AI-guided deep vein thrombosis (DVT) diagnosis in primary care: protocol for cohort with qualitative assessment
| ISRCTN | ISRCTN14795960 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14795960 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 332800 |
| Protocol serial number | IRAS 332800, CPMS 58280 |
| Sponsor | Keele University |
| Funder | NHS Bristol, North Somerset And South Gloucestershire Integrated Care Board |
- Submission date
- 30/06/2024
- Registration date
- 04/07/2024
- Last edited
- 03/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
In this study, we aim to investigate a new approach with the overarching goal of enhancing the detection of deep vein thrombosis (DVT). DVT is a medical condition characterised by the formation of blood clots within the deep veins, most commonly occurring in the legs. The current standard for diagnosing DVT involves utilising the Wells Score, a scoring system, in conjunction with a blood test called D-dimer, followed by an ultrasound scan (USS) administered by specialised healthcare professionals (HCP).
However, this study explores the potential of a transformative technology that could change this paradigm. A scenario has been envisioned in which ordinary individuals, without specialised ultrasound (US) training, could employ a smartphone application (app) to perform a DVT scan of the leg. This innovative app serves as a comprehensive guide, leading users through the steps necessary to conduct a leg US examination.
The significance of this research becomes apparent when considering the potential implications. If successful, this approach has the capacity to revolutionise DVT diagnosis, enabling patients to receive prompt assessments in the convenience of their primary care provider's office or even within their own homes. Such a development could substantially expedite the diagnosis process, offering enhanced convenience to patients and potentially reducing the number of emergency department (ED) visits. Additionally, this innovation holds the promise of alleviating some of the financial strain on healthcare systems like the National Health Service (NHS) by optimising DVT diagnostic services. In essence, this study seeks to pave the way for a future in which DVT diagnosis becomes more accessible, efficient, and financially sustainable for HCPs.
Who can participate?
GP Care DVT Clinic eligible patients who have the capacity to consent can participate in this study.
What does the study involve?
During an appointment at the GP Care DVT clinic, patients who agree to participate will be consented and receive an additional ultrasound scan with the AI-guided handheld probe operated by the GP Care HCA. Participants are prompted to complete a participant satisfaction survey after the index and reference scan. A subgroup of 20 out of 562 participants will be invited for semi-structured interviews.
What are the possible benefits and risks of participating?
Benefit
- Participants may benefit from a quicker and more convenient assessment of their DVT risk.
- This method could reduce the need for immediate visits to specialised healthcare providers or emergency departments, saving time and potentially reducing healthcare costs.
- By participating, individuals contribute to research that could make DVT diagnosis more accessible and efficient in the future.
Risk
- As with any medical examination, there is a small risk of discomfort during the ultrasound scan.
- There is a potential risk that the app-guided scan might not be as accurate as a scan performed by a specialist, which could lead to either false reassurance or unnecessary concern. However, all app-guided scans will be reviewed by healthcare professionals to mitigate this risk.
Where is the study run from?
University of Bristol (UK)
When is the study starting and how long is it expected to run for?
May 2023 to May 2026
Who is funding the study?
NHS Bristol, North Somerset and South Gloucestershire Integrated Care Board (UK)
Who is the main contact?
kerstin.nothnagel@bristol.ac.uk
Alastair.Hay@bristol.ac.uk
michelle.spano@bristol.ac.uk
Contact information
Principal investigator
Canynge Hall
Clifton Bristol
Bristol
BS8 2PN
United Kingdom
 ORCID ID |
0009-0004-5767-8346 |
|---|---|
| Phone | +44 1174559936 |
| Kerstin.Nothnagel@bristol.ac.uk |
Scientific
Canynge Hall
Clifton Bristol
Bristol
BS8 2PN
United Kingdom
| ORCID ID |
0000-0002-4789-924X |
|---|---|
| Phone | +44 117 928 7279 |
| Alastair.Hay@bristol.ac.uk |
Public
Canynge Hall
Clifton Bristol
Bristol
BS8 2PN
United Kingdom
| ORCID ID |
0000-0001-7100-7099 |
|---|---|
| Phone | +44 117 928 7279 |
| michelle.spano@bristol.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Diagnostic cross-sectional study coupled with a qualitative evaluation |
| Secondary study design | Cross sectional study |
| Participant information sheet | 45715 Patient Information Sheet Quantitative 09.10.23.pdf |
| Scientific title | AI-guided point-of-care ultrasound for deep vein thrombosis diagnosis in primary care: protocol for a diagnostic accuracy and qualitative assessment study |
| Study acronym | AID-DVT |
| Study objectives | Current study objectives as of 03/09/2025: Primary Hypothesis: AI-guided point-of-care ultrasound (POCUS) performed by non-specialists in primary care settings is as accurate as traditional ultrasound scans (USS) conducted by sonographers for the diagnosis of deep vein thrombosis (DVT). Secondary Hypothesis: AI-guided POCUS for DVT diagnosis will be acceptable to patients and healthcare assistants (HCAs) in primary care settings, as measured by patient satisfaction surveys and semi-structured interviews. Qualitative objective: Explore the confidence and reservations of sonographers in providing remote diagnoses based on AI-guided, HCA-acquired ultrasound images. Previous study objectives: Primary Hypothesis: AI-guided point-of-care ultrasound (POCUS) performed by non-specialists in primary care settings is as accurate as traditional ultrasound scans (USS) conducted by sonographers for the diagnosis of deep vein thrombosis (DVT). Secondary Hypothesis: AI-guided POCUS for DVT diagnosis will be acceptable to patients and healthcare assistants (HCAs) in primary care settings, as measured by patient satisfaction surveys and semi-structured interviews. |
| Ethics approval(s) |
Approved 07/12/2023, London Bridge REC (2 Redman Place, Stratford, Stratford, E20 1JQ, United Kingdom; +44 2071048387; londonbridge.rec@hra.nhs.uk), ref: 23/PR/1242 |
| Health condition(s) or problem(s) studied | Deep vein thrombosis |
| Intervention | 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. This intervention is being compared to the traditional standard of care, which involves specialized ultrasound scans (USS) conducted by sonographers. 1. Enrolment: - Participants with suspected DVT are enrolled at primary care DVT clinics. 2. Diagnostic Test Accuracy (DTA) Study: - Participants undergo an AI-guided point-of-care ultrasound (POCUS) conducted by healthcare assistants (HCAs). - This is followed by a standard ultrasound scan (USS) performed by sonographers. 3. Patient Satisfaction Survey (PSS): - After completion of both the index (AI-guided POCUS) and reference (standard USS) scans, participants are prompted to complete a patient satisfaction survey. 4. Qualitative Semi-Structured Interviews: - A subgroup of the participants will be invited to participate in semi-structured interviews to explore the acceptability of AI-guided DVT diagnosis in primary care. - Semi-structured interviews with 4 HCAs as the operators of the AI-guided DVT diagnostic scan with handheld ultrasound probe (index scans). - Semi-structured interviews with 3 sonographers who would normally perform DVT diagnostic scans. Duration: - Participants in the DTA will be in the study for 20-30 minutes. - The subgroup of participants who agree to participate in semi-structured interviews will have their interviews within 1 to 3 weeks of participating in the DTA. - There is no additional follow-up required after the qualitative interviews. Previous interventions: AI-guided point-of-care ultrasound (POCUS) for the diagnosis of deep vein thrombosis (DVT) performed by healthcare assistants (HCAs) in primary care settings. This intervention is being compared to the traditional standard of care, which involves specialized ultrasound scans (USS) conducted by sonographers. 1. Enrolment: - Participants with suspected DVT are enrolled at primary care DVT clinics. 2. Diagnostic Test Accuracy (DTA) Study: - Participants undergo an AI-guided point-of-care ultrasound (POCUS) conducted by healthcare assistants (HCAs). - This is followed by a standard ultrasound scan (USS) performed by sonographers. 3. Patient Satisfaction Survey (PSS): - After completion of both the index (AI-guided POCUS) and reference (standard USS) scans, participants are prompted to complete a patient satisfaction survey. 4. Qualitative Semi-Structured Interviews: - A subgroup of the participants will be invited to participate in semi-structured interviews to explore the acceptability of AI-guided DVT diagnosis in primary care. Duration: - Participants in the DTA will be in the study for 20-30 minutes. - The subgroup of participants who agree to participate in semi-structured interviews will have their interviews within 1 to 3 weeks of participating in the DTA. - There is no additional follow-up required after the qualitative interviews. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Data collected during appointment: |
| Key secondary outcome measure(s) |
Data collected after participant received index and reference scan: |
| Completion date | 01/05/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 105 Years |
| Sex | All |
| Target sample size at registration | 500 |
| Total final enrolment | 562 |
| Key inclusion criteria | 1. Eligible for GP Care DVT Services †1 flowchart 2. Participant has capacity to consent to study participation |
| Key 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. |
| Date of first enrolment | 26/02/2023 |
| Date of final enrolment | 14/06/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Bristol
BS32 4TU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| IPD sharing plan | The dataset generated during the current study will be stored and available on the University of Bristol Data Repository. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 09/10/2023 | 04/07/2024 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 09/10/2023 | 04/07/2024 | No | No |
Additional files
- 45715 Patient Information Sheet Quantitative 09.10.23.pdf
- Participant information sheet
- 45715 Protocol 09.10.23.pdf
- Protocol file
Editorial Notes
03/09/2025: The following changes were made:
1. The University of Bristol (UK) replaced Keele University (UK) as where the study is run in the plain English summary.
2. The study objectives and interventions were amended.
02/08/2024: Internal review.
31/07/2024: Contact details corrected.
01/07/2024: Trial's existence confirmed by NHS HRA.
