Centralized Prescribing for Statins

University of Pennsylvania

Status: Active, not recruiting

Conditions: Hyperlipidemias

Treatments: Behavioral: Visit-Based Intervention; Behavioral: Non-visit Based Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05537064

851668

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,950 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,950 participants in 3 patient groups

Control

No Intervention group

Description:

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.

Non-visit Based Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Non-visit Based Intervention

Visit-Based Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Visit-Based Intervention