Active Choice in the EHR to Promote Statin Therapy

NCT ID: NCT03271931

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23066 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-24
• Study Completion Date: 2019-06-05

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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Active choice

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.

Group Type: EXPERIMENTAL

Active choice

Intervention Type: BEHAVIORAL

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

Passive choice

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.

Group Type: EXPERIMENTAL

Passive choice

Intervention Type: BEHAVIORAL

EHR passive alert to cardiologists about prescribing a statin

Interventions

Active choice

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

Intervention Type: BEHAVIORAL

Passive choice

EHR passive alert to cardiologists about prescribing a statin

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitesh Patel, MD, MBA, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33031534 (View on PubMed)

Other Identifiers

827983

Identifier Type: -

Identifier Source: org_study_id