AI-guided deep vein thrombosis (DVT) diagnosis in primary care: protocol for cohort with qualitative assessment

AI-guided point-of-care ultrasound for deep vein thrombosis diagnosis in primary care: protocol for a diagnostic accuracy and qualitative assessment study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN14795960

Enrollment

500

Registered

2024-07-04

Start date

2023-02-26

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep vein thrombosis Circulatory System

Interventions

Current interventions as of 03/09/2025: AI-guided point-of-care ultrasound (POCUS) for the diagnosis of deep vein thrombosis (DVT) performed by healthcare assistants (HCAs) in primary care settings. T

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Eligible for GP Care DVT Services †1 flowchart 2. Participant has capacity to consent to study participation

Exclusion criteria

Exclusion criteria: 1. Unable to communicate in English (spoken or written) and there is no translator available. 2. For the qualitative study, patients who have a hearing impairment that would hinder the feasibility of an e-interview.

Design outcomes

Primary

Measure	Time frame
Data collected during appointment: 1. Accuracy of HCA-reported AI-guided DVT diagnosis. Data Collected: Diagnosis of proximal DVT (yes/no). Method of Measurement: Comparison with reference standard of sonographer scan 2. Accuracy of AI-provided DVT diagnosis. Data Collected: Diagnosis of proximal DVT (yes/no). Method of Measurement: Comparison with reference standard of sonographer scan 3. Accuracy of remote specialist diagnosis using AI-guided acquired ultrasound images. Data Collected: Diagnosis of proximal DVT (yes/no). Method of Measurement: Comparison with reference standard of sonographer scan	—

Measure

Time frame

Data collected during appointment: 1. Accuracy of HCA-reported AI-guided DVT diagnosis. Data Collected: Diagnosis of proximal DVT (yes/no). Method of Measurement: Comparison with reference standard of sonographer scan 2. Accuracy of AI-provided DVT diagnosis. Data Collected: Diagnosis of proximal DVT (yes/no). Method of Measurement: Comparison with reference standard of sonographer scan 3. Accuracy of remote specialist diagnosis using AI-guided acquired ultrasound images. Data Collected: Diagnosis of proximal DVT (yes/no). Method of Measurement: Comparison with reference standard of sonographer scan

—

Secondary

Measure	Time frame
Data collected after participant received index and reference scan: 1. Proportion of HCA-acquired images of adequate quality for renovate diagnosis. Data Collected image quality (adequate/inadequate according to ACEPO Score). Method of Measurement: Evaluation by 5 independent specialist (sonographer/ radiographer 2. Factors associated with inadequate image quality. Data Collected: Factors such as HCA experience, patient BMI, and machine settings. Method of Measurement: collected by CRN staff during patient recruitment at GPCare DVT Clinic 3. Patient satisfaction with AI-guided DVT diagnosis. Data Collected: Satisfaction score. Method of Measurement: Patient Satisfaction Survey Qualitative Objectives: 1. Explore patient reservations, obstacles, and confidence in relation to AI-guided point-of-care US undertaking as a diagnostic scan for DVT 2. Explore the confidence of HCAs in the index scan 3. Explore the experience of HCAs in delivering the scan Data Collected: Patient interviews, including demographic information (gender, age, postcode) Method of Measurement Semi-structured interviews Time-point 1-3 weeks post-scan	—

Measure

Time frame

Data collected after participant received index and reference scan: 1. Proportion of HCA-acquired images of adequate quality for renovate diagnosis. Data Collected image quality (adequate/inadequate according to ACEPO Score). Method of Measurement: Evaluation by 5 independent specialist (sonographer/ radiographer 2. Factors associated with inadequate image quality. Data Collected: Factors such as HCA experience, patient BMI, and machine settings. Method of Measurement: collected by CRN staff during patient recruitment at GPCare DVT Clinic 3. Patient satisfaction with AI-guided DVT diagnosis. Data Collected: Satisfaction score. Method of Measurement: Patient Satisfaction Survey Qualitative Objectives: 1. Explore patient reservations, obstacles, and confidence in relation to AI-guided point-of-care US undertaking as a diagnostic scan for DVT 2. Explore the confidence of HCAs in the index scan 3. Explore the experience of HCAs in delivering the scan Data Collected: Patient interviews, including demographic information (gender, age, postcode) Method of Measurement Semi-structured interviews Time-point 1-3 weeks post-scan

—

Countries

England, United Kingdom

Contacts

Public ContactMichelle Spano

michelle.spano@bristol.ac.uk+44 117 928 7279

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026