NCT04118348

Brief Summary

The purpose of the study is to evaluate prospectively the impact of different system alerts on the prescription of lipid panels to pediatric Geisinger patients (9-11 years old), as per the now-universal guidelines. This will help quantify the relative effectiveness of different alerts and combinations of alerts on provider prescribing behavior and patient uptake of screening.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13,340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

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

October 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

October 10, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2020

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 14, 2022

Completed
Last Updated

November 7, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 3, 2019

Results QC Date

October 12, 2021

Last Update Submit

October 19, 2023

Conditions

Keywords

Optimal defaultBest practice alertHealth maintenance topic

Outcome Measures

Primary Outcomes (2)

  • Lipid Panel Order

    Provider ordered a lipid panel to an eligible patient during the patient's first visit within the study period (binary variable).

    1 day

  • Lipid Panel Screening

    Patient completed a lipid panel screening within seven days of the patient's first visit (binary variable). This screening is not linked to any order made at the patient's first visit (i.e., Outcome Measure 1).

    1 week

Study Arms (4)

Passive Control

NO INTERVENTION

Will consist of no alerts and will serve to examine lipid panel screening rates given the current standard of care. After 6 months, providers in this (and other conditions) will receive the alert(s) with the best demonstrated success in increasing screening rates.

Best Practice Alert (BPA-only)

EXPERIMENTAL

Will consist of a BPA that fires for providers during a visit with an eligible 9-11 year-old patient. This is an active opt-in alert wherein the provider must respond, either confirming the prescription of a lipid panel or opting out with an acknowledgment/reason for declining the test. The BPA will include a recommendation to administer the screen in combination with existing scheduled bloodwork.

Behavioral: Best Practice Alert

Health Maintenance Topic (HMT-only)

EXPERIMENTAL

Will consist of an HMT in Epic that is present for providers at their visit with an eligible patient. The HMT will be highlighted for enhanced visibility, until or unless action is taken.

Behavioral: Health Maintenance Topic

BPA+HMT

EXPERIMENTAL

Will consist of both the BPA and HMT presented simultaneously in Epic.

Behavioral: Best Practice AlertBehavioral: Health Maintenance Topic

Interventions

An Epic screen pops up for a provider during an eligible 9-11 year-old patient's visit. A prompt requires that the provider respond, either confirming the prescription of a lipid panel or opting out with an acknowledgment/reason for declining the test.

BPA+HMTBest Practice Alert (BPA-only)

An Epic health maintenance topic appears for a provider during an eligible 9-11 year-old patient's visit. The HMT will be highlighted for enhanced visibility, until or unless action is taken.

BPA+HMTHealth Maintenance Topic (HMT-only)

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • male or female patients between the ages of 9 - 11
  • seen within a primary care, cardiology, endocrinology, urgent care (CareWorks), or nutrition clinic at Geisinger

You may not qualify if:

  • patients who have completed a lipid screen in the EMR
  • patients who were determined to have familial hypercholesterolemia based on prior screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

Related Publications (1)

  • Goren A, Santos HC, Davis TW, Lowe RB, Monfette M, Meyer MN, Chabris CF. Comparison of Clinical Decision Support Tools to Improve Pediatric Lipid Screening. J Pediatr. 2024 Jun;269:113973. doi: 10.1016/j.jpeds.2024.113973. Epub 2024 Feb 22.

MeSH Terms

Conditions

HypercholesterolemiaHyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemias

Limitations and Caveats

The description of the outcome measures was revised to be more accurate. The analysis plan was also modified from the plan outlined in the study description to include corrections for multiple comparisons (i.e., Tukey correction). Due to limited data access, only information about the orders and completions were given to the researchers. As a result, demographic data and data on adverse effects were not gathered.

Results Point of Contact

Title
Amir Goren, PhD
Organization
Geisinger Clinic

Study Officials

  • Amir Goren, PhD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SCREENING
Intervention Model
FACTORIAL
Model Details: Prospective randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director, Behavioral Insights Team

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 8, 2019

Study Start

October 10, 2019

Primary Completion

October 11, 2020

Study Completion

October 11, 2020

Last Updated

November 7, 2023

Results First Posted

January 14, 2022

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings.

Shared Documents
STUDY PROTOCOL
Time Frame
The data will become available after publication of study results in a scientific journal and will be available as long as the Open Science Framework hosts the data.
Access Criteria
The data on the Open Science Framework will be open to anyone requesting that information.
More information

Locations