Active Choice in the EHR to Promote Statin Therapy

University of Pennsylvania

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Behavioral: Active choice; Behavioral: Passive choice

Study type: Interventional

Funder types: Other

Identifiers

NCT03271931

827983

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 23,066 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23,066 participants in 3 patient groups

Usual care

No Intervention group

Description:

Cardiologists in this arm will receive no interventions and will act as usual care

Active choice

Experimental group

Description:

Cardiologists in this arm will be exposed to an active choice intervention through the electronic health record (EHR) using an alert to prompt recommendations for statin therapy for patients not on guideline-based therapy. Cardiologists will be have to make an active choice to prescribe a statin at the recommended dose or not.

Treatment:

Behavioral: Active choice

Passive choice

Experimental group

Description:

Cardiologists in this arm will be exposed to a passive choice alert within the EHR, using the same evidence-based guidelines as in the active choice arm. 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.

Treatment:

Behavioral: Passive choice