NCT03271931

Brief Summary

Cardiovascular (CV) events are the leading cause of mortality in the United States. Statins have been demonstrated to be an effective tool for reducing CV events and mortality, but statins are often either not prescribed or under-prescribed for patients that meet evidence-based guidelines. In this study, we will evaluate a health system initiative using active and passive choice prompts in the electronic health record to prompt cardiologists to prescribe evidence-based statin therapy. In partnership with the health system, this will be conducted as a randomized, controlled trial to evaluate its effect.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23,066

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 24, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

8 months

First QC Date

September 1, 2017

Last Update Submit

July 15, 2019

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Change in the percent of eligible patients prescribed statin therapy at a dose that meets evidence-based guidelines

    Among patients not on guideline-based statin dosages, the percent that are prescribed guideline-based therapy at appropriate dose.

    6 Months

Secondary Outcomes (1)

  • Change in percentage of eligible patients prescribed a statin, at any dose.

    6 Months

Study Arms (3)

Usual care

NO INTERVENTION

Cardiologists in this arm will receive no interventions and will act as usual care

Active choice

EXPERIMENTAL

Cardiologists in this arm will be exposed to an active choice intervention through the electronic health record (EHR) using an alert to prompt recommendations for statin therapy for patients not on guideline-based therapy. Cardiologists will be have to make an active choice to prescribe a statin at the recommended dose or not.

Behavioral: Active choice

Passive choice

EXPERIMENTAL

Cardiologists in this arm will be exposed to a passive choice alert within the EHR, using the same evidence-based guidelines as in the active choice arm. The passive alert will not block clinician workflow and instead will be available in the background for the cardiologist to open and then use to make a prescribing decision.

Behavioral: Passive choice

Interventions

Active choiceBEHAVIORAL

EHR alert prompting cardiologists to make an active choice to prescribe a statin or not.

Active choice
Passive choiceBEHAVIORAL

EHR passive alert to cardiologists about prescribing a statin

Passive choice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a cardiologist at the University of Pennsylvania Health System
  • Meets 2013 ACC/AHA or NLA guidelines for statin prescription

You may not qualify if:

  • 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 a) myopathy, b)rhabdomyolysis, c)hepatitis
  • Pregnant
  • On a PCSK9 Inhibitor medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Adusumalli S, Westover JE, Jacoby DS, Small DS, VanZandbergen C, Chen J, Cavella AM, Pepe R, Rareshide CAL, Snider CK, Volpp KG, Asch DA, Patel MS. Effect of Passive Choice and Active Choice Interventions in the Electronic Health Record to Cardiologists on Statin Prescribing: A Cluster Randomized Clinical Trial. JAMA Cardiol. 2021 Jan 1;6(1):40-48. doi: 10.1001/jamacardio.2020.4730.

    PMID: 33031534DERIVED

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
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2017

First Posted

September 5, 2017

Study Start

September 24, 2018

Primary Completion

June 5, 2019

Study Completion

June 5, 2019

Last Updated

July 16, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)