STI Screening Strategies for Emergency Department Visitors
(STI Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byJennifer L Reed, MD, MSCE

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Children's Hospital Medical Center, Cincinnati

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adolescents aged 15-21 who visit the emergency department and can understand English. They must be able to consent to a sexual health screen and STI testing. Those with cognitive impairments, altered mental status, or critical illness cannot participate.

Inclusion Criteria

I am between 15 and 21 years old.

Exclusion Criteria

Unable to provide consent for completion of the sexual health screen and STI screening.

I have issues with my memory or thinking clearly.

I cannot understand English.

+1 more

Participant Groups

The study tests two methods of screening for sexually transmitted infections (STIs) in emergency departments: one that targets teens reporting high-risk behavior, and another that offers screening to all teens. The goal is to find the most effective and cost-efficient approach.

3Treatment groups

Active Control

Group I: Universally Offered STI ScreeningActive Control1 Intervention

During the universally offered screening intervention, STI screening will be offered to all eligible adolescents, regardless of risk. All eligible patients will also complete the SHS, will be informed of the CDC GC/CT testing recommendations and then be given the option to decline STI testing using the tablet device. During this phase, the SHS results will not be available to the clinician. STI testing recommendations will be based only on the patient's decision to undergo GC/CT testing. Like the process followed in the targeted screening phase, if the clinician follows the CDS that informs the clinician that the patient agreed to GC/CT screening and consequently orders testing, urine GC/CT testing will be performed.

Group II: Targeted STI ScreeningActive Control1 Intervention

Data from the Sexual Health Screen (SHS) will be integrated into the Electronic Health Record (EHR) and will provide Clinical Decision Support (CDS) for GC/CT testing based on SHS-calculated STI risk. Patients will be classified as at high risk for STIs, at risk or low risk if they deny any history of sexual activity. When patients classify as at high risk, clinicians will receive CDS that STI testing is "highly recommended"; when they care for patients who classify as at risk, they will receive CDS that STI testing is "recommended"; when caring for patients who classify as at low risk, they will receive CDS that STI testing "is not necessary at this time." If the clinician chooses to follow the recommendation for screening based on patient's risk assessment, and the patient consents to testing on the tablet device, urine GC/CT testing will be performed.

Group III: BaselineActive Control1 Intervention

Current STI screening rates.