Trial Outcomes & Findings for Evaluating the Efficacy of Pediatric Lipid Screening Alerts (NCT NCT04118348)
NCT ID: NCT04118348
Last Updated: 2023-11-07
Results Overview
Provider ordered a lipid panel to an eligible patient during the patient's first visit within the study period (binary variable).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13340 participants
Primary outcome timeframe
1 day
Results posted on
2023-11-07
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3416
|
3265
|
3441
|
3218
|
|
Overall Study
COMPLETED
|
3416
|
3265
|
3441
|
3218
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Passive Control
n=3416 Participants
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)
n=3265 Participants
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)
n=3441 Participants
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
n=3218 Participants
Will consist of both the BPA and HMT presented simultaneously in Epic.
|
Total
n=13340 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
3416 Participants
n=3416 Participants
|
3265 Participants
n=3265 Participants
|
3441 Participants
n=3441 Participants
|
3218 Participants
n=3218 Participants
|
13340 Participants
n=13340 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=3416 Participants
|
0 Participants
n=3265 Participants
|
0 Participants
n=3441 Participants
|
0 Participants
n=3218 Participants
|
0 Participants
n=13340 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3416 Participants
|
0 Participants
n=3265 Participants
|
0 Participants
n=3441 Participants
|
0 Participants
n=3218 Participants
|
0 Participants
n=13340 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=3416 Participants
|
NA Participants
n=3265 Participants
|
NA Participants
n=3441 Participants
|
NA Participants
n=3218 Participants
|
NA Participants
n=13340 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=3416 Participants
|
NA Participants
n=3265 Participants
|
NA Participants
n=3441 Participants
|
NA Participants
n=3218 Participants
|
NA Participants
n=13340 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3416 participants
n=3416 Participants
|
3265 participants
n=3265 Participants
|
3441 participants
n=3441 Participants
|
3218 participants
n=3218 Participants
|
13340 participants
n=13340 Participants
|
PRIMARY outcome
Timeframe: 1 dayProvider ordered a lipid panel to an eligible patient during the patient's first visit within the study period (binary variable).
Outcome measures
| Measure |
Passive Control
n=3416 Participants
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)
n=3265 Participants
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)
n=3441 Participants
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
n=3218 Participants
Will consist of both the BPA and HMT presented simultaneously in Epic.
|
|---|---|---|---|---|
|
Lipid Panel Order
|
156 Participants
|
454 Participants
|
236 Participants
|
494 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: 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.
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).
Outcome measures
| Measure |
Passive Control
n=3416 Participants
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)
n=3265 Participants
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)
n=3441 Participants
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
n=3265 Participants
Will consist of both the BPA and HMT presented simultaneously in Epic.
|
|---|---|---|---|---|
|
Lipid Panel Screening
|
47 Participants
|
98 Participants
|
70 Participants
|
120 Participants
|
Adverse Events
Passive Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Best Practice Alert (BPA-only)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Maintenance Topic (HMT-only)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BPA+HMT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place