Improvement of STI Detection in Adolescent Emergency Department Patients
SHS
1 other identifier
interventional
720
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 21, 2015
CompletedFirst Posted
Study publicly available on registry
July 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 8, 2016
June 1, 2016
1.7 years
July 21, 2015
June 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with difference in frequency of STI testing between the ACASI-SHS group compared to the usual care group.
an expected average of 4-6 hours.
Secondary Outcomes (1)
The proportion of adolescents who test positive for an STI in the intervention group in comparison to the usual care group.
Baseline
Study Arms (2)
Decision Support Arm
EXPERIMENTALPatients 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.
Usual Care Arm
NO INTERVENTIONPatients 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.
Interventions
Decision support for STI screening through a novel sexual health screen
Eligibility Criteria
You may qualify if:
- Aged 14-19 presenting to the emergency department.
You may not qualify if:
- history of developmental delay,
- medical instability,
- altered mental status,
- unable to understand English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Related Publications (1)
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.
PMID: 28081888DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Monika Goyal, MD, MSCE
CNMC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics & Emergency Medicine
Study Record Dates
First Submitted
July 21, 2015
First Posted
July 28, 2015
Study Start
October 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
June 8, 2016
Record last verified: 2016-06