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Evaluating the Efficacy of Pediatric Lipid Screening Alerts

Primary Purpose

Hypercholesterolemia, Hypercholesterolemia, Familial, Hypercholesteremia in Children

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice Alert
Health Maintenance Topic
Sponsored by
Geisinger Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hypercholesterolemia focused on measuring Optimal default, Best practice alert, Health maintenance topic

Eligibility Criteria

9 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • 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

Exclusion criteria:

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

Sites / Locations

  • Geisinger Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Passive Control

Best Practice Alert (BPA-only)

Health Maintenance Topic (HMT-only)

BPA+HMT

Arm Description

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.

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.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 3, 2019
Last Updated
November 11, 2022
Sponsor
Geisinger Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04118348
Brief Title
Evaluating the Efficacy of Pediatric Lipid Screening Alerts
Official Title
Evaluating the Efficacy of Different Electronic Medical Record Alerts to Increase Pediatric Lipid Screening Across a Large Integrated Health System
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
October 11, 2020 (Actual)
Study Completion Date
October 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Geisinger Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patients who are eligible for this study will be randomized into one of four groups via an Epic electronic medical record (EMR) randomization algorithm run automatically at the time of the visit: Control group (6-month delay before their providers will receive an alert) Health maintenance topic (HMT) Best practice alert (BPA) Best practice alert and health maintenance topic (BPA+HMT) Geisinger Health System will introduce Epic's Storyboard panel (a novel way of summarizing patient information in the EMR) approximately one month into this study. The analysis plan will therefore test for the potential impact of this change. The providers will be prompted to discuss and order screening lipid study that is non fasting at the time of the visit with the patient, based on the alerts above. Some families will have an alert in their MyGeisinger portal stating that a health maintenance test is due and to discuss with their provider. Outcomes will be reviewed and classified as followed, Outcomes will include lipid screening orders by providers (yes/no) and screening completions by patients (yes/no). The following descriptive results will also be provided: Lipid screening ordered Lipid screening ordered and completed Lipid screening ordered but not completed Lipid screening declined with reason why Alert not acted on at all Analysis will account for the nesting of patients within providers; this will include provider as a random effects variable in a series of multilevel binomial logistic regression models, to account for potential correlation with patients. If the intraclass correlation coefficient is low, only the patient-level logistic regression models will be conducted. In the first model, the passive control will serve as the reference group, to test whether each of the active alert conditions have a significant impact on the outcomes. In the second model, the BPA-only condition will serve as the reference group, to test whether HMT and BPA+HMT offer significant improvements in performance. Finally, the third model will use the HMT-only condition as the reference, to test whether BPA+HMT has a significantly greater impact on the outcomes. Storyboard X Condition interactions will be tested within the models, and if any are significant, the series of models will be conducted separately on patients prior to, and after, implementation of Storyboard in Epic, to test whether and how results replicate in the different contexts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Hypercholesterolemia, Familial, Hypercholesteremia in Children, Hyperlipidemia in Children
Keywords
Optimal default, Best practice alert, Health maintenance topic

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Prospective randomized controlled trial.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
13480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Passive Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Best Practice Alert (BPA-only)
Arm Type
Experimental
Arm Description
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.
Arm Title
Health Maintenance Topic (HMT-only)
Arm Type
Experimental
Arm Description
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.
Arm Title
BPA+HMT
Arm Type
Experimental
Arm Description
Will consist of both the BPA and HMT presented simultaneously in Epic.
Intervention Type
Behavioral
Intervention Name(s)
Best Practice Alert
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Maintenance Topic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lipid Panel Order
Description
Provider ordered a lipid panel to an eligible patient during the patient's first visit within the study period (binary variable).
Time Frame
1 day
Title
Lipid Panel Screening
Description
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).
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 Exclusion criteria: patients who have completed a lipid screen in the EMR patients who were determined to have familial hypercholesterolemia based on prior screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Goren, PhD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Health System
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
The data on the Open Science Framework will be open to anyone requesting that information.
IPD Sharing URL
http://osf.io

Learn more about this trial

Evaluating the Efficacy of Pediatric Lipid Screening Alerts

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