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Centralized Prescribing for Statins

Primary Purpose

Hyperlipidemias

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-visit Based Intervention
Visit-Based Intervention
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hyperlipidemias

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Lancaster General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Non-visit Based Intervention

Visit-Based Intervention

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 7, 2022
Last Updated
October 11, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05537064
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
June 13, 2023 (Actual)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1950 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm 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.
Arm Title
Non-visit Based Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Visit-Based Intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Non-visit Based Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Visit-Based Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Prescribed a Statin (population level)
Description
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.
Time Frame
9 months
Title
Number of Participants Prescribed a Statin (office-visit level)
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Statin Pharmacy Dispense Rate
Description
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.
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
LDL Control
Description
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.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Fanaroff, MD, MHS
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States

12. IPD Sharing Statement

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Centralized Prescribing for Statins

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