Evaluation of an Electronic Health Record-based Screening Tool for Peripheral Artery Disease

Peripheral Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04054232
• Other study ID #: 52645
• Secondary ID: 1K01HL148639
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: June 2024

Study information

• Verified date: July 2022
• Source: Stanford University
• Contact: Elsie Ross, MD, MSc
• Phone: 650-723-5477
• Email: elsie.ross[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Other:
• High PAD risk Alert
In this message sent via the electronic health record, a participant's primary care physician will receive a message that details the following: Participant flagged as having a high risk of peripheral artery disease based on their electronic health record data What peripheral artery disease is and why diagnosis may be important Recommendation to refer to a vascular medicine specialist or order ankle brachial index for definitive diagnosis The option to opt out if the potential participant is not deemed a candidate for inclusion in the study with a short explanation of why the potential participant should not be included.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New referral for ankle brachial index testing	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.	6 months after randomization
Secondary	New PAD diagnosis	Number of patients newly diagnosed with peripheral artery disease in each arm 6 months after randomization.	6 months after randomization
Secondary	New referral to cardiovascular specialist	Number of new referrals to cardiovascular specialists (vascular medicine, vascular surgery and/or cardiology) in each arm 6 months after randomization.	6 months after randomization
Secondary	New prescriptions for guideline-recommended medications	Number of new prescriptions given for antiplatelet agent, statin, and/or antihypertensive agents in each arm 6 months after randomization.	6 months after randomization