Nudges for Statin Prescribing in Primary Care

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Behavioral: Patient Nudge; Behavioral: Clinician Nudge

• Registration Number: NCT04307472
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-13
• Study Start: 2020-10-19
• Primary Completion: 2021-04-18
• Study Completion: 2021-04-18
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-20
• Last Update Posted: 2021-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4131

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%

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Patient nudge	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.
Clinician Nudge and Patient Nudge	Clinician Nudge	The clinician nudge and patient nudge will be implemented.
Clinician nudge	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.
Clinician Nudge and Patient Nudge	Patient Nudge	The clinician nudge and patient nudge will be implemented.

Primary Outcome Measures

Name	Time	Method
Statin Prescribing	6 months	Change in percent of patients prescribed a statin medication.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States