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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Marc S Lener, MD
- Número de teléfono: (240) 389-2381
- Correo electrónico: marc.lener@singulahealth.com
Ubicaciones de estudio
-
-
New York
-
Brentwood, New York, Estados Unidos, 11717
- Terminado
- Morris Medical Office
-
Mount Kisco, New York, Estados Unidos, 10549
- Reclutamiento
- WestDocs Concierge
-
Contacto:
- Lisa Youkeles, MD
- Número de teléfono: 914-218-3838
- Correo electrónico: general@westdocsconcierge.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Successful Production and Delivery of the Companion Brief
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Survey 0.1 Completion Rate
Periodo de tiempo: Up to 7 days
|
Completion rate of Survey 0.1 among consented patient participants |
Up to 7 days
|
|
Pipeline End-to-End Latency
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Up to 7 days
|
Patient-side dropout and question-skipping patterns during completion of Survey 0.1. |
Up to 7 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marc S Lener, MD, Singula Health, Inc.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SINGULA-CDSS-PCP-0.1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .