Clinical trial NCT04054232: Evaluation of an Electronic Health Record-based Screening Tool for Peripheral Artery Disease
Official title: A Randomized Controlled Trial to Evaluate an EHR-based PAD Screening Tool
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Artery Disease
Peripheral Vascular Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-08-13
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with a high risk of having undiagnosed PAD will be identified using an EHR-based PAD screening tool. Fifty total patients meeting inclusion criteria will be randomized to either the intervention arm - primary treating physician notified about high risk of undiagnosed PAD - or the control arm - no notification provided. Physician notification will include suggestions to refer the patient to vascular medicine and/or order ankle brachial index (ABI) testing. If a patient is found to have PAD diagnosed by ABI the patient and provider will be notified and provided guidelines from the American Heart Association regarding management of PAD.
Primary purpose: SCREENING

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).


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.

Primary outcomes:
measure: New referral for ankle brachial index testing
timeFrame: 6 months after randomization
Secondary outcomes:
measure: New PAD diagnosis
timeFrame: 6 months after randomization
measure: New referral to cardiovascular specialist
timeFrame: 6 months after randomization
measure: New prescriptions for guideline-recommended medications
timeFrame: 6 months after randomization
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Elsie Ross, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: