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

Not Applicable

• Conditions: Peripheral Artery Disease; Peripheral Vascular Disease
• Interventions: Other: High PAD risk Alert

• Registration Number: NCT04054232
• Lead Sponsor: Stanford University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-09
• Study First Submitted QC: 2019-08-09
• Study First Posted: 2019-08-13
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-12
• Study Start: 2023-12
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EHR Alert	High PAD risk Alert	Twenty-five participants who are flagged by the screening tool as having high risk of undiagnosed peripheral artery disease (PAD) will be randomized to have their primary care physician receive an electronic health record message regarding their high risk of having PAD and a recommendation will be made to have the participant referred for non-invasive testing called Ankle Brachial Index (ABI) testing to confirm diagnosis. For individuals who undergo ABI testing and are confirmed to have PAD, they and their physicians will be provided with American Heart Association Guidelines for the management of PAD. Each participant's medical record will be reviewed for 6 months to evaluate for referral for ABI testing, referral to cardiovascular specialists (vascular medicine, vascular surgery or a cardiologist), and for initiation of new cardiovascular related medications such as an antiplatelet, statins, or anti-hypertensive medications.

Primary Outcome Measures

Name	Time	Method
New referral for ankle brachial index testing	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 Outcome Measures

Name	Time	Method
New PAD diagnosis	6 months after randomization	Number of patients newly diagnosed with peripheral artery disease in each arm 6 months after randomization.
New prescriptions for guideline-recommended medications	6 months after randomization	Number of new prescriptions given for antiplatelet agent, statin, and/or antihypertensive agents in each arm 6 months after randomization.
New referral to cardiovascular specialist	6 months after randomization	Number of new referrals to cardiovascular specialists (vascular medicine, vascular surgery and/or cardiology) in each arm 6 months after randomization.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States