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OpenTrials
Completed

NCT Number: NCT04307472

Nudges for Statin Prescribing in Primary Care

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.

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Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinician Nudge

Behavioral

Active choice intervention in the electronic health record and peer comparison messaging on performance

Patient Nudge

Behavioral

Text message sent to patients to prompt awareness of statin eligibility before an appointment with their primary care physician

Primary outcomes

  1. Statin Prescribing

    Time frame: 6 months

    Change in percent of patients prescribed a statin medication.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 13, 2020
Registry last updated
May 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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