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Clinical Trials/NCT04054232
NCT04054232
Unknown
N/A

A Randomized Controlled Trial to Evaluate an EHR-based PAD Screening Tool

Stanford University1 site in 1 country50 target enrollmentDecember 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Peripheral Artery Disease
Sponsor
Stanford University
Enrollment
50
Locations
1
Primary Endpoint
New referral for ankle brachial index testing
Last Updated
3 years ago

Overview

Brief Summary

This protocol represents a pilot randomized-controlled trial evaluating the effect of an electronic health record (EHR)-based peripheral artery disease (PAD) screening tool on rates of new non-invasive testing, diagnosis and treatment of PAD over a 6-month period. An EHR-based PAD screening tool will be applied to the Stanford EHR, which will generate a group of patients of varying risks of having undiagnosed PAD. Patients with the highest risk of having undiagnosed PAD will then be evaluated for inclusion in this study. 1:1 randomization will be performed on a consecutive basis until study enrollment is completed (25 patients per arm).

Physicians of patients randomized to the intervention arm will be sent notification via an EHR message detailing the patient's risk of undiagnosed PAD and suggestions for referral to vascular medicine for risk assessment and/or non-invasive ankle brachial index (ABI) testing. The primary outcome is number of patients receiving ABI testing for PAD at 6 months, with secondary outcomes including number of new PAD diagnoses, number of new referrals to cardiovascular specialists (vascular medicine, vascular surgery, and/or cardiology) and number of patients receiving initiation of new cardiovascular medications (anti-platelet agents, statins, and/or antihypertensive agents).

Registry
clinicaltrials.gov
Start Date
December 2023
End Date
June 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elsie Ross

Assistant Professor of Surgery

Stanford University

Eligibility Criteria

Inclusion Criteria

  • Are 50-85 years old
  • Currently an outpatient, actively obtaining care at Stanford
  • Have at least 1 year of data within the Stanford EHR (including at least 2 clinical visits)
  • Have no prior diagnosis of peripheral artery disease as determined by no chart term mentions or ICD-9/10 codes in their EHR data

Exclusion Criteria

  • Have less than 1 year of data available or less than 2 clinical visits at Stanford
  • Enrolled in a previous related study
  • Receiving treatment for a potentially terminal condition
  • Prior diagnosis of peripheral artery disease by ICD code or term mention in their EHR data.

Outcomes

Primary Outcomes

New referral for ankle brachial index testing

Time Frame: 6 months after randomization

Number of new orders/referrals to obtain non-invasive diagnosis of peripheral artery disease with ankle-brachial index in each arm 6 months after randomization.

Secondary Outcomes

  • New PAD diagnosis(6 months after randomization)
  • New prescriptions for guideline-recommended medications(6 months after randomization)
  • New referral to cardiovascular specialist(6 months after randomization)

Study Sites (1)

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