Active Choice in the EHR to Promote Statin Therapy

Study Overview
=================
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.

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

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Behavioral: Active choice
* Behavioral: Passive choice


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Cardiologists in this arm will receive no interventions and will act as usual care | |
| Experimental: Active choice<br>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. | Behavioral: Active choice<br>* EHR alert prompting cardiologists to make an active choice to prescribe a statin or not.<br>|
| Experimental: Passive choice<br>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. | Behavioral: Passive choice<br>* EHR passive alert to cardiologists about prescribing a statin<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the percent of eligible patients prescribed statin therapy at a dose that meets evidence-based guidelines | Among patients not on guideline-based statin dosages, the percent that are prescribed guideline-based therapy at appropriate dose. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in percentage of eligible patients prescribed a statin, at any dose. | Among patients not on a statin, the percent that are prescribed guideline-based therapy, at any dose. | 6 Months |