Reminders for Prescribing Statins for High Cholesterol

Overseen By Kylie Nairon, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must not be taking: Statins, Ezetimibe

Disqualifiers: Pregnant, Lactating, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

6000 Participants Needed

Trial Summary

What is the purpose of this 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.

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 data supports the effectiveness of the treatment Statin Reminders for high cholesterol?

Research shows that using electronic or paper reminders can improve adherence to statin prescriptions, which are important for managing cholesterol and preventing heart disease. For example, one study found that electronic reminders helped patients stick to their statin treatment, leading to better health outcomes. ^{1 2 3 4 5}

Is statin therapy generally safe for humans?

Statins are generally well tolerated and have a low frequency of serious side effects, but they can sometimes cause muscle pain, new-onset diabetes, and rare cases of liver or kidney issues. Most side effects are not common and often resolve when treatment is stopped. ^{6 7 8 9 10}

How does the reminder system for prescribing statins differ from other treatments for high cholesterol?

This treatment is unique because it uses reminders, either electronic or paper-based, to help doctors and patients remember to manage cholesterol levels effectively. Unlike other treatments that focus solely on medication, this approach aims to improve adherence to statin therapy by ensuring that both patients and healthcare providers follow guidelines consistently. ^{1 2 3 11 12}

Research Team

Aileen P Wright, MD, MS

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: No Reminder Group Active Control 1 Intervention

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.

Group II: Interruptive Reminder Group Active Control 1 Intervention

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.

Group III: Non-Interruptive Reminder Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rosuvastatin safety: a comprehensive, international pharmacoepidemiology programme. Johansson, S., Ming, EE., Wallander, MA., et al.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

Outcomes of patients discharged from pharmacy-managed cardiovascular disease management. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Using paper chart based clinical reminders to improve guideline adherence to lipid management. [2015]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Does the use of an electronic reminder device with or without counseling improve adherence to lipid-lowering treatment? The results of a randomized controlled trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Increasing statin prescription rates to prevent cardiovascular disease among high-risk populations: a quality improvement intervention centred on a novel interactive tool. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Patient-Centered Interventions to Improve Adherence to Statins: A Narrative Synthesis of Systematically Identified Studies. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Rosuvastatin safety: a comprehensive, international pharmacoepidemiology programme. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Statins, cardiovascular disease, and drug safety. [2006]

8. England pubmed.ncbi.nlm.nih.gov

Interpretation of the evidence for the efficacy and safety of statin therapy. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Addressing statin adverse effects in the clinic: the 5 Ms. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Benefit versus risk in statin treatment. [2007]

11. Spain pubmed.ncbi.nlm.nih.gov

[Therapy compliance in cases of hyperlipaemia, as measured through electronic monitors. Is a reminder calendar to avoid forgetfulness effective?]. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Improved cholesterol management in coronary heart disease patients enrolled in an HMO. [2019]