Clinical trial NCT06456658: Statin Reminders for Improving Prescribing in Primary Care
Official title: Interruptive Versus Non-Interruptive Reminders for Statin THerApy in Primary Care (INIRSHA-PC). a Randomized Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cholesterol, Elevated
Clinical Decision Support
Education
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Statin prescription within 24 hours
timeFrame: Baseline to 24-hours
Secondary outcomes:
measure: Statin prescription within 12 months
timeFrame: Baseline to 12 months
measure: Low density lipoprotein-cholesterol (LDL-C) level
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Aileen P Wright, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: