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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interruptive Reminder Group | Active Comparator | Providers 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. |
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| Non-Interruptive Reminder Group | Active Comparator | Providers 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. |
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| No Reminder Group | Active Comparator | No 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Statin prescription within 24 hours | Statin prescription within 24 hours post-enrollment (either interruptive, non-interruptive, or silent/hidden reminder). | Baseline to 24-hours |
| Measure | Description | Time Frame |
|---|---|---|
| Statin prescription within 12 months | Statin prescription within 12 months post-enrollment. | Baseline to 12 months |
| Low density lipoprotein-cholesterol (LDL-C) level | One LDL-C level within 12 months post-enrollment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aileen P Wright, MD, MS | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41605591 | Derived | 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. |
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Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.
The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 12, 2024 | Dec 8, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 29, 2024 | Sep 19, 2025 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| 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. |
|
| Baseline to 12 months |
| D009750 |
| Nutritional and Metabolic Diseases |