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.
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
100
Morris Medical Office
Brentwood, New York, United States
COMPLETEDWestDocs Concierge
Mount Kisco, New York, United States
RECRUITINGSuccessful 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.
Time frame: 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.
Time frame: Periodic feedback during active enrollment, approximately 30 to 90 days
Survey 0.1 Completion Rate
Completion rate of Survey 0.1 among consented patient participants
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 7 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.