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Pragmatic, Randomized Evaluation of Statin Active Choice to Reach Improved Outcomes Based on Evidence (PRESCRIBE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03021759
Recruitment Status : Completed
First Posted : January 16, 2017
Results First Posted : June 20, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
In this study, the investigators will conduct a pragmatic, cluster-randomized, controlled trial to evaluate an active choice intervention with and without social comparison feedback to increase physician statin prescribing rates for eligible patients.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Behavioral: Active choice Behavioral: Social comparison feedback Not Applicable

Detailed Description:
Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States. Strong evidence indicates that statin medications can reduce the risk of CVD and for those with CVD statins have been shown to reduce mortality. Despite this evidence, statins are under-prescribed. In this study, the investigators will test the effectiveness of nudges targeted to physicians using active choice and social comparisons feedback to increasing the rate at which statin medications are prescribed to patients eligible based on national practice guidelines.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4774 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Pragmatic, Randomized Evaluation of Statin Active Choice to Reach Improved Outcomes Based on Evidence
Actual Study Start Date : February 21, 2017
Actual Primary Completion Date : April 21, 2017
Actual Study Completion Date : April 21, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
No intervention
Experimental: Active choice
Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin.
Behavioral: Active choice
Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin

Experimental: Active choice with social comparison feedback
Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. Physicians will receive social comparison feedback informing them of how their performance compares to their peers
Behavioral: Active choice
Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin

Behavioral: Social comparison feedback
Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers




Primary Outcome Measures :
  1. Statin Prescribing Rate [ Time Frame: Two Months ]
    Percentage of patients eligible for a statin that have been prescribed a statin



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient has a primary care physician at University of Pennsylvania Health System
  • Patient meets 2013 AHA/ACC guidelines for statin therapy but no record of a statin prescription in the electronic health record

Exclusion Criteria:

  • Patient has an allergy or adverse reaction to statins documented in the electronic health record
  • Patient has glomerular filtration rate less than 30 mL/min
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03021759


Locations
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United States, Pennsylvania
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Mitesh Patel, MD, MBA, MS University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03021759    
Other Study ID Numbers: 826125
First Posted: January 16, 2017    Key Record Dates
Results First Posted: June 20, 2019
Last Update Posted: June 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases