Computer-Assisted Self-Interviews and Health Screening in the Pediatric Emergency Department

Gonorrhea Clinical Trial

Official title:

The Use of Computer-Assisted Self-Interviews to Improve Adolescent and Young Adult Health Screening in the Pediatric Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708317
• Other study ID #: 20110243
• Status: Completed
• Phase: N/A
• First received: October 9, 2012
• Last updated: December 4, 2012
• Start date: April 2011
• Est. completion date: March 2012

Study information

• Verified date: December 2012
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 801
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 21 Years

Eligibility

Inclusion Criteria:

• Patient in the St. Louis Children's Hospital Emergency Department

• 15-21 years old

Exclusion Criteria:

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Chlamydia
• Emergencies
• Gonorrhea

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	St. Louis Children's Hospital	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	St. Louis Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (8)

Bachman JW. The patient-computer interview: a neglected tool that can aid the clinician. Mayo Clin Proc. 2003 Jan;78(1):67-78. Review. — View Citation

Hewett 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:ii43-8. — View Citation

Kissinger 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. — View Citation

Millstein SG, Irwin CE Jr. Acceptability of computer-acquired sexual histories in adolescent girls. J Pediatr. 1983 Nov;103(5):815-9. — View Citation

Porter 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. Epub 2004 Aug 6. — View Citation

Porter SC, Mandl KD. Data quality and the electronic medical record: a role for direct parental data entry. Proc AMIA Symp. 1999:354-8. — View Citation

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. — View Citation

Williams 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	27 months	No