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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04054232
Other study ID # 52645
Secondary ID 1K01HL148639
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2023
Est. completion date June 2024

Study information

Verified date July 2022
Source Stanford University
Contact Elsie Ross, MD, MSc
Phone 650-723-5477
Email elsie.ross@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

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.

Study Design


Intervention

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.

Locations

Country Name City State
United States Stanford University Palo Alto California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

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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