Improvement of STI Detection in Adolescent Emergency Department Patients

Not Applicable

Completed

• Conditions: Sexually Transmitted Infections
• Interventions: Behavioral: Sexual health screen (SHS)

• Registration Number: NCT02509572
• Lead Sponsor: Children's National Research Institute

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-07-21
• Study First Submitted QC: 2015-07-27
• Study First Posted: 2015-07-28
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-06
• Last Update Posted: 2016-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 720

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decision Support Arm	Sexual health screen (SHS)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The proportion of adolescents who test positive for an STI in the intervention group in comparison to the usual care group.	Baseline

Trial Locations

Locations (1)

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States