Statin Reminders for Improving Prescribing in Primary Care
NCT ID: NCT06456658
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
3332 participants
INTERVENTIONAL
2024-08-14
2025-11-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Interruptive Reminder Group
Providers will receive education via a pop-up alert at the time that the chart is opened for eligible patient visits assigned to the interruptive reminder group.
Interruptive Reminder
The reminder will display at the time the chart is opened for eligible patient visits and alert clinicians that a statin is recommended for the patient and list the reasons the statin is indicated. It will give the clinicians a defaulted option for statin prescription as well as alternatives. If the clinician accepts the alert, an order for a statin will be placed in their "shopping cart" for convenience, and the order can be signed to prescribe the medication. If the clinician does not wish to prescribe a statin from the reminder, they can choose an acknowledgement reason.
Non-Interruptive Reminder Group
Providers will be able to seek out education at their own initiative via an on-demand reminder within a section of the chart for eligible patient visits assigned to the non-interruptive reminder group.
Non-interruptive Reminder
The reminder will have the same format as the interruptive reminder group, but it will not be displayed unless providers seek out the education at their own initiative. The reminder will alert clinicians that a statin is recommended for the patient and list the reasons the statin is indicated. It will give the clinicians a defaulted option for statin prescription as well as alternatives. If the clinician accepts the alert, an order for a statin will be placed in their "shopping cart" for convenience, and the order can be signed to prescribe the medication. If the clinician does not wish to prescribe a statin from the reminder, they can choose an acknowledgement reason.
No Reminder Group
No alert recommending a statin will be displayed/available to the provider. The system will record eligibility through triggering a "silent" reminder, which is not displayed to the clinician and exists solely for data collection purposes.
No Reminder
No reminder recommending a statin will be displayed/available to the provider.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Interruptive Reminder
The reminder will display at the time the chart is opened for eligible patient visits and alert clinicians that a statin is recommended for the patient and list the reasons the statin is indicated. It will give the clinicians a defaulted option for statin prescription as well as alternatives. If the clinician accepts the alert, an order for a statin will be placed in their "shopping cart" for convenience, and the order can be signed to prescribe the medication. If the clinician does not wish to prescribe a statin from the reminder, they can choose an acknowledgement reason.
Non-interruptive Reminder
The reminder will have the same format as the interruptive reminder group, but it will not be displayed unless providers seek out the education at their own initiative. The reminder will alert clinicians that a statin is recommended for the patient and list the reasons the statin is indicated. It will give the clinicians a defaulted option for statin prescription as well as alternatives. If the clinician accepts the alert, an order for a statin will be placed in their "shopping cart" for convenience, and the order can be signed to prescribe the medication. If the clinician does not wish to prescribe a statin from the reminder, they can choose an acknowledgement reason.
No Reminder
No reminder recommending a statin will be displayed/available to the provider.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Seen in primary care visit within Vanderbilt University Medical Center
* Eligible for statin therapy due to 1) Atherosclerotic cardiovascular disease (ASCVD) 10- year risk greater than or equal to 10%, 2) Type 1 or 2 diabetes and aged 40 years or older, or 3) ASCVD diagnosis
Exclusion Criteria
* Last low-density lipoprotein cholesterol (LDL-C) less than 100 mg/dL
* Pregnant or lactating
* Palliative care
* Statin allergy or adverse effect of statin
* Rhabdomyolysis
* Statin contraindicated due to liver disease, defined as 1) Decompensated liver disease, 2) AST or ALT greater than 5 times the upper limit of normal, or 3) Total bilirubin greater than 1.5 mg/dL
* Statin contraindicated due to kidney disease, defined as 1) Dialysis or 2) Estimated glomerular filtration rate less than 15 ml/min/1.73m\^2
* Has had coronary calcium computerized tomography
* Less than 3 months since lipid panel resulted
* Acute visit
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vanderbilt University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Aileen P. Wright
Principal Investigator, Instructor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Aileen P Wright, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
240419
Identifier Type: -
Identifier Source: org_study_id