Evaluating the Efficacy of Pediatric Lipid Screening Alerts

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

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:

        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.
    


Study Type

Interventional


Primary Outcome

Lipid Panel Order


Condition

Hypercholesterolemia

Intervention

Best Practice Alert

Study Arms / Comparison Groups

 Passive Control
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

13480

Start Date

October 10, 2019

Completion Date

October 11, 2020

Primary Completion Date

October 11, 2020

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
      

Gender

All

Ages

9 Years - 11 Years

Accepts Healthy Volunteers

No

Contacts

Amir Goren, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04118348

Organization ID

2019-0418


Responsible Party

Principal Investigator

Study Sponsor

Geisinger Clinic


Study Sponsor

Amir Goren, PhD, Principal Investigator, Geisinger Clinic


Verification Date

January 2022