Singula Phase 0.1 Primary Care Pilot
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSingula Health, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Primary Care Patient Cohort
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 7 days2
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 daysSecondary outcomes
1
Survey 0.1 Completion Rate
Completion rate of Survey 0.1 among consented patient participants
Time frame
Up to 7 days2
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 hours3
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 days4
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 daysSponsors and contacts
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Source ClinicalTrials.gov