Nudges for Statin Prescribing in Primary Care

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: Clinician Nudge; Behavioral: Patient Nudge

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 4131
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Have new or return visit with a primary care provider at one of the study practices at the University of Pennsylvania Health System
2. 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:

1. Already prescribed a statin
2. Allergy to statins
3. Severe renal insufficiency defined as glomerular filtration rate (GFR) less than 30 mL/min or on dialysis
4. Adverse reaction to statins including statin-related a) myopathy; b) Rhabdomyolysis; c) hepatitis
5. Pregnant
6. Currently breastfeeding
7. on hospice or at the end-of-life
8. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Control arm will receive no intervention.
Experimental: Clinician nudge; 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; Active choice intervention in the electronic health record and peer comparison messaging on performance
Experimental: Patient nudge; 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; Text message sent to patients to prompt awareness of statin eligibility before an appointment with their primary care physician
Experimental: Clinician Nudge and Patient Nudge; The clinician nudge and patient nudge will be implemented.	Behavioral: Clinician Nudge; Active choice intervention in the electronic health record and peer comparison messaging on performance; Behavioral: Patient Nudge; Text message sent to patients to prompt awareness of statin eligibility before an appointment with their primary care physician

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): April 18, 2021
• Study Completion (Actual): April 18, 2021

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Statin
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 833396; 4R33AG057380-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol will be submitted as an appendix to the main manuscript for publication in an academic journal. Changes to the electronic health record to implement the intervention will be described in the main study manuscript. If any coding is required, it will be made accessible to other researchers on Dataverse, an open source web application. After publication of the main findings, analytical codes used to process and analyze the data will be made available to other researchers on Dataverse, an open source web application.
• IPD Sharing Time Frame: Data and datasets will be kept and available to share for at least three years following completion of the project, in accordance with NIH regulations.
• IPD Sharing Access Criteria: Because electronic health record data contains sensitive patient information, it will be made available to external investigators and the public on a case-by-case basis, to be approved by Dr. Patel, in accordance with institutional, HIPAA, state and federal regulations. A data-sharing agreement may be instituted, depending upon the data to be shared. All data that is shared will be de-identified to protect participant privacy and confidentiality
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No