Centralized Statin Prescribing Strategies for High Cholesterol

Overseen By Kayla Clark, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must be taking: Statins

Must not be taking: PCSK9 Inhibitors

Disqualifiers: Statin allergy, Severe renal insufficiency, others

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

Compensation: Varies

Number of Visits: Unknown

1950 Participants Needed

Trial Summary

What is the purpose of this trial?

This pilot study consists of a pair of pragmatic clinical trials that will evaluate two separate methods for optimizing referral of eligible patients to a centralized pharmacy service for statin management: 1) A stepped wedge clinical trial, with randomization at the level of the provider, evaluating a visit-based nudge for referral to pharmacy services versus usual care; 2) A cluster randomized trial, with randomization at the level of the practice, evaluating a non-visit based nudge for referral to pharmacy services versus usual care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that participants are either not on statin therapy or only on a low-dose statin. If you are on a PCSK9 Inhibitor, you cannot participate.

What data supports the effectiveness of the treatment for high cholesterol in the clinical trial titled 'Centralized Statin Prescribing Strategies for High Cholesterol'?

Research shows that interventions, such as pharmacist-led programs and interactive tools, can improve statin prescription rates and help patients achieve cholesterol targets. These strategies have been effective in increasing statin use and monitoring cholesterol levels, which are important for managing high cholesterol. ^{1 2 3 4 5}

Is it safe to use statins for high cholesterol?

Statins are generally safe for most people, but some may experience side effects. A small number of patients might have adverse effects, but these are usually manageable with proper guidance from healthcare providers. ^{1 6 7 8 9}

How does the centralized statin prescribing strategy differ from other cholesterol treatments?

The centralized statin prescribing strategy is unique because it involves a coordinated approach to switching patients to appropriate statin medications, often using tools and guidelines to improve prescription rates and adherence. This strategy focuses on improving the overall management of statin therapy, rather than just prescribing the medication, which can lead to better outcomes in managing high cholesterol. ^{1 2 3 6 7}

Research Team

Alexander Fanaroff, MD, MHS

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for primary care providers with patients aged 21-75 who need high or moderate-intensity statin therapy but aren't currently on it, or are on a low dose. Patients should have a risk of heart disease over the next ten years greater than 10%, diabetes, very high LDL cholesterol, familial hyperlipidemia, or established heart disease.

Inclusion Criteria

I am a PCP with at least 10 patients needing high or moderate-intensity statin therapy.

Exclusion Criteria

You are allergic to statin medications.

I am currently taking a PCSK9 inhibitor medication.

Currently breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized to either a visit-based or non-visit-based nudge to refer eligible patients to centralized pharmacy services for statin management

9 months

Varies based on intervention type

Follow-up

Participants are monitored for statin prescription rates and LDL control

9 months

Treatment Details

Interventions

• Non-visit Based Intervention
• Visit-Based Intervention

Trial Overview The study tests two methods to encourage referrals to pharmacy services for managing statins: one during patient visits and another outside of visits. Providers are randomly chosen to suggest these services differently in their practices.

Participant Groups

Group I: Visit-Based Intervention Experimental Treatment 1 Intervention

In this arm the investigators will evaluate a visit-based nudge to refer to centralized pharmacy services to refer patients eligible for but not prescribed high-intensity statins to centralized pharmacy services for initiation and/or titration of a statin. Physicians in a single practice will be randomized to usual care versus visit-based nudge. The visit-based nudge will consist of an interruptive Best Practice Advisory (BPA) in the EMR that will trigger during non-acute patient visits and will prompt the provider to refer the patient to a centralized pharmacy service for statin initiation and management.

Group II: Non-visit Based Intervention Experimental Treatment 1 Intervention

In this arm the investigators will evaluate a non-visit-based nudge to refer patients eligible for but not prescribed high-intensity statins to centralized pharmacy services for initiation and/or titration of a statin. Practices will be randomized to usual care versus the non-visit-based nudge. The non-visit-based nudge will consist of an EPIC In-basket message sent to each provider that identifies their patients eligible for but not prescribed high- or moderate-intensity statins and notifies them that pended orders for a referral to centralized pharmacy services for statin management will be entered for these patients unless the provider opts out. At the time the in-basket message is sent out, PCPs will also have the opportunity to opt out of participating in the trial entirely.

Group III: Control Active Control 1 Intervention

Control arm exposed only to usual care, which consists of the passive decision support functionality Health Maintenance flag that is the current decision-support tool in the EMR.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Findings from Research

Although statin-associated adverse effects are rare, their increasing use has led to a notable number of patients experiencing these issues, necessitating referrals to specialists.

This report offers a consensus approach for effectively managing statin-related side effects, aiming to optimize treatment for patients needing cardiovascular risk reduction while minimizing unnecessary testing and referrals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis, prevention, and management of statin adverse effects and intolerance: proceedings of a Canadian Working Group Consensus Conference. Mancini, GB., Baker, S., Bergeron, J., et al.[2012]

References

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

Comparison of a pharmacist-managed lipid clinic: in-person versus telephone. [2010]

2. 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]

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

Moving from A to Z: successful implementation of a statin switch program by a large physician group. [2018]

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

A cluster randomised controlled trial of a pharmacist-led collaborative intervention to improve statin prescribing and attainment of cholesterol targets in primary care. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

[Great discrepancies between European, Dutch and Belgian criteria for the use of statins in the prevention of primary cardiovascular disease in family practice]. [2010]

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

Lipid-lowering efficacy, safety, and costs of a large-scale therapeutic statin formulary conversion program. [2019]

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

Effects of Guideline and Formulary Changes on Statin Prescribing in the Veterans Affairs. [2020]

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

Diagnosis, prevention, and management of statin adverse effects and intolerance: proceedings of a Canadian Working Group Consensus Conference. [2012]

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

Modifiable statin characteristics associated with potential statin-related prescribing cascades. [2023]