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OpenTrials
Completed

NCT Number: NCT03271931

Active Choice in the EHR to Promote Statin Therapy

Cardiovascular (CV) events are the leading cause of mortality in the United States. Statins have been demonstrated to be an effective tool for reducing CV events and mortality, but statins are often either not prescribed or under-prescribed for patients that meet evidence-based guidelines. In this study, we will evaluate a health system initiative using active and passive choice prompts in the electronic health record to prompt cardiologists to prescribe evidence-based statin therapy. In partnership with the health system, this will be conducted as a randomized, controlled trial to evaluate its effect.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

This study will use a randomized, controlled trial to evaluate a health system initiative. Cardiologists randomly assigned to the control arm will receive no interventions. For cardiologists randomly assigned to the active choice intervention, the electronic health record will be used to prompt cardiologists to initiate or change statin therapy for patients not on evidenced-based guidelines based on the 2013 American College of Cardiology / American Heart Association (ACC/AHA) and the National Lipid Association (NLA) through a "best practice alert" in Epic which appears on the screen and forces a decision before the clinician can move on. For cardiologists randomly assigned to the passive choice intervention, the electronic health record will be used to create a passive alert using the same evidence-based guidelines. The passive alert will not block clinician workflow and instead will be available in the background for the cardiologist to open and then use to make a prescribing decision. The intervention period will be 6 months in duration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have a cardiologist at the University of Pennsylvania Health System
  • Meets 2013 ACC/AHA or NLA guidelines for statin prescription

Exclusion criteria

  • 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 a) myopathy, b)rhabdomyolysis, c)hepatitis
  • Pregnant
  • On a PCSK9 Inhibitor medication

Treatment and study plan

Active choice

Behavioral

EHR alert prompting cardiologists to make an active choice to prescribe a statin or not.

Passive choice

Behavioral

EHR passive alert to cardiologists about prescribing a statin

Primary outcomes

  1. Change in the percent of eligible patients prescribed statin therapy at a dose that meets evidence-based guidelines

    Time frame: 6 Months

    Among patients not on guideline-based statin dosages, the percent that are prescribed guideline-based therapy at appropriate dose.

Secondary outcomes

  1. Change in percentage of eligible patients prescribed a statin, at any dose.

    Time frame: 6 Months

    Among patients not on a statin, the percent that are prescribed guideline-based therapy, at any dose.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Using Active Choice in the EHR to Promote Cardiologists to Prescribe Evidence-Based Statin Therapy

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 5, 2017
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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