Evaluating the Efficacy of Pediatric Lipid Screening Alerts
NCT ID: NCT04118348
Last Updated: 2023-11-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
13340 participants
INTERVENTIONAL
2019-10-10
2020-10-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Patient-engaged Development and Testing of Educational Content on Side Effects of Statins
NCT07094412
Translating ATP III Cholesterol Management Guidelines Into Primary Care Practice
NCT01242319
A Family Centered Intervention to Promote Optimal Child Development
NCT01941186
Using Nudges to Implement Comparative Effectiveness
NCT01575171
Active Choice in the EHR to Promote Statin Therapy
NCT03271931
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
SCREENING
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
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.
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 (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.
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.
BPA+HMT
Will consist of both the BPA and HMT presented simultaneously in Epic.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* seen within a primary care, cardiology, endocrinology, urgent care (CareWorks), or nutrition clinic at Geisinger
Exclusion Criteria
* patients who were determined to have familial hypercholesterolemia based on prior screening
9 Years
11 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Geisinger Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Amir Goren
Program Director, Behavioral Insights Team
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Amir Goren, PhD
Role: PRINCIPAL_INVESTIGATOR
Geisinger Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Geisinger Health System
Danville, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-0418
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.