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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03021759
Acronym
PRESCRIBE
Enrollment
4774
Registered
2017-01-16
Start date
2017-02-21
Completion date
2017-04-21
Last updated
2019-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

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.

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.

Interventions

BEHAVIORALActive choice

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

BEHAVIORALSocial comparison feedback

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

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Statin Prescribing RateTwo MonthsPercentage of patients eligible for a statin that have been prescribed a statin

Countries

United States

Participant flow

Recruitment details

No informed consent was obtained from the participants in this study.

Participants by arm

ArmCount
Control
No intervention
1,566
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. Active choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin
1,743
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 Active choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin Social comparison feedback: Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers
1,465
Total4,774

Baseline characteristics

CharacteristicControlActive ChoiceActive Choice With Social Comparison FeedbackTotal
Age, Continuous62.1 years
STANDARD_DEVIATION 8.5
62.4 years
STANDARD_DEVIATION 8.2
62.5 years
STANDARD_DEVIATION 8.2
62.4 years
STANDARD_DEVIATION 8.3
Annual Household Income
>100,000 US$
341 Participants206 Participants312 Participants859 Participants
Annual Household Income
50,000 - 100,000 US$
784 Participants960 Participants733 Participants2477 Participants
Annual Household Income
<50,000 US$
435 Participants563 Participants406 Participants1404 Participants
Annual Household Income
Missing
6 Participants14 Participants14 Participants34 Participants
Race/Ethnicity, Customized
Black non-Hispanic
420 Participants479 Participants419 Participants1318 Participants
Race/Ethnicity, Customized
Other
142 Participants154 Participants120 Participants416 Participants
Race/Ethnicity, Customized
White non-Hispanic
1004 Participants1110 Participants926 Participants3040 Participants
Sex: Female, Male
Female
738 Participants710 Participants701 Participants2149 Participants
Sex: Female, Male
Male
828 Participants1033 Participants764 Participants2625 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1,5660 / 1,7430 / 1,465
other
Total, other adverse events
0 / 1,5660 / 1,7430 / 1,465
serious
Total, serious adverse events
0 / 1,5660 / 1,7430 / 1,465

Outcome results

Primary

Statin Prescribing Rate

Percentage of patients eligible for a statin that have been prescribed a statin

Time frame: Two Months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlStatin Prescribing Rate40 Participants
Active ChoiceStatin Prescribing Rate116 Participants
Active Choice With Social Comparison FeedbackStatin Prescribing Rate117 Participants

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026