Peripheral Artery Disease Clinical Trial
Official title:
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).
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | New PAD diagnosis | Number of patients newly diagnosed with peripheral artery disease in each arm 6 months after randomization. | 6 months after randomization | |
Secondary | 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 | |
Secondary | 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 |
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