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OpenTrials
Completed

NCT Number: NCT06456658

Statin Reminders for Improving Prescribing in Primary Care

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.

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Key information

Conditions

Cholesterol, Elevated Clinical Decision Support Dyslipidemias Education Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interruptive Reminder

Other

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

Other

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

Other

No reminder recommending a statin will be displayed/available to the provider.

Primary outcomes

  1. Statin prescription within 24 hours

    Time frame: Baseline to 24-hours

    Statin prescription within 24 hours post-enrollment (either interruptive, non-interruptive, or silent/hidden reminder).

Secondary outcomes

  1. Statin prescription within 12 months

    Time frame: Baseline to 12 months

    Statin prescription within 12 months post-enrollment.

  2. Low density lipoprotein-cholesterol (LDL-C) level

    Time frame: Baseline to 12 months

    One LDL-C level within 12 months post-enrollment.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Interruptive Versus Non-Interruptive Reminders for Statin tHerApy in Primary Care (INIRSHA-PC). A Randomized Trial.

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 13, 2024
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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