Nudges for Statin Prescribing in Primary Care

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04307472
• Other study ID #: 833396
• Secondary ID: 4R33AG057380-03
• Status: Completed
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: April 18, 2021

Study information

• Verified date: May 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4131
• Est. completion date: April 18, 2021
• Est. primary completion date: April 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Clinician Nudge
Active choice intervention in the electronic health record and peer comparison messaging on performance
• Patient Nudge
Text message sent to patients to prompt awareness of statin eligibility before an appointment with their primary care physician

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Statin Prescribing	Change in percent of patients prescribed a statin medication.	6 months