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

Stanford University

Status: Not yet enrolling

Conditions: Peripheral Vascular Disease; Peripheral Artery Disease

Treatments: Other: High PAD risk Alert

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04054232

52645

1K01HL148639 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

EHR Alert

Experimental group

Description:

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.

Treatment:

Other: High PAD risk Alert

No EHR Alert

No Intervention group

Description:

Twenty-five participants who are flagged by the screening tool as having high risk of undiagnosed peripheral artery disease (PAD) will be randomized to the control arm and they nor their physicians will be alerted of their status for 6 months. 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. At the end of 6 months of observation, the primary care physician's of control participants will receive the same alert as participants in the intervention arm.