Reminders for Prescribing Statins for High Cholesterol

AP
KN
Overseen ByKylie Nairon, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the most effective way to remind doctors to prescribe statins, a medication that lowers cholesterol and reduces heart problems. During patient visits, doctors will receive either interruptive reminders (pop-up alerts) or non-interruptive reminders (on-demand information). The trial evaluates which type of reminder more effectively prompts doctors to prescribe statins. Individuals at high risk of heart disease or diabetes who are not currently taking statins may be suitable participants. As an unphased trial, this study provides a unique opportunity to enhance healthcare practices and patient outcomes.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are already on certain cholesterol-lowering drugs like statins, ezetimibe, bempedoic acid, or PCSK9 inhibitors.

What prior data suggests that these statin reminders are safe for use in clinical settings?

Research has shown that electronic or paper reminders can help doctors prescribe statins more frequently. Statins lower cholesterol, which is crucial for reducing the risk of heart attacks and strokes.

In a large study involving 170,000 people, statins proved to be safe and effective. Most participants did not experience serious side effects, with common side effects being mild, such as muscle pain or an upset stomach. These findings suggest that reminders for doctors can increase statin prescriptions without introducing new safety concerns.

Thus, when considering participation in a study involving statin reminders, it is reassuring to know that statins have generally been shown to be safe for many people.12345

Why are researchers excited about this trial?

Researchers are excited about these reminder systems for prescribing statins because they could revolutionize how doctors manage high cholesterol. Unlike current treatments that rely solely on medical guidelines and clinician judgment, these reminders introduce a proactive approach to decision-making. The interruptive reminders actively alert providers during patient visits, potentially increasing the likelihood of timely statin prescriptions. Meanwhile, the non-interruptive reminders offer flexibility, allowing providers to access information at their convenience, which can foster a more personalized treatment strategy. By integrating these reminder systems, the goal is to improve adherence to prescribing guidelines and ultimately enhance patient outcomes.

What evidence suggests that this trial's reminder methods could be effective for increasing statin prescribing?

This trial will compare different types of reminders for prescribing statins for high cholesterol. Studies have shown that pop-up alerts can effectively increase the prescribing of statins, which help manage cholesterol and reduce heart-related risks. However, these alerts can interrupt doctors' work and contribute to burnout. In this trial, one group of providers will receive pop-up alerts, known as the Interruptive Reminder Group. Another group, the Non-Interruptive Reminder Group, will have access to non-intrusive reminders that doctors need to seek out themselves. While these are less disruptive, their effectiveness compared to pop-up alerts has not been extensively studied. Research shows that using any type of reminder, whether electronic or on paper, can help ensure that statins are prescribed as needed. This is important for managing high cholesterol and preventing heart disease.46789

Who Is on the Research Team?

AP

Aileen P Wright, MD, MS

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for primary care providers who manage patients with high cholesterol. It aims to improve statin prescribing practices using different types of reminders within the electronic health record system.

Inclusion Criteria

Seen in primary care visit within Vanderbilt University Medical Center
I am eligible for statin therapy due to high heart disease risk, being over 40 with diabetes, or having ASCVD.

Exclusion Criteria

I am receiving care to manage cancer symptoms.
Last low-density lipoprotein cholesterol (LDL-C) less than 100 mg/dL
I am currently taking medication for cholesterol.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Providers receive either interruptive or non-interruptive reminders to increase statin prescribing

24 hours

Follow-up

Participants are monitored for statin prescription and LDL-C levels

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Statin Reminders
Trial Overview The study tests two methods of clinical decision support: interruptive reminders that prompt action during patient visits, and non-interruptive reminders that don't interfere with workflow but require clinicians to seek them out.
How Is the Trial Designed?
3Treatment groups
Active Control
Group I: No Reminder GroupActive Control1 Intervention
Group II: Interruptive Reminder GroupActive Control1 Intervention
Group III: Non-Interruptive Reminder GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

Published Research Related to This Trial

Rosuvastatin, the newest statin approved in the USA, has been shown to have a safety profile similar to other statins, with a low frequency of serious adverse events based on a comprehensive assessment involving over 50,000 patients.
AstraZeneca's ongoing pharmacoepidemiology program includes multiple studies designed to evaluate patient characteristics and safety, ensuring continuous monitoring of rosuvastatin's benefit-risk profile beyond initial clinical trials.
Rosuvastatin safety: a comprehensive, international pharmacoepidemiology programme.Johansson, S., Ming, EE., Wallander, MA., et al.[2016]

Citations

Interruptive Versus Non-Interruptive Reminders for Statin ...The system will record eligibility through triggering a “silent” alert, which is not displayed to the clinician and exists solely for data ...
Two Randomized Controlled Trials of Nudges to Encourage ...Previous nudges to increase statin prescribing have focused mostly on visit-based, interruptive EHR messages to clinicians, and have showed modest effectiveness ...
Reminders for Prescribing Statins for High CholesterolInterruptive alerts are an effective form of CDS but disrupt clinician workflow and increase alert fatigue in an age of clinician burnout and frustration with ...
Two randomized controlled trials of nudges to encourage ...Two randomized controlled trials of nudges to encourage referrals to centralized pharmacy services for evidence-based statin initiation in high-risk patients: ...
Statin Reminders for Improving Prescribing in Primary CareInterruptive alerts are an effective form of CDS but disrupt clinician workflow and increase alert fatigue in an age of clinician burnout and frustration with ...
Statin Reminders for Improving Prescribing in Primary CareThe data will become available 3 months following publication of outcomes and will remain available for at least 5 years. IPD Sharing Supporting Information ...
Real-World Prescribing for Lipid-Lowering Therapy - PMCEfficacy and safety of more intensive lowering of LDL-C cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials.
Pragmatic Trial of Messaging to Providers About Treatment ...Within each study arm, there were significant increases in prescriptions of high intensity statins and ezetimibe compared with baseline (Figure 2B; alert, 488 ...
Research Finds Targeted Reminders Increase ...The proportion of patients prescribed high-intensity statin therapy increased by 3.8% across all clinics in the intervention arm.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security