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Centralized Statin Prescribing Strategies for High Cholesterol

N/A

Waitlist Available

Led By Alexander Fanaroff, MD, MHS

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

Study Summary

This trial will compare two methods for referral of patients to a centralized pharmacy service for statin management, to see which is more effective.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While this trial focuses on referral methods rather than direct medication effects, general side effects of statins can include muscle pain, increased blood sugar levels leading to diabetes risk, digestive problems, and rarely liver damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Number of Participants Prescribed a Statin (population level)

Secondary outcome measures

Statin Pharmacy Dispense Rate

Other outcome measures

LDL Control

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Visit-Based InterventionExperimental Treatment1 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 InterventionExperimental Treatment1 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: ControlActive Control1 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,878,138 Total Patients Enrolled

Alexander Fanaroff, MD, MHSPrincipal InvestigatorUniversity of Pennsylvania

5 Previous Clinical Trials

2,486 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people can join this clinical trial at its maximum capacity?

"The information available on clinicaltrials.gov suggests that this study is actively looking for patients to enroll. The trial was posted on November 2nd, 2020 and has since been updated on November 15th, 2020. So far, 84 people have signed up at the single location where the trial is taking place."

Answered by AI

Are there any current vacancies for patients who'd like to participate in this clinical trial?

"Yes, this is an active clinical trial that Needs participants according to the listing on clinicaltrials.gov. The study was posted on 11/2/2022 and last updated on 11/15/2022."

Answered by AI

Does this research project have an age limit for participants?

"The age limit for this clinical study are set at 21 years old and 75 years old."

Answered by AI

To what type of patients does this research extend?

"Up to 84 individuals that suffer from lipidemia and meet the following age, risk, and cholesterol criteria may be admitted into this trial. Candidates must be between 21-75 years old,, have a family history of hyperlipidemia,, or established ASCVD,, as well as an LGH PCP. In addition, they should not currently be receiving statin therapy at a low dose,, or their 10-year ASCVD risk should exceed 10% according to the Pooled cohort risk equation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Centralized Prescribing for Statins

2022. "Centralized Prescribing for Statins". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05537064.