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EHR-Based PAD Screening for Peripheral Arterial Disease

N/A

Waitlist Available

Led By Elsie Ross, MD, MSc

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have no prior diagnosis of peripheral artery disease as determined by no chart term mentions or ICD-9/10 codes in their EHR data

Are 50-85 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after randomization

Awards & highlights

Study Summary

This trial is testing whether an electronic health record (EHR)-based peripheral artery disease (PAD) screening tool can improve rates of new non-invasive testing, diagnosis and treatment of PAD over a 6-month period.

Who is the study for?

This trial is for outpatients aged 50-85 actively receiving care at Stanford with at least one year of data and two clinical visits in their EHR, but no prior diagnosis of peripheral artery disease. Those with less than a year's data, fewer visits, participation in related studies, terminal conditions or previous PAD diagnoses are excluded.Check my eligibility

What is being tested?

The study tests an electronic health record-based tool that alerts doctors to patients at high risk for undiagnosed Peripheral Artery Disease (PAD). It aims to see if this leads to more testing, diagnoses, specialist referrals and treatment starts over six months compared to usual care without the alert.See study design

What are the potential side effects?

Since the intervention involves only an electronic alert system for physicians rather than direct patient treatments or medications, there are no direct side effects from the intervention itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never been diagnosed with peripheral artery disease.

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I am between 50 and 85 years old.

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I have been a patient at Stanford for over a year with at least 2 visits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

New referral for ankle brachial index testing

Secondary outcome measures

New PAD diagnosis

New prescriptions for guideline-recommended medications

New referral to cardiovascular specialist

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EHR AlertExperimental Treatment1 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 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.

Group II: No EHR AlertActive Control1 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,396 Previous Clinical Trials

17,341,505 Total Patients Enrolled

6 Trials studying Peripheral Arterial Disease

51,524 Patients Enrolled for Peripheral Arterial Disease

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,843 Previous Clinical Trials

47,817,058 Total Patients Enrolled

52 Trials studying Peripheral Arterial Disease

108,886 Patients Enrolled for Peripheral Arterial Disease

Elsie Ross, MD, MScPrincipal InvestigatorStanford University

Media Library

High PAD risk Alert Clinical Trial Eligibility Overview. Trial Name: NCT04054232 — N/A

Peripheral Arterial Disease Research Study Groups: EHR Alert, No EHR Alert

Peripheral Arterial Disease Clinical Trial 2023: High PAD risk Alert Highlights & Side Effects. Trial Name: NCT04054232 — N/A

High PAD risk Alert 2023 Treatment Timeline for Medical Study. Trial Name: NCT04054232 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there eligibility requirements for joining this medical research endeavor?

"The prospective participants to be eligible for this trial should have peripheral arterial disease, and must lie within the age limit of 50-85 years. Approximately fifty persons are sought out to participate in this study."

Answered by AI

Would people aged 55 and above be accepted into this clinical experiment?

"According to the specifications of this investigation, only patients between 50 and 85 years old are able to participate. Since there are 15 trials for minors and 277 investigations that cater to adults over 65, those outside of this age range have other options available."

Answered by AI

Are researchers still seeking volunteers for this investigation?

"According to the details on clinicaltrials.gov, this particular study is not currently accepting patients. It was initially posted in December 1st of 2023 and its most recent edit occurred on July 11th of 2022. Despite this trial's unavailability at present, there are 289 other trials with open recruitment processes for those seeking participation opportunities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of an Electronic Health Record-based Screening Tool for Peripheral Artery Disease

Elsie Ross 2023. "Evaluation of an Electronic Health Record-based Screening Tool for Peripheral Artery Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04054232.

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