Nudges for Statin Prescribing in Primary Care

NCT04307472 | Completed DMC

• 2 other identifiers: 8333964R33AG057380-03
• Study Type: interventional
• Target: 4,131
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

Statin

Outcome Measures

Primary Outcomes (1)

• Statin Prescribing

  Change in percent of patients prescribed a statin medication.

  6 months

Study Arms (4)

Control

NO INTERVENTION

Control arm will receive no intervention.

Clinician nudge

EXPERIMENTAL

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

Patient nudge

EXPERIMENTAL

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

Clinician Nudge and Patient Nudge

EXPERIMENTAL

The clinician nudge and patient nudge will be implemented.

Behavioral: Clinician Nudge; Behavioral: Patient Nudge

Interventions

Clinician Nudge BEHAVIORAL

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

Clinician Nudge and Patient Nudge; Clinician nudge

Patient Nudge BEHAVIORAL

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

Clinician Nudge and Patient Nudge; Patient nudge

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Adusumalli S, Kanter GP, Small DS, Asch DA, Volpp KG, Park SH, Gitelman Y, Do D, Leri D, Rhodes C, VanZandbergen C, Howell JT, Epps M, Cavella AM, Wenger M, Harrington TO, Clark K, Westover JE, Snider CK, Patel MS. Effect of Nudges to Clinicians, Patients, or Both to Increase Statin Prescribing: A Cluster Randomized Clinical Trial. JAMA Cardiol. 2023 Jan 1;8(1):23-30. doi: 10.1001/jamacardio.2022.4373.

  PMID: 36449275 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Mitesh Patel, MD, MBA, MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 13, 2020
• Study Start: October 19, 2020
• Primary Completion: April 18, 2021
• Study Completion: April 18, 2021
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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

Locations

US (1)