Artificial Intelligence for Early Detection of Peripheral Artery Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI-based PAD screening intervention.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test AI-based PAD screening intervention
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 ale
Primary outcome measures
- 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.]
Secondary outcome measures (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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Ghanzouri I, Amal S, Ho V, Safarnejad L, Cabot J, Brown-Johnson CG, Leeper N, Asch S, Shah NH, Ross EG. Performance and usability testing of an automated tool for detection of peripheral artery disease using electronic health records. Sci Rep. 2022 Aug 3;12(1):13364. doi: 10.1038/s41598-022-17180-5. PMID 35922657
Identifiers
NCT: NCT06505317 · (AID-PAD) · R01AG084343-01