Linus Health CDS Retrospective Validation Study

Retrospective Validation Study of Clinical Decision Support (CDS) Recommendations in the Linus Health Core Cognitive Evaluation

This study is a retrospective validation study of deidentified Clinical Decision Support (CDS) recommendations generated by the Linus Health Core Cognitive Evaluation (CCE) for patients who have completed the CCE.

Site investigators consist of clinical experts including neurologists and geriatricians in the U.S. After signing the study agreements, the experts will receive batches of anonymized CCE outputs of patients and will rate the appropriateness of each CDS recommendation for each patient based on their review of the CCE results and their clinical judgment and expertise. The experts will also rate the clinical appropriateness of various parts of CDS pathways that form the LH CDS decision tree.

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Impairment; Dementia; Motor Disorders
• Intervention / Treatment: Diagnostic test: Core Cognitive Evaluation (CCE)

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Ali Jannati, MD, PhD; Phone Number: 6174173002; Email: ajannati@linus.health
• Study Contact Backup: Name: William I Morrow, B.S.; Email: imorrow@linus.health

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02210
      • Linus Health, Inc.
      • Contact: Ali Jannati, MD, PhD; Phone Number: 617-417-3002; Email: ajannati@linus.health
      • Contact: William I Morrow; Email: imorrow@linus.health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 55 and above, with or without cognitive symptoms, across all the healthcare organizations that Linus Health has been deployed in.

Description

Inclusion Criteria:

• Age 55 and above
• Has already completed the Linus Health CCE

Exclusion Criteria:

• Incomplete CCEs
• CCEs that are flagged as "Requires clinician review"

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median rating of each CDS recommendation	Rating of clinical appropriateness on the scale of 1 (extremely inappropriate) to 9 (extremely appropriate) for each set of CDS recommendations generated by the Linus Health CCE.	2-3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraclass correlation coefficient (ICC) of each rating	ICC of each rating of clinical appropriateness to evaluate the inter-rater variability.	2-3 weeks

Collaborators and Investigators

• Sponsor: Linus Health, Inc.
• Investigators: Principal Investigator: Ali Jannati, MD, PhD, Linus Health

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): July 1, 2023
• Study Completion (Estimated): August 1, 2023

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Motor Disorders
• Other Study ID Numbers: CDSV-001

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No