Peripheral Artery DiseaseNCT05166187
Best Practice Advisory to Initiate High-Intensity Statin Therapy in Patients With Peripheral Artery Disease
A study testing Best Practice Advisory in people with Peripheral Artery Disease, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to understand how a Best Practice Advisory (BPA) for high-intensity statin therapy in patients with Peripheral Artery Disease impacts prescription rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Best Practice Advisory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2022to 13 Nov 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary hospital diagnosis of PAD defined by ICD/CPT codes
- Inpatient status at the adult hospital at Vanderbilt University Medical Center
- Not currently prescribed a high-intensity statin (atorvastatin 40-80mg daily or rosuvastatin 20-40mg daily)
Who cannot join
- On comfort measures
- History of statin allergy or intolerance recorded in the EMR
- History of rhabdomyolysis defined by International Classification of Diseases/Current Procedural Terminology (ICD/CPT) codes
- History of hepatitis A, B, or C defined by ICD/CPT codes
- Pregnant
- Aspartate aminotransferase >120 units/L within 30 days of alert
Show all 9Show fewer
- Alanine aminotransferase >165 units/L within 30 days of alert
- Primary hospital diagnosis of acute myocardial infarction defined by ICD/CPT codes
- Primary hospital diagnosis of acute stroke defined by ICD/CPT codes
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The purpose of this study is to understand how a Best Practice Advisory (BPA) for high-intensity statin therapy in patients with Peripheral Artery Disease impacts prescription rates.
Read the detailed description
The central hypothesis is that an automated best practice advisory embedded within the electronic medical record (EMR) will improve prescription of high-intensity statins among hospitalized patients with Peripheral Artery Disease (PAD).
Aim 1: To assess the impact of an automated best practice advisory, deployed as part of the standard hospital discharge workflow within the electronic medical record, on high-intensity statin prescription among hospitalized patients with PAD.
Aim 2: To assess the impact of an automated best practice advisory, deployed as part of the standard hospital discharge workflow within the electronic medical record, on short-term cardiovascular outcomes among hospitalized patients with PAD.
- Conditions
- Peripheral Artery Disease
- Being tested
- Best Practice Advisory
- Keywords
- Peripheral Artery Disease, Statin, Electronic alert, Best Practice Advisory
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Practice AdvisoryOther
Patients in this arm will have a Best Practice Advisory displayed in the Electronic Medical Record (EMR) as part of the discharge order workflow.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients randomized to the intervention arm will have a Best Practice Advisory (BPA) displayed as part of the discharge order workflow. This BPA requires clinicians to choose an option before completing the discharge documentation. Options include ordering one of the appropriate statins or documenting that the medication is contraindicated, the patient declined, or the patient does not meet criteria for a high-intensity statin. Receives: Other: Best Practice Advisory |
| Usual Care | No intervention | Patients randomized to the usual care arm will have the identical set of windows displayed in the discharge workflow minus the BPA window. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of High-Intensity Statin Prescription at discharge
Frequency will be measured by identifying the number of high-intensity statin prescriptions at discharge
Measured: Baseline, upon patient discharge through study completion, average of six months
Frequency of High-Intensity Statin Prescription at 90 days post-discharge
Frequency will be measured by identifying the number of high-intensity statin prescriptions at 90 days post-discharge.
Measured: 90 days post-discharge
Secondary outcomes (1)
Frequency of a Composite of Cardiovascular Events
Frequency will be measured by identifying the number of cardiovascular events including myocardial infarction, coronary revascularization, stroke, lower extremity arterial revascularization, or all-cause mortality.
Measured: Baseline, upon patient discharge to 90 days post-discharge through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start20 Apr 2022
- Primary completion13 Aug 2023
- Study completion13 Nov 2023
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 Vanderbilt University Medical CenterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron W. Aday, MD, MSc, Vanderbilt University Medical Center
- Investigators
- Aaron W Aday, MD, MSc, Principal investigator, VUMC Cardiovascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166187
- Sponsor's protocol ID
- 212294
- Status last verified
- Jan 2024
- First submitted
- 6 Dec 2021
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Practice Advisory to Initiate High-Intensity Statin Therapy in Patients With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT05166187
- Acronym / sponsor ID
- 212294
- Conditions
- Peripheral Artery Disease
- Keywords
- Peripheral Artery Disease, Statin, Electronic alert, Best Practice Advisory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 13 Aug 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 21 Dec 2021 (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.
The purpose of this study is to understand how a Best Practice Advisory (BPA) for high-intensity statin therapy in patients with Peripheral Artery Disease impacts prescription rates.
Detailed description
The central hypothesis is that an automated best practice advisory embedded within the electronic medical record (EMR) will improve prescription of high-intensity statins among hospitalized patients with Peripheral Artery Disease (PAD).
Aim 1: To assess the impact of an automated best practice advisory, deployed as part of the standard hospital discharge workflow within the electronic medical record, on high-intensity statin prescription among hospitalized patients with PAD.
Aim 2: To assess the impact of an automated best practice advisory, deployed as part of the standard hospital discharge workflow within the electronic medical record, on short-term cardiovascular outcomes among hospitalized patients with PAD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Best Practice AdvisoryPatients randomized to the intervention arm will have a Best Practice Advisory (BPA) displayed as part of the discharge order workflow. This BPA requires clinicians to choose an option before completing the discharge documentation. Options include ordering one of the appropriate statins or documenting that the medication is contraindicated, the patient declined, or the patient does not meet criteria for a high-intensity statin. |
| Usual Care | No intervention | –Patients randomized to the usual care arm will have the identical set of windows displayed in the discharge workflow minus the BPA window. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary hospital diagnosis of PAD defined by ICD/CPT codes
- Inpatient status at the adult hospital at Vanderbilt University Medical Center
- Not currently prescribed a high-intensity statin (atorvastatin 40-80mg daily or rosuvastatin 20-40mg daily)
Key exclusion criteria (9 listed)
- On comfort measures
- History of statin allergy or intolerance recorded in the EMR
- History of rhabdomyolysis defined by International Classification of Diseases/Current Procedural Terminology (ICD/CPT) codes
- History of hepatitis A, B, or C defined by ICD/CPT codes
- Pregnant
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 |
|---|---|---|
| Best Practice AdvisoryPatients in this arm will have a Best Practice Advisory displayed in the Electronic Medical Record (EMR) as part of the discharge order workflow. | Other | Intervention |
Primary outcome
Frequency of High-Intensity Statin Prescription at discharge
Time frame: Baseline, upon patient discharge through study completion, average of six months
Frequency will be measured by identifying the number of high-intensity statin prescriptions at discharge
Frequency of High-Intensity Statin Prescription at 90 days post-discharge
Time frame: 90 days post-discharge
Frequency will be measured by identifying the number of high-intensity statin prescriptions at 90 days post-discharge.
1 secondary outcome
Frequency of a Composite of Cardiovascular Events
Time frame: Baseline, upon patient discharge to 90 days post-discharge through study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
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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.
Aaron W Aday, MD, MSc principal investigator
VUMC Cardiovascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice Advisory in people with Peripheral Artery Disease, run by Vanderbilt University Medical Center 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 10 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of High-Intensity Statin Prescription at discharge (time frame: Baseline, upon patient discharge through study completion, average of six months). The study lists 2 primary outcomes in all. 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 10 Jan 2024.