Hypercholesteremia in Children, Hypercholesterolemia, Hypercholesterolemia, Familial, Hyperlipidemia in Children
Conditions
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
Study design
Intervention model description
Prospective randomized controlled trial.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lipid Panel Order | 1 day | Provider ordered a lipid panel to an eligible patient during the patient's first visit within the study period (binary variable). |
| Lipid Panel Screening | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 13,340 |
Baseline characteristics
| Characteristic | Health Maintenance Topic (HMT-only) | BPA+HMT | Total | Passive Control | Best Practice Alert (BPA-only) |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 3441 Participants | 3218 Participants | 13340 Participants | 3416 Participants | 3265 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — | — |
| Region of Enrollment United States | 3441 participants | 3218 participants | 13340 participants | 3416 participants | 3265 participants |
| Sex: Female, Male Female | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Passive Control | Lipid Panel Order | 156 Participants |
| Best Practice Alert (BPA-only) | Lipid Panel Order | 454 Participants |
| Health Maintenance Topic (HMT-only) | Lipid Panel Order | 236 Participants |
| BPA+HMT | Lipid Panel Order | 494 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Passive Control | Lipid Panel Screening | 47 Participants |
| Best Practice Alert (BPA-only) | Lipid Panel Screening | 98 Participants |
| Health Maintenance Topic (HMT-only) | Lipid Panel Screening | 70 Participants |
| BPA+HMT | Lipid Panel Screening | 120 Participants |