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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.
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Passive Control | No Intervention | 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. | |
| Best Practice Alert (BPA-only) | Experimental | 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. |
|
| Health Maintenance Topic (HMT-only) | Experimental | 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. |
|
| BPA+HMT | Experimental | Will consist of both the BPA and HMT presented simultaneously in Epic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amir Goren, PhD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Health System | Danville | Pennsylvania | 17822 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38401785 | Derived | Goren A, Santos HC, Davis TW, Lowe RB, Monfette M, Meyer MN, Chabris CF. Comparison of Clinical Decision Support Tools to Improve Pediatric Lipid Screening. J Pediatr. 2024 Jun;269:113973. doi: 10.1016/j.jpeds.2024.113973. Epub 2024 Feb 22. |
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Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings.
The data will become available after publication of study results in a scientific journal and will be available as long as the Open Science Framework hosts the data.
The data on the Open Science Framework will be open to anyone requesting that information.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. When referring to study arms, BPA refers to participants who triggered BPAs only. |
| FG002 | 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. When referring to study arms, HMT refers to participants who triggered HMTs only. |
| FG003 | BPA+HMT | Will consist of both the BPA and HMT presented simultaneously in Epic. This is a separate group of participants compared to the BPA-only and HMT-only arms. When referring to study arms, BPA+HMT refers to participants who triggered a combination of BPA and HMT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only data related to test orders was pulled for this analysis. No demographic or other baseline data were analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | 1 day |
|
We did not report a time frame as we did not actively collect adverse event data.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. No adverse events were evaluated, as only data from orders and completed tests were gathered. Mortality was not a risk associated with participation in our study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The description of the outcome measures was revised to be more accurate. The analysis plan was also modified from the plan outlined in the study description to include corrections for multiple comparisons (i.e., Tukey correction).
Due to limited data access, only information about the orders and completions were given to the researchers. As a result, demographic data and data on adverse effects were not gathered.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amir Goren, PhD | Geisinger Clinic | 5702144395 | agoren@geisinger.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 19, 2020 | Nov 11, 2022 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 13, 2023 | Oct 13, 2023 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Prospective randomized controlled trial.
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|
| 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. |
|
| 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. |
| BG002 | 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. |
| BG003 | BPA+HMT | Will consist of both the BPA and HMT presented simultaneously in Epic. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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. |
| OG003 | BPA+HMT | Will consist of both the BPA and HMT presented simultaneously in Epic. |
|
|
|
| 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). | 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. | Posted | Count of Participants | Participants | 1 week |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | BPA+HMT | Will consist of both the BPA and HMT presented simultaneously in Epic. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Regression, Logistic |
| <.001 |
| Odds Ratio (OR) |
| 2.28 |
| 2-Sided |
| 95 |
| 1.57 |
| 3.30 |
BPA-only is the numerator |
| Superiority |
| Passive control was set as the reference group. | Regression, Logistic | .030 | Odds Ratio (OR) | 1.54 | 2-Sided | 95 | 1.04 | 2.27 | HMT-only is the numerator | Superiority |
| HMT was set as the reference group. | Regression, Logistic | <.001 | Odds Ratio (OR) | 1.88 | 2-Sided | 95 | 1.37 | 2.59 | BPA+HMT is the numerator | Superiority |
| HMT was set as the reference group. | Regression, Logistic | .021 | Odds Ratio (OR) | 1.48 | 2-Sided | 95 | 1.06 | 2.06 | BPA-only is the numerator | Superiority |
| BPA was set as the reference group. | Regression, Logistic | .107 | Odds Ratio (OR) | 1.27 | 2-Sided | 95 | 0.95 | 1.71 | BPA+HMT is the numerator | Superiority |