Evaluating the Efficacy of Pediatric Lipid Screening Alerts

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating the Efficacy of Different Electronic Medical Record Alerts to Increase Pediatric Lipid Screening Across a Large Integrated Health System

Conditions
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Hypercholesterolemia, Hypercholesterolemia, Familial, Hypercholesteremia in Children, Hyperlipidemia in Children

Intervention / Treatment
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* Behavioral: Best Practice Alert
* Behavioral: Health Maintenance Topic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Prospective randomized controlled trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Passive Control<br>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)<br>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<br>* 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.<br>|
| Experimental: Health Maintenance Topic (HMT-only)<br>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<br>* 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.<br>|
| Experimental: BPA+HMT<br>Will consist of both the BPA and HMT presented simultaneously in Epic. | Behavioral: Best Practice Alert<br>* 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.<br>Behavioral: Health Maintenance Topic<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Optimal default, Best practice alert, Health maintenance topic