Evaluating the Efficacy of Pediatric Lipid Screening Alerts

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04118348
• Other study ID #: 2019-0418
• Status: Completed
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: October 11, 2020

Study information

• Verified date: October 2023
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13340
• Est. completion date: October 11, 2020
• Est. primary completion date: October 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesteremia in Children
• Hypercholesterolemia
• Hypercholesterolemia, Familial
• Hyperlipidemia in Children
• Hyperlipidemias
• Hyperlipoproteinemia Type II

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Geisinger Health System	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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