Statin Reminders for Improving Prescribing in Primary Care
Interruptive Versus Non-Interruptive Reminders for Statin tHerApy in Primary Care (INIRSHA-PC). A Randomized Trial.
1 other identifier
interventional
3,332
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2024
CompletedFirst Posted
Study publicly available on registry
June 13, 2024
CompletedStudy Start
First participant enrolled
August 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2025
CompletedDecember 16, 2025
December 1, 2025
3 months
June 7, 2024
December 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Statin prescription within 12 months
Baseline to 12 months
Low density lipoprotein-cholesterol (LDL-C) level
Baseline to 12 months
Study Arms (3)
Interruptive Reminder Group
ACTIVE COMPARATORProviders 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.
Non-Interruptive Reminder Group
ACTIVE COMPARATORProviders 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.
No Reminder Group
ACTIVE COMPARATORNo 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.
Interventions
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 recommending a statin will be displayed/available to the provider.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
Related Publications (1)
Wright AP, Choi L, Nairon KG, Gatto CL, Dear ML, Van Winkle G, Lagalante S, Neal EB, Wright A, Rice TW; Vanderbilt Center for Learning Healthcare. Interruptive versus Non-Interruptive Reminders for Statin tHerApy in Primary Care (INIRSHA-PC): protocol and statistical analysis plan for a randomised clinical trial. BMJ Open. 2026 Jan 28;16(1):e108123. doi: 10.1136/bmjopen-2025-108123.
PMID: 41605591DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aileen P Wright, MD, MS
Vanderbilt University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Instructor
Study Record Dates
First Submitted
June 7, 2024
First Posted
June 13, 2024
Study Start
August 14, 2024
Primary Completion
November 20, 2024
Study Completion
November 19, 2025
Last Updated
December 16, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.
- Access Criteria
- Data will be made accessible to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.
Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.