Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505317
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Artificial Intelligence for Early Detection of Peripheral Artery Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Artificial Intelligence for Early Detection of Peripheral Artery Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AID-PAD
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 andor 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 andor 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 andor clinical factors are associated with likelihood of ABI testing rate of abnormal ABIs ie 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None