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Singula Phase 0.1 Primary Care Pilot

2026年9月16日更新者：Singula Health, Inc.

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.

研究概览

地位

招聘中

条件

详细说明

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.

研究类型

观察性的

注册 (估计的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Marc S Lener, MD
电话号码：(240) 389-2381
邮箱：marc.lener@singulahealth.com

学习地点

美国
- New York
  - Brentwood、New York、美国、11717
    - 完全的
    - Morris Medical Office
  - Mount Kisco、New York、美国、10549
    - 招聘中
    - WestDocs Concierge
    - 接触：
      
      Lisa Youkeles, MD
      
      电话号码：914-218-3838
      
      邮箱：general@westdocsconcierge.com

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：COHORT
时间观点：PROSPECTIVE

团体/队列数

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Successful Production and Delivery of the Companion Brief 大体时间：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 大体时间：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

次要结果测量

结果测量	措施说明	大体时间
Survey 0.1 Completion Rate 大体时间：Up to 7 days	Completion rate of Survey 0.1 among consented patient participants	Up to 7 days
Pipeline End-to-End Latency 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：Up to 7 days	Patient-side dropout and question-skipping patterns during completion of Survey 0.1.	Up to 7 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Singula Health, Inc.

调查人员

首席研究员：Marc S Lener, MD、Singula Health, Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月13日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2027年1月1日

研究注册日期

首次提交

2026年9月4日

首先提交符合 QC 标准的

2026年9月16日

首次发布 (实际的)

2026年9月22日

研究记录更新

最后更新发布 (实际的)