Statin Reminders for Improving Prescribing in Primary Care

Education Clinical Trial

Official title:

Interruptive Versus Non-Interruptive Reminders Recommending Statin Prescribing in Primary Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06456658
• Other study ID #: 240419
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: June 2026

Study information

• Verified date: June 2024
• Source: Vanderbilt University Medical Center
• Contact: Aileen P Wright, MD, MS
• Phone: 615-936-2187
• Email: aileen.p.wright.1[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Statins reduce cardiovascular events and mortality, but only 30% of eligible primary care patients nationally are on statins. Clinical decision support (CDS) interventions in the electronic health record (EHR) can deliver education to providers and increase adherence to guideline recommendations via many potential forms of delivery. Interruptive alerts are an effective form of CDS but disrupt clinician workflow and increase alert fatigue in an age of clinician burnout and frustration with the EHR. Non-interruptive reminders are proposed as an alternative method of delivering CDS; however, they require active pursuit by the provider, and their effectiveness compared to interruptive alerts has not been rigorously studied. The investigators propose a randomized trial comparing the effect of interruptive vs. non-interruptive reminders displayed to clinicians to increase statin prescribing in primary care clinics.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6000
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients between the ages of 18 and 75

• 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:

• Already on statin, ezetimibe, bempedoic acid, or PCSK9 inhibitor

• 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

Related Conditions & MeSH terms

• Cholesterol, Elevated
• Clinical Decision Support
• Education
• Hypercholesterolemia

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Statin prescription within 24 hours	Statin prescription within 24 hours post-enrollment (either interruptive, non-interruptive, or silent/hidden reminder).	Baseline to 24-hours
Secondary	Statin prescription within 12 months	Statin prescription within 12 months post-enrollment.	Baseline to 12 months
Secondary	Low density lipoprotein-cholesterol (LDL-C) level	One LDL-C level within 12 months post-enrollment.	Baseline to 12 months