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

NCT ID: NCT04054232

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2024-06-30

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).

Conditions

Peripheral Artery Disease; Peripheral Vascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

High PAD risk Alert

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Elsie Ross

Assistant Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elsie Ross, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Central Contacts

Elsie Ross, MD, MSc

Role: CONTACT

elsie.ross@stanford.edu

650-723-5477

Kate McGurk, BA

Role: CONTACT

kmcgurk@stanford.edu

650-723-2185

Facility Contacts

Elsie Ross, MD, MSc

Role: primary

elsie.ross@stanford.edu

650-723-5477

Other Identifiers

1K01HL148639

Identifier Type: NIH

Identifier Source: secondary_id

View Link

52645

Identifier Type: -

Identifier Source: org_study_id