Cholesterol, ElevatedNCT06456658
Statin Reminders for Improving Prescribing in Primary Care
A study testing Interruptive Reminder, Non-interruptive Reminder and No Reminder in people with Cholesterol, Elevated and Clinical Decision Support, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholesterol, Elevated, Clinical Decision Support, Education
- What is being tested?
- Interruptive Reminder, Non-interruptive Reminder and No Reminder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,332 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to 19 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
Official title: Interruptive Versus Non-Interruptive Reminders for Statin tHerApy in Primary Care (INIRSHA-PC). A Randomized Trial.
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.
- Conditions
- Cholesterol, Elevated, Clinical Decision Support, Education
- Being tested
- Interruptive Reminder, Non-interruptive Reminder, No Reminder
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interruptive ReminderOther
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 ReminderOther
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 ReminderOther
No reminder recommending a statin will be displayed/available to the provider.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interruptive Reminder |
| 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. Receives: Other: Non-interruptive Reminder |
| 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. Receives: Other: No Reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statin prescription within 24 hours
Statin prescription within 24 hours post-enrollment (either interruptive, non-interruptive, or silent/hidden reminder).
Measured: Baseline to 24-hours
Secondary outcomes (2)
Statin prescription within 12 months
Statin prescription within 12 months post-enrollment.
Measured: Baseline to 12 months
Low density lipoprotein-cholesterol (LDL-C) level
One LDL-C level within 12 months post-enrollment.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start14 Aug 2024
- Primary completion20 Nov 2024
- Study completion19 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholesterol, ElevatedStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3,332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aileen P. Wright, Vanderbilt University Medical Center
- Investigators
- Aileen P Wright, MD, MS, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456658
- Sponsor's protocol ID
- 240419
- Status last verified
- Dec 2025
- First submitted
- 7 Jun 2024
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.
Publications
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.
PubMed 41605591
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interruptive Versus Non-Interruptive Reminders for Statin tHerApy in Primary Care (INIRSHA-PC). A Randomized Trial.
- ClinicalTrials.gov ID
- NCT06456658
- Acronym / sponsor ID
- 240419
- Conditions
- Cholesterol, Elevated, Clinical Decision Support, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,332 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interruptive Reminder Group | Active comparator | Other: Interruptive ReminderProviders 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 comparator | Other: Non-interruptive ReminderProviders 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 comparator | Other: No ReminderNo 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interruptive ReminderThe 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. | Other | Interruptive Reminder Group |
| Non-interruptive ReminderThe 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. | Other | Non-Interruptive Reminder Group |
| No ReminderNo reminder recommending a statin will be displayed/available to the provider. | Other | No Reminder Group |
Primary outcome
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).
2 secondary outcomes
Statin prescription within 12 months
Time frame: Baseline to 12 months
Low density lipoprotein-cholesterol (LDL-C) level
Time frame: Baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Derived from this study: PubMed 41605591Wright 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aileen P Wright, MD, MS principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interruptive Reminder, Non-interruptive Reminder and No Reminder in people with Cholesterol, Elevated and Clinical Decision Support, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statin prescription within 24 hours (time frame: Baseline to 24-hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06456658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.