Hepatitis B
Conditions
Keywords
Mass Screening
Brief summary
Asian and Pacific Islander Americans at risk, but never tested for chronic hepatitis B have been randomized to receive an electronic alert in their electronic medical chart to remind primary care physicians to screen them for chronic hepatitis B.
Interventions
OTHERElectronic HBV Alert
Electronic HBV Alert deployed in electronic medical charts of at risk patients
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Asian and Pacific Islanders (API) who have not yet received HBsAg testing. API will be identified using a novel algorithm which identifies them using their surname, language preference, country of origin. \-
Exclusion criteria
Previous HBsAg completion. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Hepatitis B Surface Antigen Completion | up to 12 months | Number of patients who have completed the HBsAg test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Hepatitis B Surface Antigen Positivity | up to 12 months | Number of patients with testing positive for HBsAg |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HBV Alert Group Electronic HBV Alert: Electronic HBV Alert deployed in electronic medical charts of at risk patients | 4 |
| Control Group No Alert | 4 |
| Total | 8 |
Baseline characteristics
| Characteristic | HBV Alert Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4141 Participants | 4158 Participants | 8299 Participants |
| Age, Continuous | 51.64 years STANDARD_DEVIATION 20.88 | 51.32 years STANDARD_DEVIATION 20.66 | 51.45 years STANDARD_DEVIATION 20.77 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4,141 Participants | 4,158 Participants | 8299 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4,141 Participants | 4,158 Participants | 8299 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 4,141 participants | 4,158 participants | 8299 participants |
| Sex: Female, Male Female | 2,172 Participants | 2,256 Participants | 4428 Participants |
| Sex: Female, Male Male | 1,969 Participants | 1,902 Participants | 3871 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4,141 | 0 / 4,158 |
| other Total, other adverse events | 0 / 4,141 | 0 / 4,158 |
| serious Total, serious adverse events | 0 / 4,141 | 0 / 4,158 |
Outcome results
Primary
Serum Hepatitis B Surface Antigen Completion
Number of patients who have completed the HBsAg test
Time frame: up to 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBV Alert Group | Serum Hepatitis B Surface Antigen Completion | 389 Participants |
| Control Group | Serum Hepatitis B Surface Antigen Completion | 177 Participants |
Secondary
Serum Hepatitis B Surface Antigen Positivity
Number of patients with testing positive for HBsAg
Time frame: up to 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBV Alert Group | Serum Hepatitis B Surface Antigen Positivity | 15 Participants |
| Control Group | Serum Hepatitis B Surface Antigen Positivity | 13 Participants |