Artificial Intelligence for Early Detection of Peripheral Artery Disease

Not Applicable

Not yet recruiting

• Conditions: Peripheral Arterial Disease
• Interventions: Diagnostic Test: AI-based PAD screening intervention

• Registration Number: NCT06505317
• Lead Sponsor: University of California, San Diego

Brief Summary

The goal of this clinical trial is to test an AI-based screening tool that will help to identify patients at high risk of having undiagnosed peripheral artery disease. The primary outcome measure is overall rate of new PAD diagnoses. Secondary outcomes include rate of new secondary prevention measures initiated for PAD, which will include new prescriptions for antiplatelets, PAD-dosed rivaroxaban, statins, smoking cessation counseling or referrals, and/or supervised exercise therapy referrals also aggregated at a clinic and site level.

Detailed Description

After providers consent to participate in this study, a screening tool will be deployed for their weekly clinics to identify patients at high risk of having undiagnosed PAD. These high risk alerts will be provided after a patient has checked in for their outpatient appointment. The alert will be sent to their treating provider once the visit is initiated in the electronic health record system (EHR). The primary outcome measure is overall rate of new PAD diagnoses. Secondary outcomes include rate of new secondary prevention measures initiated for PAD, which will include new prescriptions for antiplatelets, PAD-dosed rivaroxaban, statins, smoking cessation counseling or referrals, and/or supervised exercise therapy referrals also aggregated at a clinic and site level. For secondary analysis we will specifically evaluate patients who generated an alert and assess how patient demographics and/or clinical factors are associated with likelihood of ABI testing, rate of abnormal ABIs (i.e. true positive rate), and subsequent initiation of secondary prevention measures.

UC San Diego Health (UCSDH), VA San Diego Health Care (VASDHC), and Stanford Health Care (SHC) will be the sites for study enrollment. UCSDH - La Jolla campus, UCSDH - Hillcrest campus, and VASDHC will begin a pre-intervention observation period at the same time, and then each site will be randomized to begin screening tool intervention in a stepped wedge pattern at 13-week intervals for a total of 52 weeks. We will enroll 10 clinics per site based on power calculations for number of patients needed to screen each week and to minimize the number of alerts per clinic/ provider. After this 52 week period, the Stanford site will serve as a validation site and will undergo randomization of 10 clinical sites to three 13 week intervals for a total of 52 weeks.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-10
• Last Update Submitted: 2024-07-10
• Study First Posted: 2024-07-17
• Last Update Posted: 2024-07-17
• Study Start: 2026-07-01
• Primary Completion: 2027-07-01
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 7800

Inclusion Criteria

• Aged 50-85 years
• Presenting to an outpatient appointment at UCSDH, SDVA, or SHC
• No previous diagnosis of PAD
• No prior PAD alert triggered for a previous visit

Exclusion Criteria

• <50 years of age or > 85 years of age
• Prior diagnosis of PAD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Clinical Site 3	AI-based PAD screening intervention	Randomized to start AI-based PAD screening intervention at Week 39.
Clinical Site 1	AI-based PAD screening intervention	Randomized to start AI-based PAD screening interventionat week 13.
Clinical Site 2	AI-based PAD screening intervention	Randomized to start AI-based PAD screening intervention at Week 26.

Primary Outcome Measures

Name	Time	Method
PAD Diagnosis Rate	During 13-39 weeks prior to intervention compared to 13-39 weeks during intervention depending on timing of randomization to intervention period.	The primary outcome will be counted at a clinic and site level and will include number of new abnormal ABI tests (ABI\< 0.9), and new diagnosis codes, procedures or affirmative text mentions for PAD for patients without a previous diagnosis

Secondary Outcome Measures

Name	Time	Method
Initiation of secondary prevention measures	During 13-39 weeks prior to intervention compared to 13-39 weeks during intervention depending on timing of randomization to intervention period.	New prescriptions for antiplatelets, PAD-dosed rivaroxaban, statins, smoking cessation counseling or referrals, and/or supervised exercise therapy referrals also aggregated at a clinic and site level time period.