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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Vascular Disease; Peripheral Artery Disease
• Intervention / Treatment: Other: High PAD risk Alert

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elsie Ross, MD, MSc; Phone Number: 650-723-5477; Email: elsie.ross@stanford.edu
• Study Contact Backup: Name: Kate McGurk, BA; Phone Number: 650-723-2185; Email: kmcgurk@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University
      • Contact: Elsie Ross, MD, MSc; Phone Number: 650-723-5477; Email: elsie.ross@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: EHR 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.	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.
NO_INTERVENTION: No EHR 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
New PAD diagnosis	Number of patients newly diagnosed with peripheral artery disease in each arm 6 months after randomization.	6 months after randomization
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
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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Elsie Ross, MD, MSc, Stanford University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2023
• Primary Completion (ANTICIPATED): June 1, 2024
• Study Completion (ANTICIPATED): June 1, 2024

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (ACTUAL): August 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 52645; 1K01HL148639 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No