Clinical trial NCT05537064: Centralized Prescribing for Statins
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hyperlipidemias
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 1950
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Prescribed a Statin (population level)
timeFrame: 9 months
measure: Number of Participants Prescribed a Statin (office-visit level)
timeFrame: 9 months
Secondary outcomes:
measure: Statin Pharmacy Dispense Rate
timeFrame: 9 months
Other outcomes:
measure: LDL Control
timeFrame: 9 months
Locations:
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Alexander Fanaroff, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: