Nudges for Statin Prescribing in Primary Care

Study Overview
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Brief Summary
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The objective of the study is to evaluate the effect of nudges to clinicians, patients, or both to initiate statin prescriptions for patients that meet national guidelines.

Detailed Description
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Cardiovascular disease (CVD) is the leading cause of mortality in the United States. Statins have been demonstrated to be an effective tool for reducing the risk of CVD-related events and mortality, but statins are often not prescribed for patients that meet evidence-based guidelines. In this study, the investigators will evaluate nudges to clinicians, patients, or both to initiate statin prescriptions for patients that meet the United States Preventive Task Force guidelines, patients with clinical atherosclerotic cardiovascular disease (ASCVD) condition, and patients with a history of familial hyperlipidemia. In partnership with the health system, this will be conducted as a 4-arm factorial, cluster randomized trial to evaluate the effect of the interventions.

Official Title
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Leveraging the Electronic Health Record to Nudge Clinicians to Prescribe Evidence-Based Statin Medications to Reduce the Risk of Cardiovascular Disease: A Randomized Clinical Trial

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Clinician Nudge
* Behavioral: Patient Nudge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have new or return visit with a primary care provider at one of the study practices at the University of Pennsylvania Health System Either have an ASCVD condition, history of familial hyperlipidemia, or meet United State Preventive Task Force Guidelines for Statin Therapy which includes age 40-75 years, at least 1 cardiovascular risk factor (e.g. dyslipidemia, diabetes, hypertension, smoking), 10-year ASVCD risk score ≥ 10% Exclusion Criteria: Already prescribed a statin 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 statin-related a) myopathy; b) Rhabdomyolysis; c) hepatitis Pregnant Currently breastfeeding on hospice or at the end-of-life On a PCSK9 Inhibitor medication Clinicians (and their respective patients) will be excluded if they have less than 10 patients among their entire panel that are eligible for a statin medication.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: The four-arm factorial trial will randomly assign primary care practices to one of the following arms for the intervention: Control Clinician nudge using an active choice prompt in the electronic health record at the time of the patient visit and a monthly peer comparison message on statin prescribing performance relative to peer clinicians at Penn Medicine delivered through the electronic health record Patient nudge using a text message sent 72 hours prior to their primary care clinician appointment that informs them of their eligibility for a statin, the risks and benefits, and asking them to discuss the role of starting a statin with their clinician Both clinician nudge and patient nudges
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Control arm will receive no intervention. | |
| Experimental: Clinician nudge<br>The clinician nudge using an active choice intervention in the electronic health record will be delivered to the clinician during the patient's visit. This will be through a Best Practice Advisory that describes the guideline criteria for which the patient is eligible for statin therapy, provides pre-selected options for a statin with alternative options. The clinician nudge using monthly peer comparison messages will be sent as an inbox message through the electronic health record. Clinicians will be told what percent of their eligible patients have been prescribed a statin and how that compares to peer clinicians at Penn Medicine. | Behavioral: Clinician Nudge<br>* Active choice intervention in the electronic health record and peer comparison messaging on performance<br>|
| Experimental: Patient nudge<br>The patient nudge will be a text message. Patients with a visit scheduled with their primary care clinician will be identified and sent this text 72 hours before their scheduled visit. The text will remind them of the visit, inform them of their eligibility for a statin, describe the benefits and risks of statin therapy, and ask the patient to discuss statin therapy with their primary care clinician during the visit. | Behavioral: Patient Nudge<br>* Text message sent to patients to prompt awareness of statin eligibility before an appointment with their primary care physician<br>|
| Experimental: Clinician Nudge and Patient Nudge<br>The clinician nudge and patient nudge will be implemented. | Behavioral: Clinician Nudge<br>* Active choice intervention in the electronic health record and peer comparison messaging on performance<br>Behavioral: Patient Nudge<br>* Text message sent to patients to prompt awareness of statin eligibility before an appointment with their primary care physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statin Prescribing | Change in percent of patients prescribed a statin medication. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Statin