Trial Outcomes & Findings for High-risk Influenza Vaccine Alert (NCT NCT05492786)
NCT ID: NCT05492786
Last Updated: 2024-12-30
Results Overview
Patient received a flu vaccine (yes/no)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80452 participants
Primary outcome timeframe
At the 1 day visit
Results posted on
2024-12-30
Participant Flow
Participant milestones
| Measure |
Standard Alert
Standard flu alert
Alert: Non-interruptive best practice alert in the electronic health record
|
High-risk Alert
Flu alert that indicates patient is at high risk for flu and its complications
Alert: Non-interruptive best practice alert in the electronic health record
Salient alert features: Larger alert header and body font size, use of different font colors and boldface
High-risk Text: Alert header indicates patient is at high risk for flu and its complications; alert body indicates the percentage of risk (e.g., in the top 3% of risk)
|
High-risk Alert With Risk Factors
Flu alert that indicates patient is at high risk for flu and its complications and presents the factors contributing to this high risk
Alert: Non-interruptive best practice alert in the electronic health record
Salient alert features: Larger alert header and body font size, use of different font colors and boldface
High-risk Text: Alert header indicates patient is at high risk for flu and its complications; alert body indicates the percentage of risk (e.g., in the top 3% of risk)
Risk factors: Alert body indicates the top 3 factors contributing to the high risk
|
Clinicians
Geisinger clinician who saw patient-participants in our study for an appointment where their flu shot alert fires
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24835
|
24854
|
24912
|
5851
|
|
Overall Study
COMPLETED
|
24835
|
24854
|
24912
|
5851
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High-risk Influenza Vaccine Alert
Baseline characteristics by cohort
| Measure |
Standard Alert
n=24835 Participants
Standard flu alert
Alert: Non-interruptive best practice alert in the electronic health record
|
High-risk Alert
n=24854 Participants
Flu alert that indicates patient is at high risk for flu and its complications
Alert: Non-interruptive best practice alert in the electronic health record
Salient alert features: Larger alert header and body font size, use of different font colors and boldface
High-risk Text: Alert header indicates patient is at high risk for flu and its complications; alert body indicates the percentage of risk (e.g., in the top 3% of risk)
|
High-risk Alert With Risk Factors
n=24912 Participants
Flu alert that indicates patient is at high risk for flu and its complications and presents the factors contributing to this high risk
Alert: Non-interruptive best practice alert in the electronic health record
Salient alert features: Larger alert header and body font size, use of different font colors and boldface
High-risk Text: Alert header indicates patient is at high risk for flu and its complications; alert body indicates the percentage of risk (e.g., in the top 3% of risk)
Risk factors: Alert body indicates the top 3 factors contributing to the high risk
|
Clinicians
n=5851 Participants
Geisinger clinician who saw patient-participants in our study for an appointment where their flu shot alert fires
|
Total
n=80452 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
>=18 and <65
|
15945 Participants
n=5 Participants
|
15783 Participants
n=7 Participants
|
15936 Participants
n=5 Participants
|
5254 Participants
n=4 Participants
|
52918 Participants
n=21 Participants
|
|
Age, Customized
>65
|
8890 Participants
n=5 Participants
|
9071 Participants
n=7 Participants
|
8976 Participants
n=5 Participants
|
300 Participants
n=4 Participants
|
27237 Participants
n=21 Participants
|
|
Age, Customized
Unknown or not reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
297 Participants
n=4 Participants
|
297 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Female
|
16334 Participants
n=5 Participants
|
16445 Participants
n=7 Participants
|
16368 Participants
n=5 Participants
|
4224 Participants
n=4 Participants
|
53371 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Male
|
8501 Participants
n=5 Participants
|
8409 Participants
n=7 Participants
|
8544 Participants
n=5 Participants
|
1322 Participants
n=4 Participants
|
26776 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Unknown or not reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
305 Participants
n=4 Participants
|
305 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1108 Participants
n=5 Participants
|
1201 Participants
n=7 Participants
|
1160 Participants
n=5 Participants
|
165 Participants
n=4 Participants
|
3634 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23571 Participants
n=5 Participants
|
23503 Participants
n=7 Participants
|
23605 Participants
n=5 Participants
|
5276 Participants
n=4 Participants
|
75955 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
156 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
410 Participants
n=4 Participants
|
863 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
55 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
177 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
68 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
397 Participants
n=4 Participants
|
620 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
71 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
235 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
871 Participants
n=5 Participants
|
837 Participants
n=7 Participants
|
919 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
2756 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
23613 Participants
n=5 Participants
|
23651 Participants
n=7 Participants
|
23589 Participants
n=5 Participants
|
4686 Participants
n=4 Participants
|
75539 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Two or More
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or Not Reported
|
142 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
575 Participants
n=4 Participants
|
1018 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
24835 participants
n=5 Participants
|
24854 participants
n=7 Participants
|
24912 participants
n=5 Participants
|
5851 participants
n=4 Participants
|
80452 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At the 1 day visitPopulation: As preregistered, our primary outcome analysis is limited to the first in-person appointment for each patient enrolled in the study. Therefore, this analysis excludes the patients who only attended telehealth appointments during the study.
Patient received a flu vaccine (yes/no)
Outcome measures
| Measure |
Standard Alert
n=24257 Participants
Standard flu alert
Alert: Non-interruptive best practice alert in the electronic health record
|
High-risk Alert
n=24262 Participants
Flu alert that indicates patient is at high risk for flu and its complications
Alert: Non-interruptive best practice alert in the electronic health record
Salient alert features: Larger alert header and body font size, use of different font colors and boldface
High-risk Text: Alert header indicates patient is at high risk for flu and its complications; alert body indicates the percentage of risk (e.g., in the top 3% of risk)
|
High-risk Alert With Risk Factors
n=24344 Participants
Flu alert that indicates patient is at high risk for flu and its complications and presents the factors contributing to this high risk
Alert: Non-interruptive best practice alert in the electronic health record
Salient alert features: Larger alert header and body font size, use of different font colors and boldface
High-risk Text: Alert header indicates patient is at high risk for flu and its complications; alert body indicates the percentage of risk (e.g., in the top 3% of risk)
Risk factors: Alert body indicates the top 3 factors contributing to the high risk
|
|---|---|---|---|
|
Flu Vaccination
|
4459 Participants
|
4456 Participants
|
4575 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 8 monthsPatient received a flu diagnosis via a positive polymerase chain reaction \[PCR\]/antigen/molecular test (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 8 monthsReceived a "high confidence flu" diagnosis (with positive polymerase chain reaction \[PCR\]/antigen/molecular test) and/or "likely flu" diagnosis (as assessed via International Classification of Disease \[ICD\] codes or Tamiflu administration or positive PCR/antigen/molecular test) (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023) Note that "likely flu" is a superset of the "high confidence flu" diagnoses.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 8 monthsDiagnosed with flu-related complications (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 11 monthsNumber of ER visits from the patient's message appointment date through July 31, 2023
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 11 monthsNumber of hospitalizations from the patient's message appointment date through July 31, 2023
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 8 monthsReceived at least one COVID-19 vaccination (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 8 monthsPatient receives a flu vaccine (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the 1 day visitPopulation: As preregistered, our primary outcome analysis is limited to the first in-person appointment for each patient enrolled in the study. Therefore, this analysis excludes the patients who only attended telehealth appointments during the study.
Patient received a flu vaccine (yes/no)
Outcome measures
| Measure |
Standard Alert
n=24257 Participants
Standard flu alert
Alert: Non-interruptive best practice alert in the electronic health record
|
High-risk Alert
n=24262 Participants
Flu alert that indicates patient is at high risk for flu and its complications
Alert: Non-interruptive best practice alert in the electronic health record
Salient alert features: Larger alert header and body font size, use of different font colors and boldface
High-risk Text: Alert header indicates patient is at high risk for flu and its complications; alert body indicates the percentage of risk (e.g., in the top 3% of risk)
|
High-risk Alert With Risk Factors
n=24344 Participants
Flu alert that indicates patient is at high risk for flu and its complications and presents the factors contributing to this high risk
Alert: Non-interruptive best practice alert in the electronic health record
Salient alert features: Larger alert header and body font size, use of different font colors and boldface
High-risk Text: Alert header indicates patient is at high risk for flu and its complications; alert body indicates the percentage of risk (e.g., in the top 3% of risk)
Risk factors: Alert body indicates the top 3 factors contributing to the high risk
|
|---|---|---|---|
|
Flu Vaccination by Sex
Female
|
2817 Participants
|
2766 Participants
|
2894 Participants
|
|
Flu Vaccination by Sex
Male
|
1642 Participants
|
1690 Participants
|
1681 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the 1 day visitPopulation: As preregistered, our primary outcome analysis is limited to the first in-person appointment for each patient enrolled in the study. Therefore, this analysis excludes the patients who only attended telehealth appointments during the study.
Patient received a flu vaccine (yes/no)
Outcome measures
| Measure |
Standard Alert
n=24257 Participants
Standard flu alert
Alert: Non-interruptive best practice alert in the electronic health record
|
High-risk Alert
n=24262 Participants
Flu alert that indicates patient is at high risk for flu and its complications
Alert: Non-interruptive best practice alert in the electronic health record
Salient alert features: Larger alert header and body font size, use of different font colors and boldface
High-risk Text: Alert header indicates patient is at high risk for flu and its complications; alert body indicates the percentage of risk (e.g., in the top 3% of risk)
|
High-risk Alert With Risk Factors
n=24344 Participants
Flu alert that indicates patient is at high risk for flu and its complications and presents the factors contributing to this high risk
Alert: Non-interruptive best practice alert in the electronic health record
Salient alert features: Larger alert header and body font size, use of different font colors and boldface
High-risk Text: Alert header indicates patient is at high risk for flu and its complications; alert body indicates the percentage of risk (e.g., in the top 3% of risk)
Risk factors: Alert body indicates the top 3 factors contributing to the high risk
|
|---|---|---|---|
|
Flu Vaccination by Race
White
|
4302 Participants
|
4306 Participants
|
4372 Participants
|
|
Flu Vaccination by Race
Two or More
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Flu Vaccination by Race
American Indian or Alaska Native
|
11 Participants
|
5 Participants
|
9 Participants
|
|
Flu Vaccination by Race
Asian
|
15 Participants
|
20 Participants
|
21 Participants
|
|
Flu Vaccination by Race
Native Hawaiian or Other Pacific Islander
|
10 Participants
|
12 Participants
|
17 Participants
|
|
Flu Vaccination by Race
Black or African American
|
94 Participants
|
90 Participants
|
125 Participants
|
|
Flu Vaccination by Race
Other
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Flu Vaccination by Race
Unknown or Not Reported
|
24 Participants
|
19 Participants
|
26 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the 1 day visitPopulation: As preregistered, our primary outcome analysis is limited to the first in-person appointment for each patient enrolled in the study. Therefore, this analysis excludes the patients who only attended telehealth appointments during the study.
Patient received a flu vaccine (yes/no)
Outcome measures
| Measure |
Standard Alert
n=24257 Participants
Standard flu alert
Alert: Non-interruptive best practice alert in the electronic health record
|
High-risk Alert
n=24262 Participants
Flu alert that indicates patient is at high risk for flu and its complications
Alert: Non-interruptive best practice alert in the electronic health record
Salient alert features: Larger alert header and body font size, use of different font colors and boldface
High-risk Text: Alert header indicates patient is at high risk for flu and its complications; alert body indicates the percentage of risk (e.g., in the top 3% of risk)
|
High-risk Alert With Risk Factors
n=24344 Participants
Flu alert that indicates patient is at high risk for flu and its complications and presents the factors contributing to this high risk
Alert: Non-interruptive best practice alert in the electronic health record
Salient alert features: Larger alert header and body font size, use of different font colors and boldface
High-risk Text: Alert header indicates patient is at high risk for flu and its complications; alert body indicates the percentage of risk (e.g., in the top 3% of risk)
Risk factors: Alert body indicates the top 3 factors contributing to the high risk
|
|---|---|---|---|
|
Flu Vaccination by Ethnicity
Hispanic or Latino
|
164 Participants
|
184 Participants
|
172 Participants
|
|
Flu Vaccination by Ethnicity
Not Hispanic or Latino
|
4278 Participants
|
4244 Participants
|
4377 Participants
|
|
Flu Vaccination by Ethnicity
Unknown or Not Reported
|
17 Participants
|
28 Participants
|
26 Participants
|
Adverse Events
Standard Alert
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High-risk Alert
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High-risk Alert With Risk Factors
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