Adolescent Sexually Transmitted Infection Screening in the Emergency Department

Summary

Sexually transmitted infections (STIs) are highly prevalent among adolescents. Clinical practices related to screening, diagnosis, treatment, and prevention of STIs among adolescents are suboptimal. There is a need to expand our screening programs to nontraditional healthcare settings such as emergency departments (ED) and to determine the most efficient and cost-effective method for providing this screening. The goal of this study is to leverage our recent insights obtained from single center ED-based adolescent GC/CT screening research and apply them across a national pediatric ED research network to determine the most clinically effective and cost-effective screening approach for adolescents when implemented into a real-world clinical setting through a pragmatic trial. This will be accomplished through a network of children's hospital EDs with a track record of robust research collaboration (Pediatric Emergency Care Applied Research Network or PECARN). This intervention will rely on an innovative approach that electronically integrates patient-reported data to guide clinical decision support. The investigators will apply human factors modeling methods to perform ED workflow evaluations at each participating pediatric ED to determine the most efficient way to integrate the screening process into clinical care. The investigators will then conduct a comparative effectiveness pragmatic trial of targeted STI screening versus universally offered STI screening through electronic integration of patient reported data for provision of clinical decision support. The investigators will develop decision analytic models to evaluate the cost-effectiveness of targeted screening compared to universally offered screening.

Conditions

• Gonorrhea
• Chlamydia

Interventions

OTHER

Targeted STI Screening

GC/CT screening will be offered to those who screen at risk or at high risk for STIs.

OTHER

Universally Offered STI Screening

GC/CT screening will be offered to all patients who meet the age eligibility criteria.

Sponsors & Collaborators

• MedStar Health

  collaborator OTHER

• Nationwide Children's Hospital

  collaborator OTHER

• Children's National Research Institute

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• Ann & Robert H Lurie Children's Hospital of Chicago

  collaborator OTHER

• Children's Hospital and Health System Foundation, Wisconsin

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Children's Hospital Colorado

  collaborator OTHER

• University of Cincinnati

  collaborator OTHER

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Children's Hospital Medical Center, Cincinnati

  lead OTHER

Principal Investigators

• Jennifer L Reed, MD, MSCE · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

15 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-07-20

Primary Completion

2022-09-25

Completion

2025-07-31

Countries

• United States

Study Locations