HypercholesterolemiaNCT04118348
Evaluating the Efficacy of Pediatric Lipid Screening Alerts
A study testing Best Practice Alert and Health Maintenance Topic in people with Hypercholesterolemia and Hypercholesterolemia, Familial, run by Geisinger Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 9 to 11 years
- Conditions the study is for
- Hypercholesterolemia, Hypercholesterolemia, Familial, Hypercholesteremia in Children
- What is being tested?
- Best Practice Alert and Health Maintenance Topic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,340 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2019to 11 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- patients who have completed a lipid screen in the EMR
- patients who were determined to have familial hypercholesterolemia based on prior screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Health System
Danville, Pennsylvania, 17822
About this study
Official title: Evaluating the Efficacy of Different Electronic Medical Record Alerts to Increase Pediatric Lipid Screening Across a Large Integrated Health System
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.
Read the 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:
- Control group (6-month delay before their providers will receive an alert)
- Health maintenance topic (HMT)
- Best practice alert (BPA)
- 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:
- Lipid screening ordered
- Lipid screening ordered and completed
- Lipid screening ordered but not completed
- Lipid screening declined with reason why
- 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
- Hypercholesterolemia, Hypercholesterolemia, Familial, Hypercholesteremia in Children, Hyperlipidemia in Children
- Being tested
- Best Practice Alert, Health Maintenance Topic
- Keywords
- Optimal default, Best practice alert, Health maintenance topic
- Medical subject headings
- Hypercholesterolemia, Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Practice AlertBehavioural
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 TopicBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Best Practice Alert |
| 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. Receives: Behavioral: Health Maintenance Topic |
| BPA+HMT | Experimental | Will consist of both the BPA and HMT presented simultaneously in Epic. Receives: Behavioral: Best Practice Alert; Behavioral: Health Maintenance Topic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid Panel Order
Provider ordered a lipid panel to an eligible patient during the patient's first visit within the study period (binary variable).
Measured: 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).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start10 Oct 2019
- Primary completion11 Oct 2020
- Study completion11 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Prospective randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 13,340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Goren, Geisinger Clinic
- Investigators
- Amir Goren, PhD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118348
- Sponsor's protocol ID
- 2019-0418
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2019
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38401785
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Different Electronic Medical Record Alerts to Increase Pediatric Lipid Screening Across a Large Integrated Health System
- ClinicalTrials.gov ID
- NCT04118348
- Acronym / sponsor ID
- 2019-0418
- Conditions
- Hypercholesterolemia, Hypercholesterolemia, Familial, Hypercholesteremia in Children, Hyperlipidemia in Children
- Keywords
- Optimal default, Best practice alert, Health maintenance topic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13,340 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 11 Oct 2020 (actual)
- Study completion
- 11 Oct 2020 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Posted 14 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Control group (6-month delay before their providers will receive an alert)
- Health maintenance topic (HMT)
- Best practice alert (BPA)
- 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:
- Lipid screening ordered
- Lipid screening ordered and completed
- Lipid screening ordered but not completed
- Lipid screening declined with reason why
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- Prospective randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Best Practice AlertWill 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 | Behavioral: Health Maintenance TopicWill 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 | Behavioral: Best Practice Alert, Behavioral: Health Maintenance TopicWill consist of both the BPA and HMT presented simultaneously in Epic. |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- patients who have completed a lipid screen in the EMR
- patients who were determined to have familial hypercholesterolemia based on prior screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best Practice AlertAn 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. | Behavioural | BPA+HMT, Best Practice Alert (BPA-only) |
| Health Maintenance TopicAn 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. | Behavioural | BPA+HMT, Health Maintenance Topic (HMT-only) |
Primary outcome
Lipid Panel Order
Time frame: 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
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38401785Goren 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Goren, PhD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice Alert and Health Maintenance Topic in people with Hypercholesterolemia and Hypercholesterolemia, Familial, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid Panel Order (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04118348, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.