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

March 20, 2019 updated by: University of Pennsylvania
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4774

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Statin Prescribing Rate
Time Frame: Two Months
Percentage of patients eligible for a statin that have been prescribed a statin
Two Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2017

Primary Completion (Actual)

April 21, 2017

Study Completion (Actual)

April 21, 2017

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 13, 2017

First Posted (Estimate)

January 16, 2017

Study Record Updates

Last Update Posted (Actual)

June 20, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 826125

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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