Nudges for Statin Prescribing in Primary Care

• ClinicalTrials.gov Identifier: NCT04307472
• Recruitment Status: Completed
• First Posted: March 13, 2020
• Last Update Posted: May 21, 2021
• Sponsor: University of Pennsylvania
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): University of Pennsylvania

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Diseases	Behavioral: Clinician Nudge; Behavioral: Patient Nudge	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4131 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment

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

• 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.
• Primary Purpose: Health Services Research
• 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
• Actual Study Start Date: October 19, 2020
• Actual Primary Completion Date: April 18, 2021
• Actual Study Completion Date: April 18, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Statin Prescribing [ Time Frame: 6 months ]
   Change in percent of patients prescribed a statin medication.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Mitesh Patel, MD, MBA, MS; University of Pennsylvania

More Information

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT04307472
• Other Study ID Numbers: 833396; 4R33AG057380-03 ( U.S. NIH Grant/Contract )
• First Posted: March 13, 2020
• Last Update Posted: May 21, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code
• 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.
• 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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Pennsylvania:

Statin

Additional relevant MeSH terms:

Cardiovascular Diseases