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NCT Number: NCT06505317

Artificial Intelligence for Early Detection of Peripheral Artery Disease

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AI-based PAD screening intervention

Diagnostic Test

Providers will receive alerts for a patient that is flagged by model as being "high risk" for PAD. This will allow the provider to review the alert, check the patient's previous history, develop additional questions to assess the risk of PAD, and initiate orders prior to seeing a patient. Depending on their assessment during the patient visit the provider may choose to order an ABI test (or perform one at bedside) and/or initiate other secondary prevention measures. All patients for which an alert is triggered will be included for secondary analysis.

Primary outcomes

  1. PAD Diagnosis Rate

    Time frame: 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 outcomes

  1. Initiation of secondary prevention measures

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathleen Groh

CONTACT

[email protected]

8585348103

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute on Aging (NIA)
  • Stanford University

Registry information

Acronym: (AID-PAD)

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 17, 2024
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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