NCT04054232

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Peripheral Artery Disease
• Peripheral Vascular Disease

Interventions

Type	Name	Description
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: 1. Participant flagged as having a high risk of peripheral artery disease based on their electronic health record data 2. What peripheral artery disease is and why diagnosis may be important 3. Recommendation to refer to a vascular medicine specialist or order ankle brachial index for definitive diagnosis 4. 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.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2019-08-13
• Last updated: 2022-07-12

Locations

1 site across 1 country: United States