GonorrheaNCT01708317
Computer-Assisted Self-Interviews and Health Screening in the Pediatric Emergency Department
A study testing ACASI in people with Gonorrhea and Chlamydia, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine if an Audio-enhanced Computer-Assisted Self-Interview (ACASI) will lead to increase testing for sexually transmitted infections in youth visiting a pediatric ED Read more about this study
- Who is it for?
- Ages 15 to 21 years
- What is being tested?
- ACASI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 801 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient in the St. Louis Children's Hospital Emergency Department
- 15-21 years old
Who cannot join
- Evaluation of abuse or sexual assault
- Activation of the trauma system,
- Level 1 or 2 triage scores (highest severity)
- Disabilities preventing independent computer use
- Psychiatric chief complaints
- Inability to speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: The Use of Computer-Assisted Self-Interviews to Improve Adolescent and Young Adult Health Screening in the Pediatric Emergency Department
The purpose of this study is to determine if an Audio-enhanced Computer-Assisted Self-Interview (ACASI) will lead to increase testing for sexually transmitted infections in youth visiting a pediatric ED
Read the detailed description
The purpose of this study is to see if computer based health surveys for teenagers and young adults in the emergency department can improve the care we give, even for things that are not related to why they came to the emergency department.
Topics that are important in this age range include depression, violence, sexual behavior, physical activity and nutrition, though we are not asking about all of these.
WHAT WILL HAPPEN DURING THIS STUDY?
We wish to respect the privacy of everyone takes this survey. In order to do this, we are asking all relatives including your parents or guardians to respect several things so that you may participate:
- We cannot tell family or friends the exact questions on the survey
- You must be given complete privacy to answer the questions
- The answers will only be shown to the healthcare team taking care of them today and the people running the study - family members will not be shown the answers
- Family and friends will not pressure you to discuss the survey or their answers after you are done
- You will be given privacy to discuss their answers with the healthcare team
If you do not feel your friends and family can respect these requests, then you cannot take the survey and cannot enroll in the study.
If you agree to these requests, we will use a private area and allow you to use a computer to do the following:
- Explain in more detail what types of questions we will ask and why they are important
- Tell you how we will use your answers to improve their health care
- Give you a chance to answer any questions you have about the study
- Answer a series of questions about yourself and your health
You are allowed to skip any questions you do not want to answer and can stop at any time.
After you have completed the survey, a summary of your answers will become part of your medical record from today and be shown to the doctors and nurses taking care of you today.
Most participants will be asked to review their answers in private with the doctors and nurses taking care of them. If you do, your family and friends will be asked to step out of the room while you review the answers with the doctors and nurses.
Some participants may have additional testing or services done as part of their visit today based on their answers
- Being tested
- ACASI
- Keywords
- ACASI, Gonorrhea, Chlamydia, Emergency Department, Youth, Adolescents, Computer, Questionnaire
- Medical subject headings
- Gonorrhea, Chlamydia Infections, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACASIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ACASI | Other | The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI) Receives: Behavioral: ACASI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gonorrhea and Chlamydia Testing in the Pediatric ED
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.
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startApr 2011
- Primary completionDec 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for GonorrheaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 801 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- St. Louis Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Fahd A Ahmad, MD, MSCI, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708317
- Sponsor's protocol ID
- 20110243
- Status last verified
- Dec 2012
- First submitted
- 9 Oct 2012
- Last updated
- 8 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Porter SC, Silvia MT, Fleisher GR, Kohane IS, Homer CJ, Mandl KD. Parents as direct contributors to the medical record: validation of their electronic input. Ann Emerg Med. 2000 Apr;35(4):346-52. doi: 10.1016/s0196-0644(00)70052-7.
PubMed 10736120Bachman JW. The patient-computer interview: a neglected tool that can aid the clinician. Mayo Clin Proc. 2003 Jan;78(1):67-78. doi: 10.4065/78.1.67.
PubMed 12528879Porter SC, Mandl KD. Data quality and the electronic medical record: a role for direct parental data entry. Proc AMIA Symp. 1999:354-8.
PubMed 10566380Porter SC, Cai Z, Gribbons W, Goldmann DA, Kohane IS. The asthma kiosk: a patient-centered technology for collaborative decision support in the emergency department. J Am Med Inform Assoc. 2004 Nov-Dec;11(6):458-67. doi: 10.1197/jamia.M1569. Epub 2004 Aug 6.
PubMed 15298999Williams ML, Freeman RC, Bowen AM, Zhao Z, Elwood WN, Gordon C, Young P, Rusek R, Signes CA. A comparison of the reliability of self-reported drug use and sexual behaviors using computer-assisted versus face-to-face interviewing. AIDS Educ Prev. 2000 Jun;12(3):199-213.
PubMed 10926124Kissinger P, Rice J, Farley T, Trim S, Jewitt K, Margavio V, Martin DH. Application of computer-assisted interviews to sexual behavior research. Am J Epidemiol. 1999 May 15;149(10):950-4. doi: 10.1093/oxfordjournals.aje.a009739.
PubMed 10342804Millstein SG, Irwin CE Jr. Acceptability of computer-acquired sexual histories in adolescent girls. J Pediatr. 1983 Nov;103(5):815-9. doi: 10.1016/s0022-3476(83)80493-4.
PubMed 6631616Hewett PC, Mensch BS, Erulkar AS. Consistency in the reporting of sexual behaviour by adolescent girls in Kenya: a comparison of interviewing methods. Sex Transm Infect. 2004 Dec;80 Suppl 2(Suppl 2):ii43-8. doi: 10.1136/sti.2004.013250.
PubMed 15572639
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Computer-Assisted Self-Interviews to Improve Adolescent and Young Adult Health Screening in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT01708317
- Acronym / sponsor ID
- 20110243
- Keywords
- ACASI, Gonorrhea, Chlamydia, Emergency Department, Youth, Adolescents, Computer, Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 801 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- St. Louis Children's Hospital
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Posted 8 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if an Audio-enhanced Computer-Assisted Self-Interview (ACASI) will lead to increase testing for sexually transmitted infections in youth visiting a pediatric ED
Detailed description
The purpose of this study is to see if computer based health surveys for teenagers and young adults in the emergency department can improve the care we give, even for things that are not related to why they came to the emergency department.
Topics that are important in this age range include depression, violence, sexual behavior, physical activity and nutrition, though we are not asking about all of these.
WHAT WILL HAPPEN DURING THIS STUDY?
We wish to respect the privacy of everyone takes this survey. In order to do this, we are asking all relatives including your parents or guardians to respect several things so that you may participate:
- We cannot tell family or friends the exact questions on the survey
- You must be given complete privacy to answer the questions
- The answers will only be shown to the healthcare team taking care of them today and the people running the study - family members will not be shown the answers
- Family and friends will not pressure you to discuss the survey or their answers after you are done
- You will be given privacy to discuss their answers with the healthcare team
If you do not feel your friends and family can respect these requests, then you cannot take the survey and cannot enroll in the study.
If you agree to these requests, we will use a private area and allow you to use a computer to do the following:
- Explain in more detail what types of questions we will ask and why they are important
- Tell you how we will use your answers to improve their health care
- Give you a chance to answer any questions you have about the study
- Answer a series of questions about yourself and your health
You are allowed to skip any questions you do not want to answer and can stop at any time.
After you have completed the survey, a summary of your answers will become part of your medical record from today and be shown to the doctors and nurses taking care of you today.
Most participants will be asked to review their answers in private with the doctors and nurses taking care of them. If you do, your family and friends will be asked to step out of the room while you review the answers with the doctors and nurses.
Some participants may have additional testing or services done as part of their visit today based on their answers
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACASI | Other | Behavioral: ACASIThe group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI) |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patient in the St. Louis Children's Hospital Emergency Department
- 15-21 years old
Key exclusion criteria (6 listed)
- Evaluation of abuse or sexual assault
- Activation of the trauma system,
- Level 1 or 2 triage scores (highest severity)
- Disabilities preventing independent computer use
- Psychiatric chief complaints
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACASIYouth 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. | Behavioural | ACASI |
Primary outcome
Gonorrhea and Chlamydia Testing in the Pediatric ED
Time frame: 27 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10736120Porter SC, Silvia MT, Fleisher GR, Kohane IS, Homer CJ, Mandl KD. Parents as direct contributors to the medical record: validation of their electronic input. Ann Emerg Med. 2000 Apr;35(4):346-52. doi: 10.1016/s0196-0644(00)70052-7.
- Background: PubMed 12528879Bachman JW. The patient-computer interview: a neglected tool that can aid the clinician. Mayo Clin Proc. 2003 Jan;78(1):67-78. doi: 10.4065/78.1.67.
- Background: PubMed 10566380Porter SC, Mandl KD. Data quality and the electronic medical record: a role for direct parental data entry. Proc AMIA Symp. 1999:354-8.
- Background: PubMed 15298999Porter SC, Cai Z, Gribbons W, Goldmann DA, Kohane IS. The asthma kiosk: a patient-centered technology for collaborative decision support in the emergency department. J Am Med Inform Assoc. 2004 Nov-Dec;11(6):458-67. doi: 10.1197/jamia.M1569. Epub 2004 Aug 6.
- Background: PubMed 10926124Williams ML, Freeman RC, Bowen AM, Zhao Z, Elwood WN, Gordon C, Young P, Rusek R, Signes CA. A comparison of the reliability of self-reported drug use and sexual behaviors using computer-assisted versus face-to-face interviewing. AIDS Educ Prev. 2000 Jun;12(3):199-213.
- Background: PubMed 10342804Kissinger P, Rice J, Farley T, Trim S, Jewitt K, Margavio V, Martin DH. Application of computer-assisted interviews to sexual behavior research. Am J Epidemiol. 1999 May 15;149(10):950-4. doi: 10.1093/oxfordjournals.aje.a009739.
- Background: PubMed 6631616Millstein SG, Irwin CE Jr. Acceptability of computer-acquired sexual histories in adolescent girls. J Pediatr. 1983 Nov;103(5):815-9. doi: 10.1016/s0022-3476(83)80493-4.
- Background: PubMed 15572639Hewett PC, Mensch BS, Erulkar AS. Consistency in the reporting of sexual behaviour by adolescent girls in Kenya: a comparison of interviewing methods. Sex Transm Infect. 2004 Dec;80 Suppl 2(Suppl 2):ii43-8. doi: 10.1136/sti.2004.013250.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fahd A Ahmad, MD, MSCI principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACASI in people with Gonorrhea and Chlamydia, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gonorrhea and Chlamydia Testing in the Pediatric ED (time frame: 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01708317, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2013.