Centralized Statin Prescribing Strategies for High Cholesterol
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two methods to help doctors refer patients to a special pharmacy service for managing high cholesterol with statins (cholesterol-lowering drugs). One method provides a reminder during a doctor's visit, while the other sends a message to doctors outside of visits. Suitable candidates have high cholesterol concerns, are not currently on high-intensity statins, and have either diabetes, a history of heart disease, or very high LDL (bad cholesterol) levels. Participants in this trial will help researchers identify the best approach to ensure more people receive effective cholesterol-lowering treatment. As an unphased trial, this study offers a unique opportunity to contribute to improving healthcare practices for managing high cholesterol.
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 prior data suggests that these methods for statin management are safe?
Research has shown that statin medications are generally safe and effective for most people. They lower cholesterol and reduce the risk of heart disease. However, some individuals might experience side effects such as muscle pain, digestive issues, or changes in liver function. These side effects are usually mild and affect only a small number of people.
The clinical trials aim to improve how doctors recommend statins to patients. Both methods focus on encouraging the use of statins in patients at high risk for heart problems. Previous studies on similar methods have not identified any major safety issues.
These methods guide doctors in prescribing statins but do not alter the safety of the statins themselves. Instead, they ensure that patients who need statins receive them. Overall, for those considering joining a trial involving statins, current evidence suggests that the medication is safe for most people.12345Why are researchers excited about this trial?
Researchers are excited about these new strategies for managing high cholesterol because they offer a fresh approach to prescribing statins, which are the standard treatment for this condition. Unlike traditional methods that rely on in-person visits, the non-visit-based intervention uses digital nudges, like EPIC In-basket messages, to streamline patient referrals to centralized pharmacy services. This can potentially make statin management more efficient and accessible. Meanwhile, the visit-based intervention introduces an interruptive Best Practice Advisory during non-acute visits, prompting timely referrals for statin initiation. These innovative approaches aim to enhance adherence to statin therapy and optimize cholesterol management without the need for frequent office visits, which could lead to better health outcomes for patients.
What evidence suggests that this trial's interventions could be effective for managing high cholesterol?
Research shows that gentle reminders, or "nudges," can increase the use of statins, medicines that lower cholesterol. This trial will include participants in different arms to evaluate these strategies. The Visit-Based Intervention arm will test reminders given to doctors during regular check-ups; studies have found that these reminders increase the number of patients starting statins. The Non-visit Based Intervention arm will assess the impact of reminders sent to doctors outside of visits, such as messages, which have also increased statin prescriptions. These strategies help doctors remember to prescribe statins, which reduce heart problems. By making it easier for doctors to guide patients to pharmacy services, these nudges could improve cholesterol management and lower the risk of heart disease.16789
Who Is on the Research Team?
Alexander Fanaroff, MD, MHS
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for statin prescription rates and LDL control
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Published Research Related to This Trial
Citations
Effect of Nudges to Clinicians, Patients, or Both to Increase ...
Nudges to clinicians with and without a patient nudge significantly increased initiation of a statin prescription during primary care visits.
Interventions to improve adherence to lipid-lowering drugs
Our findings show that while interventions were generally effective in improving medication adherence, both as continuous (SMD 0.17, 95% CI [ ...
Nudges for Statin Prescribing in Primary Care
Statins have been demonstrated to be an effective tool for reducing the risk of CVD-related events and mortality, but statins are often not prescribed for ...
Two Randomized Controlled Trials of Nudges to Encourage ...
For the non-visit-based nudge (Trial #2), the denominator for the primary outcome will include a randomly selected cohort of eligible patients assigned to PCPs ...
5.
clinicaltrialresults.org
clinicaltrialresults.org/wp-content/uploads/2023/11/SUPER-LIPID-LBCT-distribution_Alexander-Fanaroff.pdfSUPER-LIPID-LBCT-distribution_Alexander-Fanaroff.pdf
Results – cluster RCT of non-visit-based intervention. Baseline characteristics. Intervention Usual care. (n = 975). (n = 975) p value. Age 63.3 ± 10.3 64.6 ...
6.
jamanetwork.com
jamanetwork.com/journals/jamacardiology/articlepdf/2832031/jamacardiology_fanaroff_2025_oi_250005_1746663977.68707.pdf?resultClick=1Encouraging Pharmacist Referrals for ...
In trial 2, semiautomated pharmacist referrals were associated with an increase in statin prescriptions by 16 percentage points compared with ...
Centralized Statin Prescribing Strategies for High Cholesterol
This N/A medical study run by University of Pennsylvania needs participants to evaluate whether Non-visit Based Intervention and Visit-Based Intervention ...
Two randomized controlled trials of nudges to encourage ...
SUPER LIPID is a pair of pragmatic clinical trials assessing the effectiveness of two strategies to encourage referral of appropriate patients to a centralized ...
Encouraging Pharmacist Referrals for Evidence-Based ...
Statins are inexpensive, well tolerated, and substantially reduce cardiovascular events in patients at high risk, but most individuals in the US ...
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