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

Primary Purpose

Gonorrhea, Chlamydia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACASI
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Gonorrhea focused on measuring ACASI, Gonorrhea, Chlamydia, Emergency Department, Youth, Adolescents, Computer, Questionnaire

Eligibility Criteria

15 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Louis Children's Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ACASI

Arm Description

The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 9, 2012
Last Updated
December 4, 2012
Sponsor
Washington University School of Medicine
Collaborators
St. Louis Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01708317
Brief Title
Computer-Assisted Self-Interviews and Health Screening in the Pediatric Emergency Department
Official Title
The Use of Computer-Assisted Self-Interviews to Improve Adolescent and Young Adult Health Screening in the Pediatric Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
St. Louis Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gonorrhea, Chlamydia
Keywords
ACASI, Gonorrhea, Chlamydia, Emergency Department, Youth, Adolescents, Computer, Questionnaire

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
801 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACASI
Arm Type
Other
Arm Description
The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)
Intervention Type
Behavioral
Intervention Name(s)
ACASI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gonorrhea and Chlamydia Testing in the Pediatric ED
Description
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.
Time Frame
27 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fahd A Ahmad, MD, MSCI
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Louis Children's Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10736120
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. doi: 10.1016/s0196-0644(00)70052-7.
Results Reference
background
PubMed Identifier
12528879
Citation
Bachman 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.
Results Reference
background
PubMed Identifier
10566380
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.
Results Reference
background
PubMed Identifier
15298999
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. doi: 10.1197/jamia.M1569. Epub 2004 Aug 6.
Results Reference
background
PubMed Identifier
10926124
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.
Results Reference
background
PubMed Identifier
10342804
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. doi: 10.1093/oxfordjournals.aje.a009739.
Results Reference
background
PubMed Identifier
6631616
Citation
Millstein 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.
Results Reference
background
PubMed Identifier
15572639
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(Suppl 2):ii43-8. doi: 10.1136/sti.2004.013250.
Results Reference
background

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

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