Improvement of STI Detection in Adolescent Emergency Department Patients

NCT ID: NCT02509572

Last Updated: 2016-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-06-30

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.

Conditions

Sexually Transmitted Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Decision Support Arm

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.

Group Type: EXPERIMENTAL

Sexual health screen (SHS)

Intervention Type: BEHAVIORAL

Decision support for STI screening through a novel sexual health screen

Usual Care Arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sexual health screen (SHS)

Decision support for STI screening through a novel sexual health screen

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's National Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Monika Goyal

Assistant Professor of Pediatrics & Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monika Goyal, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

CNMC

Locations

Children's National Medical Center

Washington D.C., District of Columbia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28081888 (View on PubMed)

Other Identifiers

00004169

Identifier Type: -

Identifier Source: org_study_id