Peripheral Artery DiseaseNCT04054232
Evaluation of an Electronic Health Record-based Screening Tool for Peripheral Artery Disease
A study testing High PAD risk Alert in people with Peripheral Artery Disease and Peripheral Vascular Disease, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Peripheral Artery Disease, Peripheral Vascular Disease
- What is being tested?
- High PAD risk Alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University
Palo Alto, California, 94305
Elsie Ross, MD, MSc, 650-723-5477, elsie.ross@stanford.edu
About this study
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).
- Being tested
- High PAD risk Alert
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High PAD risk AlertOther
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.
| Study group | Role | What they receive |
|---|---|---|
| EHR Alert | Experimental | 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. Receives: Other: High PAD risk Alert |
| No EHR Alert | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after randomization
Secondary outcomes (3)
New PAD diagnosis
Number of patients newly diagnosed with peripheral artery disease in each arm 6 months after randomization.
Measured: 6 months after randomization
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.
Measured: 6 months after randomization
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.
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study startDec 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Elsie Ross, Stanford University
- Investigators
- Elsie Ross, MD, MSc, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054232
- Sponsor's protocol ID
- 52645
- Other IDs
- 1K01HL148639
- Status last verified
- Jul 2022
- First submitted
- 9 Aug 2019
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate an EHR-based PAD Screening Tool
- ClinicalTrials.gov ID
- NCT04054232
- Acronym / sponsor ID
- 52645
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| EHR Alert | Experimental | Other: High PAD risk AlertTwenty-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. |
| No EHR Alert | No intervention | –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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High PAD risk AlertIn 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. | Other | EHR Alert |
Primary outcome
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.
3 secondary outcomes
New PAD diagnosis
Time frame: 6 months after randomization
New referral to cardiovascular specialist
Time frame: 6 months after randomization
New prescriptions for guideline-recommended medications
Time frame: 6 months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elsie Ross, MD, MSc principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High PAD risk Alert in people with Peripheral Artery Disease and Peripheral Vascular Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elsie Ross, MD, MSc (650-723-5477, elsie.ross@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New referral for ankle brachial index testing (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.