Centralized Prescribing for Statins

Hyperlipidemias Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05537064
• Other study ID #: 851668
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2022
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1950
• Est. completion date: December 2024
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipidemias

Intervention

Behavioral:
• Non-visit Based Intervention
At the beginning of the study period, PCPs will be sent an Inbasket message, a secure electronic messaging system included in EPIC, similar to an email. The message will notify them that pended orders for a referral to centralized pharmacy services for statin management will be entered for eligible patients unless the provider opts out. If no opt-out is received from the PCP within 7 days of receiving the message, their eligible patient panels will be referred to a centralized pharmacy team to begin pending referral orders to the PCP for eligible patients. Pharmacists affiliated with the centralized pharmacy service will then enter pended orders for referral to centralized pharmacy services that PCPs can sign either individually or in bulk. After the PCP signs the order for referral to centralized pharmacy services, a pharmacist from the centralized pharmacy team will then reach out to the patient on behalf of their PCP and discuss their indication for statin therapy.
• Visit-Based Intervention
The study team will build an interruptive BestPractice advisory (BPA), a pop-up notification in the EHR that is delivered to the PCP when they open the patient's chart during a non-acute patient visit. The BestPractice Advisory will describe the guideline criteria for which the patient is eligible for statin therapy, and recommend referral to a centralized pharmacy service for statin initiation and management. It will also include a link to a menu for prescribing an appropriate-dose statin, should the PCP want to prescribe a statin without referral to pharmacy services. The option for ordering referral to centralized pharmacy services will be pre-selected, such that if the PCP simply clicks "Accept" on the BPA, an order for referral to centralized pharmacy services for statin initiation and management will be generated.

Locations

Country	Name	City	State
United States	Lancaster General Hospital	Lancaster	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	LDL Control	We will also assess LDL control over the study period. We will compare the LDL between patients seeing physicians randomized to intervention vs. usual care. This analysis will be performed both on the population-level (all patients assigned to the practice or physician eligible for but not prescribed a high-intensity statin at the start of the trial) and among patients with an office visit during the study period.	9 months
Primary	Number of Participants Prescribed a Statin (population level)	The primary outcome is the prescription of a statin for eligible patients during the 9-month timeframe, assessed among all patients assigned to the physician or office eligible for but not prescribed a high-intensity statin at the start of the trial. The primary outcome will be compared between patients seeing physicians, or seen at practices, randomized to the intervention vs. usual care.	9 months
Primary	Number of Participants Prescribed a Statin (office-visit level)	The primary outcome is the prescription of a statin for eligible patients during the 9-month timeframe, assessed among all patients who had an office visit during the study period and were eligible for but not prescribed a high-intensity statin at the start of the trial. The primary outcome will be compared between patients seeing physicians, or seen at practices, randomized to the intervention vs. usual care.	9 months
Secondary	Statin Pharmacy Dispense Rate	Secondary outcomes will include the prescription of guideline-directed intensity of statin medications as well as statin pharmacy dispense rate. We will compare the proportion of eligible patients prescribed a guideline-concordant-intensity statin and the proportion filling a prescription for statin between patients seeing physicians randomized to intervention vs. usual care. This analysis will be performed both on the population-level (all patients assigned to the practice or physician eligible for but not prescribed a high-intensity statin at the start of the trial) and among patients with an office visit during the study period.	9 months