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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01708317
Recruitment Status : Completed
First Posted : October 16, 2012
Results First Posted : January 8, 2013
Last Update Posted : January 8, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Gonorrhea Chlamydia Behavioral: ACASI

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 801 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Use of Computer-Assisted Self-Interviews to Improve Adolescent and Young Adult Health Screening in the Pediatric Emergency Department
Study Start Date : April 2011
Primary Completion Date : December 2011
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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.



Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708317


Locations
United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
St. Louis Children's Hospital
Investigators
Principal Investigator: Fahd A Ahmad, MD, MSCI Washington University School of Medicine
More Information

Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01708317     History of Changes
Other Study ID Numbers: 20110243
First Posted: October 16, 2012    Key Record Dates
Results First Posted: January 8, 2013
Last Update Posted: January 8, 2013
Last Verified: December 2012

Keywords provided by Washington University School of Medicine:
ACASI
Gonorrhea
Chlamydia
Emergency Department
Youth
Adolescents
Computer
Questionnaire

Additional relevant MeSH terms:
Emergencies
Chlamydia Infections
Gonorrhea
Disease Attributes
Pathologic Processes
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections