Trial Outcomes & Findings for Computer-Assisted Self-Interviews and Health Screening in the Pediatric Emergency Department (NCT NCT01708317)
NCT ID: NCT01708317
Last Updated: 2013-01-08
Results Overview
The primary outcome was change in the proportion of adolescent patients receiving chlamydia and gonorrhea testing rates during their ED visit over 4 time periods. Period 1) 2010 testing as a historical control Period 2) Jan 2011, began providing staff education about the risks of gonorrhea/chlamydia and need for increased testing Period 3) Education continues, but enrolled patients in the ACASI from April 18, 2011 - Dec 20, 2011. Period 4) ACASI enrollment completed, education continued through March 2012 We specifically analyzed gonorrhea/chlamydia testing among ED patients that would have been eligible to take the ACASI, had it been continuously available throughout these time periods. We did this to isolate the effects on testing by the ACASI vs. education alone.
COMPLETED
NA
801 participants
27 months
2013-01-08
Participant Flow
We monitored overall testing in the ED from Jan 2010 - March 2012, but only actively enrolled patients from April 18, 2011 - Dec 20, 2011. All ACASI participants were patients in the St. Louis Children's Hospital ER.
There was an education lead in before introducing the ACASI, to see if education alone would increase the amount of patients receiving gonorrhea/chlamydia testing. The education started in Jan, 2011 and continued the remainder of the study period.
Participant milestones
| Measure |
ACASI
The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)
ACASI : Youth who participated in this study completed the ACASI -- they provided details about their sexual history, and the software program used their responses to create a recommendation for chlamydia/gonorrhea testing. The information obtained through the ACASI was integrated into the emergency department (ED) electronic medical record. ED physicians and nurses were able to review the information and order chlamydia/gonorrhea testing if needed.
We compared testing over 4 time periods: 2010 (baseline), Jan - April 17, 2011 (education only), April 18-2011 - Dec 20, 2011 (education + enrollment in ACASI), and Dec 21, 2011 - March 31, 2012 (education only, ACASI enrollment stopped.
|
|---|---|
|
2010 Control Period
STARTED
|
3929
|
|
2010 Control Period
COMPLETED
|
3929
|
|
2010 Control Period
NOT COMPLETED
|
0
|
|
Initial Education Period
STARTED
|
982
|
|
Initial Education Period
COMPLETED
|
982
|
|
Initial Education Period
NOT COMPLETED
|
0
|
|
ACASI + Education Period
STARTED
|
2601
|
|
ACASI + Education Period
COMPLETED
|
2601
|
|
ACASI + Education Period
NOT COMPLETED
|
0
|
|
Final Education Period
STARTED
|
909
|
|
Final Education Period
COMPLETED
|
909
|
|
Final Education Period
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Computer-Assisted Self-Interviews and Health Screening in the Pediatric Emergency Department
Baseline characteristics by cohort
| Measure |
ACASI
n=8421 Participants
The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)
ACASI : Youth who participated in this study completed the ACASI -- they provided details about their sexual history, and the software program used their responses to create a recommendation for chlamydia/gonorrhea testing. The information obtained through the ACASI was integrated into the emergency department (ED) electronic medical record. ED physicians and nurses were able to review the information and order chlamydia/gonorrhea testing if needed.
We compared testing over 4 time periods: 2010 (baseline), Jan - April 17, 2011 (education only), April 18-2011 - Dec 20, 2011 (education + enrollment in ACASI), and Dec 21, 2011 - March 31, 2012 (education only, ACASI enrollment stopped.
|
|---|---|
|
Age, Categorical
<=18 years
|
7042 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1379 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age Continuous
|
17.0 years
STANDARD_DEVIATION 1.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4643 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3778 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
8421 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 27 monthsPopulation: We analyzed every patient in this time period that met our ACASI inclusion/exclusion criteria
The primary outcome was change in the proportion of adolescent patients receiving chlamydia and gonorrhea testing rates during their ED visit over 4 time periods. Period 1) 2010 testing as a historical control Period 2) Jan 2011, began providing staff education about the risks of gonorrhea/chlamydia and need for increased testing Period 3) Education continues, but enrolled patients in the ACASI from April 18, 2011 - Dec 20, 2011. Period 4) ACASI enrollment completed, education continued through March 2012 We specifically analyzed gonorrhea/chlamydia testing among ED patients that would have been eligible to take the ACASI, had it been continuously available throughout these time periods. We did this to isolate the effects on testing by the ACASI vs. education alone.
Outcome measures
| Measure |
Historical Control
n=3929 Participants
Participants seen in SLCH ED in 2010 that met ACASI inclusion/exclusion criteria
|
Initial Education Period
n=982 Participants
Participants seen in SLCH ED Jan 1 - April 17 2011 during initial education period that met ACASI inclusion/exclusion criteria
|
ACASI + Education
n=2601 Participants
Participants seen in SLCH ED April 18 - Dec 20 2011 that met ACASI inclusion/exclusion criteria. During this period education continued and ACASI enrollment was conducted.
|
Final Education Period
n=909 Participants
Participants seen in SLCH ED Dec 21, 2011 through March 2012 that met ACASI inclusion/exclusion criteria. During this period education continued and no ACASI enrollment was conducted.
|
|---|---|---|---|---|
|
Gonorrhea and Chlamydia Testing in the Pediatric ED
|
9.7 percentage of participants
|
9.3 percentage of participants
|
17.8 percentage of participants
|
12.4 percentage of participants
|
Adverse Events
ACASI
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Fahd A Ahmad
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place