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Evaluating the Efficacy of Pediatric Lipid Screening Alerts

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04118348
Enrollment
13340
Registered
2019-10-08
Start date
2019-10-10
Completion date
2020-10-11
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Optimal default, Best practice alert, Health maintenance topic

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.

Interventions

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.

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.

Sponsors

Geisinger Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Caregiver)

Intervention model description

Prospective randomized controlled trial.

Eligibility

Sex/Gender
ALL
Age
9 Years to 11 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Lipid Panel Order1 dayProvider ordered a lipid panel to an eligible patient during the patient's first visit within the study period (binary variable).
Lipid Panel Screening1 weekPatient 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
3,416
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.
3,265
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.
3,441
BPA+HMT
Will consist of both the BPA and HMT presented simultaneously in Epic.
3,218
Total13,340

Baseline characteristics

CharacteristicHealth Maintenance Topic (HMT-only)BPA+HMTTotalPassive ControlBest Practice Alert (BPA-only)
Age, Categorical
<=18 years
3441 Participants3218 Participants13340 Participants3416 Participants3265 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
3441 participants3218 participants13340 participants3416 participants3265 participants
Sex: Female, Male
Female
NA ParticipantsNA ParticipantsNA ParticipantsNA ParticipantsNA Participants
Sex: Female, Male
Male
NA ParticipantsNA ParticipantsNA ParticipantsNA ParticipantsNA Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 0

Outcome results

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).

Time frame: 1 day

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Passive ControlLipid Panel Order156 Participants
Best Practice Alert (BPA-only)Lipid Panel Order454 Participants
Health Maintenance Topic (HMT-only)Lipid Panel Order236 Participants
BPA+HMTLipid Panel Order494 Participants
Comparison: Passive control was set as the reference group.p-value: <0.00195% CI: [4.46, 7.36]Regression, Logistic
Comparison: Passive control was set as the reference group.p-value: <0.00195% CI: [3.79, 6.27]Regression, Logistic
Comparison: Passive control was set as the reference group.p-value: <0.00195% CI: [1.28, 2.19]Regression, Logistic
Comparison: HMT was set as the reference group.p-value: <0.00195% CI: [2.73, 4.29]Regression, Logistic
Comparison: HMT was set as the reference group.p-value: <0.00195% CI: [2.32, 3.66]Regression, Logistic
Comparison: BPA was set as the reference group.p-value: 0.11495% CI: [0.96, 1.43]Regression, Logistic
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).

Time frame: 1 week

Population: We examined all completions made during the time frame, regardless of an order being made at their initial visit. This outcome measure thus covers completions from orders made during the first or any subsequent visit.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Passive ControlLipid Panel Screening47 Participants
Best Practice Alert (BPA-only)Lipid Panel Screening98 Participants
Health Maintenance Topic (HMT-only)Lipid Panel Screening70 Participants
BPA+HMTLipid Panel Screening120 Participants
Comparison: Passive control was set as the reference group.p-value: <0.00195% CI: [2.02, 4.15]Regression, Logistic
Comparison: Passive control was set as the reference group.p-value: <0.00195% CI: [1.57, 3.3]Regression, Logistic
Comparison: Passive control was set as the reference group.p-value: 0.0395% CI: [1.04, 2.27]Regression, Logistic
Comparison: HMT was set as the reference group.p-value: <0.00195% CI: [1.37, 2.59]Regression, Logistic
Comparison: HMT was set as the reference group.p-value: 0.02195% CI: [1.06, 2.06]Regression, Logistic
Comparison: BPA was set as the reference group.p-value: 0.10795% CI: [0.95, 1.71]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026