Singula Phase 0.1 Primary Care Pilot
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Marc S Lener, MD
- Telefonnummer: (240) 389-2381
- E-mail: marc.lener@singulahealth.com
Studiesteder
-
-
New York
-
Brentwood, New York, Forenede Stater, 11717
- Afsluttet
- Morris Medical Office
-
Mount Kisco, New York, Forenede Stater, 10549
- Rekruttering
- WestDocs Concierge
-
Kontakt:
- Lisa Youkeles, MD
- Telefonnummer: 914-218-3838
- E-mail: general@westdocsconcierge.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Successful Production and Delivery of the Companion Brief
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Survey 0.1 Completion Rate
Tidsramme: Up to 7 days
|
Completion rate of Survey 0.1 among consented patient participants |
Up to 7 days
|
|
Pipeline End-to-End Latency
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 7 days
|
Patient-side dropout and question-skipping patterns during completion of Survey 0.1. |
Up to 7 days
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Marc S Lener, MD, Singula Health, Inc.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SINGULA-CDSS-PCP-0.1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .