Improvement of STI Detection in Adolescent Emergency Department Patients (SHS)
Primary Purpose
Sexually Transmitted Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sexual health screen (SHS)
Sponsored by
About this trial
This is an interventional screening trial for Sexually Transmitted Infections
Eligibility Criteria
Inclusion Criteria:
- Aged 14-19 presenting to the emergency department.
Exclusion Criteria:
- history of developmental delay,
- medical instability,
- altered mental status,
- unable to understand English
Sites / Locations
- Children's National Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Decision Support Arm
Usual Care Arm
Arm Description
Patients randomized to the intervention will complete a sexual health screen (SHS). The results of the SHS will provide decision support for STI testing by risk stratifying patients with screening recommendations to the clinician based on risk.
Patients randomized to the usual care arm will complete the sexual health screen (SHS). However these results and the STI testing decision support will not be shared with the clinician.
Outcomes
Primary Outcome Measures
Number of Participants with difference in frequency of STI testing between the ACASI-SHS group compared to the usual care group.
Secondary Outcome Measures
The proportion of adolescents who test positive for an STI in the intervention group in comparison to the usual care group.
Full Information
NCT ID
NCT02509572
First Posted
July 21, 2015
Last Updated
June 6, 2016
Sponsor
Children's National Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02509572
Brief Title
Improvement of STI Detection in Adolescent Emergency Department Patients
Acronym
SHS
Official Title
Improvement of STI Detection in Adolescent Emergency Department Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's National Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this trial is to test a novel means of collecting patient-entered sexual health information for the provision of clinical decision support to increase the testing and detection of sexually transmitted infections (STI) in adolescent emergency department (ED) patients at high risk for STIs.
Detailed Description
The investigators have developed a novel means of collecting sexual health information from adolescents in the emergency department (ED) through the use of an audio-computer assisted self-interview (ACASI). This information can then be used to provide clinical decision support to clinicians for targeted sexually transmitted infection (STI) screening in the ED for adolescents. This randomized trial randomizes patients to whether or not the clinician receives the decision support and tests whether provision of decision support results in increased STI screening for patients who report high risk sexual activity. Secondary outcomes include evaluation of whether the clinical decision support results in increased STI detection, and identifying factors associated with adapting the clinical decision support.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Infections
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
720 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Decision Support Arm
Arm Type
Experimental
Arm Description
Patients randomized to the intervention will complete a sexual health screen (SHS). The results of the SHS will provide decision support for STI testing by risk stratifying patients with screening recommendations to the clinician based on risk.
Arm Title
Usual Care Arm
Arm Type
No Intervention
Arm Description
Patients randomized to the usual care arm will complete the sexual health screen (SHS). However these results and the STI testing decision support will not be shared with the clinician.
Intervention Type
Behavioral
Intervention Name(s)
Sexual health screen (SHS)
Intervention Description
Decision support for STI screening through a novel sexual health screen
Primary Outcome Measure Information:
Title
Number of Participants with difference in frequency of STI testing between the ACASI-SHS group compared to the usual care group.
Time Frame
an expected average of 4-6 hours.
Secondary Outcome Measure Information:
Title
The proportion of adolescents who test positive for an STI in the intervention group in comparison to the usual care group.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 14-19 presenting to the emergency department.
Exclusion Criteria:
history of developmental delay,
medical instability,
altered mental status,
unable to understand English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monika Goyal, MD, MSCE
Organizational Affiliation
CNMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28081888
Citation
Goyal MK, Fein JA, Badolato GM, Shea JA, Trent ME, Teach SJ, Zaoutis TE, Chamberlain JM. A Computerized Sexual Health Survey Improves Testing for Sexually Transmitted Infection in a Pediatric Emergency Department. J Pediatr. 2017 Apr;183:147-152.e1. doi: 10.1016/j.jpeds.2016.12.045. Epub 2017 Jan 10.
Results Reference
derived
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Improvement of STI Detection in Adolescent Emergency Department Patients
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