Nudges for Statin Prescribing in Primary Care

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT04307472

Collaborator

National Institute on Aging (NIA) (NIH)

4,131

Enrollment

Location

Arms

5.9

Actual Duration (Months)

694.7

Patients Per Site Per Month

Study Details

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	N/A

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

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: Control 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 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 Both clinician nudge and patient nudgesThe four-arm factorial trial will randomly assign primary care practices to one of the following arms for the intervention:Control 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 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 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 :

Oct 19, 2020

Actual Primary Completion Date :

Apr 18, 2021

Actual Study Completion Date :

Apr 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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT04307472

Other Study ID Numbers:

833396
4R33AG057380-03

First Posted:

Mar 13, 2020

Last Update Posted:

May 21, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Pennsylvania

Statin

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of May 21, 2021