A Randomized Controlled Trial to Evaluate an EHR-based PAD Screening Tool
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Peripheral Artery Disease
- Sponsor
- Stanford University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- New referral for ankle brachial index testing
- Last Updated
- 3 years ago
Overview
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).
Investigators
Elsie Ross
Assistant Professor of Surgery
Stanford University
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.
Outcomes
Primary Outcomes
New referral for ankle brachial index testing
Time Frame: 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 Outcomes
- New PAD diagnosis(6 months after randomization)
- New prescriptions for guideline-recommended medications(6 months after randomization)
- New referral to cardiovascular specialist(6 months after randomization)