a draft Companion Brief. The Principal Investigator reviews each Artificial Intelligence (AI)-generated Brief for clinical accuracy, appropriate safety language, and potential errors before it is released to the treating clinician. The treating clinician receives the reviewed Brief before the patient's routine primary care visit and retains full independent authority over clinical assessment and decision-making. The Companion Brief is informational and does not direct treatment. This Phase 0.1 pilot is intended primarily to characterize the feasibility and operational performance of this workflow in real-world primary care. The study will examine successful generation and delivery of Companion Briefs, pipeline performance, clinician feedback regarding the utility and acceptability of the Briefs, patient completion of the pre-visit assessment, and errors or other operational issues identified during the pilot. Findings from this study are intended to inform subsequent technical, operational, and clinical development of the system.

Studietype

Observationeel

Inschrijving (Geschat)

100

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • New York
      • Brentwood, New York, Verenigde Staten, 11717
        • Voltooid
        • Morris Medical Office
      • Mount Kisco, New York, Verenigde Staten, 10549

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

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Adults aged 18 years or older presenting for a routine, non-urgent primary care visit at a participating independent primary care practice. Eligible patients complete a pre-visit electronic informed consent and self-report assessment (Survey 0.1) on a personal device prior to their scheduled visit.

Beschrijving

Inclusion Criteria:

  • Adult, aged 18 years or older at the time of consent.
  • Scheduled for a routine, non-urgent primary care visit at a participating practice.
  • Able to read and understand English at a level sufficient to complete the electronic informed consent and Survey 0.1 independently.
  • Has personal-device access to complete the survey (smartphone, tablet, or computer with internet).
  • Capable of providing informed consent.

Exclusion Criteria:

  • Non-English-speaking, defined as inability to read English at a level sufficient to complete electronic informed consent and the survey independently.
  • Visually impaired to a degree that prevents independent reading of an electronic consent form on a personal device, without specialized assistive technology beyond standard mobile-device accessibility features.
  • Unable to read for any reason (literacy, cognitive impairment, or other).
  • Presenting with an acute psychiatric emergency or in acute crisis at the time of the scheduled visit, as identified by clinic staff during routine check-in.
  • Patient is a known minor at the time of scheduling (under 18 years).
  • Patient or clinician declines participation.

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

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Primary Care Patient Cohort

Adult primary care patients evaluated during routine clinical care using the Singula Artificial Intelligence (AI)-powered clinical decision support system for assessment of anxiety and depression. Participants are included in a single observational cohort; no study-assigned intervention is administered.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Successful Production and Delivery of the Companion Brief
Tijdsspanne: Up to 7 days

Proportion of enrolled patient cases for which an Artificial Intelligence (AI)-generated Companion Brief is successfully produced, reviewed by the Principal Investigator, and delivered to the treating clinician prior to the patient's scheduled visit.
Up to 7 days
Clinician-Rated Overall Clinical Utility of the Companion Brief
Tijdsspanne: Periodic feedback during active enrollment, approximately 30 to 90 days

Clinician-rated overall clinical utility of the Companion Brief, captured on the periodic batched feedback survey using a 5-point Likert scale. Target: ≥70% of feedback batches indicating overall utility of "useful" or "very useful" across the cases covered in each batch.
Periodic feedback during active enrollment, approximately 30 to 90 days

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Survey 0.1 Completion Rate
Tijdsspanne: Up to 7 days

Completion rate of Survey 0.1 among consented patient participants
Up to 7 days
Pipeline End-to-End Latency
Tijdsspanne: Up to 72 hours

End-to-end latency from Survey 0.1 submission to availability of the generated Companion Brief in storage.
Up to 72 hours
Principal Investigator Corrections to Large Language Model (LLM)-Generated Reports
Tijdsspanne: Up to 7 days

Number and category of Principal Investigator corrections to Large Language Model (LLM)-Generated Companion Briefs, categorized as clinical accuracy, safety language, formatting, or hallucination.
Up to 7 days
Number of Safety-Flag Triggers Generated by the Clinical Decision Support System
Tijdsspanne: Up to 8 days

Total number of safety-flag triggers generated by the clinical decision support system during the study period. Safety-flag triggers will be classified by risk level (Critical or High) for descriptive reporting.
Up to 8 days
Number of Safety-Flag Triggers by Documented Disposition
Tijdsspanne: Up to 8 days

Number of safety-flag triggers by documented disposition category following Principal Investigator review and clinician notification.
Up to 8 days
Clinician-Rated Most Useful Companion Brief Section
Tijdsspanne: Periodic feedback during active enrollment, approximately 30 to 90 days

Clinician identification of the most useful Companion Brief section across cases included in each feedback batch.
Periodic feedback during active enrollment, approximately 30 to 90 days
Number of Feedback Batches With Clinician-Reported Influence on Clinical Decision-Making, Measured by the Singula Clinician Feedback Survey
Tijdsspanne: Periodic feedback during active enrollment, approximately 30 to 90 days

Clinician-reported influence of Companion Briefs on clinical decision-making will be assessed using the Singula Clinician Feedback Survey. For each feedback batch, clinicians will indicate whether any Companion Brief in the batch period influenced a clinical decision. The outcome will be reported as the number of feedback batches in which an influence on clinical decision-making was reported.
Periodic feedback during active enrollment, approximately 30 to 90 days
Clinician-Reported Willingness to Continue Using the Companion Brief, Measured by the Singula Clinician Feedback Survey
Tijdsspanne: Periodic feedback during active enrollment, approximately 30 to 90 days

Clinician-reported willingness to continue using the Companion Brief system will be assessed using the Singula Clinician Feedback Survey. Responses will be summarized across clinician feedback collected during the study period.
Periodic feedback during active enrollment, approximately 30 to 90 days
Patient Survey Dropout and Skip Patterns
Tijdsspanne: Up to 7 days

Patient-side dropout and question-skipping patterns during completion of Survey 0.1.
Up to 7 days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Singula Health, Inc.

Onderzoekers

  • Hoofdonderzoeker: Marc S Lener, MD, Singula Health, Inc.

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 (Werkelijk)

13 juli 2026

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 januari 2027

Studieregistratiedata

Eerst ingediend

4 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

16 september 2026

Eerst geplaatst (Werkelijk)

22 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 september 2026

Laatste update ingediend die voldeed aan QC-criteria

16 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SINGULA-CDSS-PCP-0.1

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared with other researchers. External use of study findings will be limited to aggregate, de-identified data. Individual participant data, individual Companion Briefs, and individual survey responses will not be used externally. De-identified analytic data may be retained by Singula Health, Inc. for internal product development, regulatory documentation, and internal research and quality improvement.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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