Skip to content

Statin Reminders for Improving Prescribing in Primary Care

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06456658
Enrollment
3332
Registered
2024-06-13
Start date
2024-08-14
Completion date
2025-11-19
Last updated
2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholesterol, Elevated, Clinical Decision Support, Education

Brief 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.

Interventions

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

OTHERInterruptive 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.

OTHERNon-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.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Statin prescription within 12 monthsBaseline to 12 monthsStatin prescription within 12 months post-enrollment.
Low density lipoprotein-cholesterol (LDL-C) levelBaseline to 12 monthsOne LDL-C level within 12 months post-enrollment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026