Centralized Prescribing for Statins

A Pilot Study of Strategies to Increase Use of Centralized Pharmacy Services for Management of Statin Therapy Among Patients With or at High Risk for Atherosclerotic Vascular Disease

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.

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.

For trial #1, the investigators will identify PCPs at a single practice with at least 10 patients on their panel who are eligible for but not yet prescribed high- or moderate-intensity statin medication. These physicians will be randomized in stepped-wedge fashion to usual care or to a nudge, delivered at the time of a scheduled office visit, to refer appropriate patients to centralized pharmacy services for initiation and/or titration of a statin medication. In trial #2, the investigators will identify PCPs at 12 practices with at least 10 patients on their panel who are eligible for but not yet prescribed high- or moderate-intensity statin medication. Practices will be randomized to usual care or to a non-visit-based nudge to refer appropriate patients to centralized pharmacy services for initiation and/or titration of a statin medication. It is estimated that 13 practices and 83 providers will be eligible to participate in the two trials. The invesitgators will run the intervention over a 9-month time frame.

The primary outcome is the prescription of a statin for eligible patients during the 9-month timeframe. Secondary outcomes will include the prescription of guideline-directed intensity of statin medications as well as statin pharmacy dispense rate. The investigators will also assess LDL control over the study period.

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.