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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Depression - Major Depressive Disorder

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Marc S Lener, MD; Phone Number: (240) 389-2381; Email: marc.lener@singulahealth.com

Study Locations

• United States
  • New York
    • Brentwood, New York, United States, 11717
      • Completed
      • Morris Medical Office
    • Mount Kisco, New York, United States, 10549
      • Recruiting
      • WestDocs Concierge
      • Contact: Lisa Youkeles, MD; Phone Number: 914-218-3838; Email: general@westdocsconcierge.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: PROSPECTIVE

Number of groups / cohorts

1

Cohorts and Interventions

Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Production and Delivery of the Companion Brief	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survey 0.1 Completion Rate	Completion rate of Survey 0.1 among consented patient participants	Up to 7 days
Pipeline End-to-End Latency	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	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	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	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	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	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	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	Patient-side dropout and question-skipping patterns during completion of Survey 0.1.	Up to 7 days

Collaborators and Investigators

• Sponsor: Singula Health, Inc.
• Investigators: Principal Investigator: Marc S Lener, MD, Singula Health, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: September 4, 2026
• First Submitted That Met QC Criteria: September 16, 2026
• First Posted (Actual): September 22, 2026

Study Record Updates

• Last Update Posted (Actual): September 22, 2026
• Last Update Submitted That Met QC Criteria: September 16, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Primary Care; Artificial Intelligence; Clinical Decision Support System; Mental Health Screening; Patient Health Questionnaire-9 (PHQ-9); Companion Brief; Generalized Anxiety Disorder-7 (GAD-7)
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: SINGULA-CDSS-PCP-0.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No