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OpenTrials
Completed

NCT Number: NCT04118348

Evaluating the Efficacy of Pediatric Lipid Screening Alerts

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice Alert

Behavioral

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.

Health Maintenance Topic

Behavioral

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 outcomes

  1. Lipid Panel Order

    Time frame: 1 day

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

  2. Lipid Panel Screening

    Time frame: 1 week

    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).

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2019
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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