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Evaluating the Efficacy of Pediatric Lipid Screening Alerts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04118348
Recruitment Status : Not yet recruiting
First Posted : October 8, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Amir Goren, Geisinger Clinic

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Hypercholesterolemia, Familial Hypercholesteremia in Children Hyperlipidemia in Children Behavioral: Best Practice Alert Behavioral: Health Maintenance Topic Not Applicable

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:

  1. Control group (6-month delay before their providers will receive an alert)
  2. Health maintenance topic (HMT)
  3. Best practice alert (BPA)
  4. 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:

  1. Lipid screening ordered
  2. Lipid screening ordered and completed
  3. Lipid screening ordered but not completed
  4. Lipid screening declined with reason why
  5. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Prospective randomized controlled trial.
Masking: Double (Participant, Care Provider)
Primary Purpose: Screening
Official Title: Evaluating the Efficacy of Different Electronic Medical Record Alerts to Increase Pediatric Lipid Screening Across a Large Integrated Health System
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
No Intervention: Passive Control
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.
Experimental: Best Practice Alert (BPA-only)
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
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.

Experimental: Health Maintenance Topic (HMT-only)
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
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.

Experimental: BPA+HMT
Will consist of both the BPA and HMT presented simultaneously in Epic.
Behavioral: Best Practice Alert
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.

Behavioral: Health Maintenance Topic
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 Measures :
  1. Rate of lipid panel prescription [ Time Frame: 6 months ]
    Provider prescribes or does not prescribe a lipid panel to an eligible patient during the patient's first visit within the study time frame.

  2. Rate of lipid panel screening [ Time Frame: 6 months ]
    Patient undergoes or does not undergo the prescribed lipid panel screening within seven days of the patient's first visit within the study time frame.



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118348


Contacts
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Contact: Amir Goren, PhD 570-214-4395 agoren@geisinger.edu
Contact: Thomas W Davis, MD 570-271-6211 twdavis@geisinger.edu

Locations
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United States, Pennsylvania
Geisinger Health System
Danville, Pennsylvania, United States, 17822
Contact: Amir Goren, PhD         
Sponsors and Collaborators
Geisinger Clinic
Investigators
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Principal Investigator: Amir Goren, PhD Geisinger Clinic

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Responsible Party: Amir Goren, Program Director, Behavioral Insights Team, Geisinger Clinic
ClinicalTrials.gov Identifier: NCT04118348    
Other Study ID Numbers: 2019-0418
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: 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.
URL: http://osf.io

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amir Goren, Geisinger Clinic:
Optimal default
Best practice alert
Health maintenance topic
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hyperlipoproteinemias
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn