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

NCT ID: NCT03021759

Last Updated: 2019-06-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4774 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-21

Study Completion Date

2017-04-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Active choice

Intervention Type BEHAVIORAL

Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin

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

Group Type EXPERIMENTAL

Active choice

Intervention Type BEHAVIORAL

Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin

Social comparison feedback

Intervention Type BEHAVIORAL

Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers

Interventions

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Active choice

Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin

Intervention Type BEHAVIORAL

Social comparison feedback

Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mitesh Patel, MD, MBA, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Patel MS, Kurtzman GW, Kannan S, Small DS, Morris A, Honeywell S Jr, Leri D, Rareshide CAL, Day SC, Mahoney KB, Volpp KG, Asch DA. Effect of an Automated Patient Dashboard Using Active Choice and Peer Comparison Performance Feedback to Physicians on Statin Prescribing: The PRESCRIBE Cluster Randomized Clinical Trial. JAMA Netw Open. 2018 Jul 6;1(3):e180818. doi: 10.1001/jamanetworkopen.2018.0818.

Reference Type DERIVED
PMID: 30646039 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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826125

Identifier Type: -

Identifier Source: org_study_id

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