Centralized Prescribing for Statins (NCT05537064) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Centralized Prescribing for Statins
United States1,950 participantsStarted 2022-11-02
Plain-language summary
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.
Who can participate
Age range
21 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Primary Care Providers with at least 10 patients among their entire panel who meet the following criteria:
* Have a LGH PCP, AND
* 21-75 years old, AND
* An indication for high- or moderate-intensity statin, AND
* Pooled cohort risk equation 10-year ASCVD risk greater than 10%, OR
* diabetes mellitus, OR
* very high LDL-C \> 190 mg/dL, OR
* familial hyperlipidemia, OR
* established ASCVD,
* Not currently on statin therapy, OR on low dose-statin therapy
Exclusion Criteria:
* Have an allergy to statins
* Severe renal insufficiency defined as glomerular filtration rate (GFR) less than 30 mL/min or on dialysis
* Adverse reaction to statins including statin-related a) myopathy; b) Rhabdomyolysis; c) hepatitis
* Pregnant
* Currently breastfeeding
* On hospice or at the end-of-life
* On a PCSK9 Inhibitor medication
* Physicians (and their respective patients) will be excluded if they have less than 10 patients among their entire panel that are eligible for a statin medication.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Prescribed a Statin (population level)
Timeframe: 9 months
2
Number of Participants Prescribed a Statin (office-visit level)