Clinical trial NCT03271931: Active Choice in the EHR to Promote Statin Therapy
Official title: Using Active Choice in the EHR to Promote Cardiologists to Prescribe Evidence-Based Statin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 23066
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the percent of eligible patients prescribed statin therapy at a dose that meets evidence-based guidelines
timeFrame: 6 Months
Secondary outcomes:
measure: Change in percentage of eligible patients prescribed a statin, at any dose.
timeFrame: 6 Months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Mitesh Patel, MD, MBA, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adusumalli S, Westover JE, Jacoby DS, Small DS, VanZandbergen C, Chen J, Cavella AM, Pepe R, Rareshide CAL, Snider CK, Volpp KG, Asch DA, Patel MS. Effect of Passive Choice and Active Choice Interventions in the Electronic Health Record to Cardiologists on Statin Prescribing: A Cluster Randomized Clinical Trial. JAMA Cardiol. 2021 Jan 1;6(1):40-48. doi: 10.1001/jamacardio.2020.4730.