NCT01708317

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
801

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
3 months until next milestone

Results Posted

Study results publicly available

January 8, 2013

Completed
Last Updated

January 8, 2013

Status Verified

December 1, 2012

Enrollment Period

8 months

First QC Date

October 9, 2012

Results QC Date

October 17, 2012

Last Update Submit

December 4, 2012

Conditions

GonorrheaChlamydia

Keywords

ACASIGonorrheaChlamydiaEmergency DepartmentYouthAdolescentsComputerQuestionnaire

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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)

Behavioral: ACASI

Interventions

ACASIBEHAVIORAL

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.

ACASI

Eligibility Criteria

Age15 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (8)

  • 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.

    PMID: 10736120BACKGROUND

  • 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.

    PMID: 12528879BACKGROUND

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

    PMID: 10566380BACKGROUND

  • 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.

    PMID: 15298999BACKGROUND

  • 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.

    PMID: 10926124BACKGROUND

  • 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.

    PMID: 10342804BACKGROUND

  • 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.

    PMID: 6631616BACKGROUND

  • 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.

    PMID: 15572639BACKGROUND

MeSH Terms

Conditions

GonorrheaChlamydia InfectionsEmergencies

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital DiseasesChlamydiaceae InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Fahd A Ahmad
Organization
Washington University School of Medicine
ahmad_f@kids.wustl.edu
314-286-0298

Study Officials

  • Fahd A Ahmad, MD, MSCI

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2012

First Posted

October 16, 2012

Study Start

April 1, 2011

Primary Completion

December 1, 2011

Study Completion

March 1, 2012

Last Updated

January 8, 2013

Results First Posted

January 8, 2013

Record last verified: 2012-12

Locations

US(1)