Cardiovascular Diseases
Conditions
Keywords
Statin
Brief 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.
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.
Interventions
BEHAVIORALClinician Nudge
Active choice intervention in the electronic health record and peer comparison messaging on performance
BEHAVIORALPatient Nudge
Text message sent to patients to prompt awareness of statin eligibility before an appointment with their primary care physician
Sponsors
National Institute on Aging (NIA)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Investigators, statisticians, and analysts will be blinded during the intervention and analysis. Study staff (project director, manager, and research coordinators) will be unblinded throughout the study in order to deliver the appropriate interventions and to manage participant communications. The project manager will be tasked with maintaining codes to associate the blinded assignments to the clinical practices.
Intervention model description
The four-arm factorial trial will randomly assign primary care practices to one of the following arms for the intervention: 1. Control 2. 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 3. 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 4. Both clinician nudge and patient nudges
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Statin Prescribing | 6 months | Change in percent of patients prescribed a statin medication. |
Countries
United States
Outcome results
None listed