Trial Outcomes & Findings for The Effect of an Electronic Medical Record (EMR) Alert on Hepatitis B Screening (NCT NCT04240678)
NCT ID: NCT04240678
Last Updated: 2021-08-11
Results Overview
Number of patients who have completed the HBsAg test
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8299 participants
Primary outcome timeframe
up to 12 months
Results posted on
2021-08-11
Participant Flow
Participant milestones
| Measure |
HBV Alert Group
Electronic HBV Alert: Electronic HBV Alert deployed in electronic medical charts of at risk patients
|
Control Group
No alert
|
|---|---|---|
|
Overall Study
STARTED
|
4141
|
4158
|
|
Overall Study
COMPLETED
|
4141
|
4158
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of an Electronic Medical Record (EMR) Alert on Hepatitis B Screening
Baseline characteristics by cohort
| Measure |
HBV Alert Group
n=4 Participants
Electronic HBV Alert: Electronic HBV Alert deployed in electronic medical charts of at risk patients
|
Control Group
n=4 Participants
No Alert
|
Total
n=8299 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4141 Participants
n=99 Participants
|
4158 Participants
n=107 Participants
|
8299 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
51.64 years
STANDARD_DEVIATION 20.88 • n=99 Participants
|
51.32 years
STANDARD_DEVIATION 20.66 • n=107 Participants
|
51.45 years
STANDARD_DEVIATION 20.77 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2,172 Participants
n=99 Participants
|
2,256 Participants
n=107 Participants
|
4428 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1,969 Participants
n=99 Participants
|
1,902 Participants
n=107 Participants
|
3871 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4,141 Participants
n=99 Participants
|
4,158 Participants
n=107 Participants
|
8299 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4,141 Participants
n=99 Participants
|
4,158 Participants
n=107 Participants
|
8299 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4,141 participants
n=99 Participants
|
4,158 participants
n=107 Participants
|
8299 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 12 monthsNumber of patients who have completed the HBsAg test
Outcome measures
| Measure |
HBV Alert Group
n=4 Participants
Electronic HBV Alert: Electronic HBV Alert deployed in electronic medical charts of at risk patients
|
Control Group
n=4 Participants
No alert
|
|---|---|---|
|
Serum Hepatitis B Surface Antigen Completion
|
389 Participants
|
177 Participants
|
SECONDARY outcome
Timeframe: up to 12 monthsNumber of patients with testing positive for HBsAg
Outcome measures
| Measure |
HBV Alert Group
n=4 Participants
Electronic HBV Alert: Electronic HBV Alert deployed in electronic medical charts of at risk patients
|
Control Group
n=4 Participants
No alert
|
|---|---|---|
|
Serum Hepatitis B Surface Antigen Positivity
|
15 Participants
|
13 Participants
|
Adverse Events
HBV Alert Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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