37500 Participants Needed

Health Information Technology for Sexually Transmitted Infections

Recruiting at 1 trial location
MB
ML
MG
MB
Overseen ByMeleah Boyle
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Children's National Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special electronic tool, SHS-derived CDS (Sexual Health Survey-derived Electronic Clinical Decision Support), can detect sexually transmitted infections (STIs) more effectively than usual care in emergency departments. The tool uses answers from a sexual health survey to help doctors identify who might need further testing or treatment. The study aims to determine if this method finds more STIs, particularly in individuals at higher risk due to their sexual activity or background. It seeks adolescents aged 15-21 who visit the emergency department and can complete the survey. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance STI detection and care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this electronic clinical decision support is safe for STI detection?

Research has shown that using a sexual health survey (SHS) to develop electronic tools for doctors can increase STI testing rates, particularly among high-risk teens. This tool aids doctors in deciding when to test for STIs by providing additional information from patient surveys.

No safety concerns have been reported with the SHS-based tool itself. Since this method focuses on improving testing decisions, it does not involve new medications or medical procedures. Instead, it employs technology to enhance healthcare decision-making.

In simple terms, the SHS-based tool promotes smarter decision-making rather than introducing a new treatment. The primary goal is to ensure prompt detection and treatment of STIs without introducing new health risks.12345

Why are researchers excited about this trial?

Researchers are excited about the Health Information Technology for Sexually Transmitted Infections trial because it explores a new approach called SHS-derived CDS, which uses a sexual health survey to guide care for adolescents in emergency departments. Unlike traditional methods that rely heavily on standard patient interviews and history-taking, this approach integrates clinical decision support (CDS) derived from survey responses, potentially streamlining the identification and management of sexually transmitted infections. This method aims to enhance the accuracy and efficiency of diagnosis and treatment, making it a promising tool for improving adolescent sexual health outcomes.

What evidence suggests that SHS-derived CDS is effective for STI detection?

Research has shown that electronic tools assisting doctors in decision-making can increase the detection of sexually transmitted infections (STIs). In this trial, participants will receive either the SHS-derived CDS, an electronic clinical decision support tool, or usual care. One study found that a private electronic survey assessing STI risk in teenagers identified more cases. By integrating patient information into electronic health records, these tools can provide specific advice, enhancing the effectiveness of STI screening. Early results suggest that electronic decision support may lead to higher STI detection rates than usual methods, particularly in high-risk groups. This approach aims to improve STI detection by using technology to guide healthcare decisions more effectively.25678

Are You a Good Fit for This Trial?

This trial is for adolescents aged 15-21 years who are seeking care in the emergency department. It's designed to see if a special health survey can help find sexually transmitted infections (STIs) better than the usual way doctors check for these infections.

Inclusion Criteria

I am between 15 and 21 years old and seeking care in the emergency department.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants receive either SHS-derived electronic CDS or usual care

Ongoing during ED visits
Visits occur during emergency department encounters

Follow-up

Participants are monitored for STI detection rates 3-7 days after ED visit

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • SHS-derived CDS
Trial Overview The study is testing whether an electronic clinical decision support system, derived from a sexual health survey, improves STI detection rates compared to standard practices without this technology. The comparison will be made over time and also look at different levels of sexual risk and race/ethnicity.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: SHS-derived CDSExperimental Treatment1 Intervention
Group II: Usual careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials
227
Recruited
258,000+

Published Research Related to This Trial

A review of 77 articles on clinical decision support systems (CDSSs) revealed that only 22% used numerical data, while 51% utilized coded data, primarily relying on international terminologies like ICD and LOINC.
Over half of the authors reported barriers to CDSS implementation, mainly due to the lack of standardized electronic data, highlighting that data standardization is essential for the effective development and integration of CDSSs.
The role of standardized data and terminological systems in computerized clinical decision support systems: literature review and survey.Ahmadian, L., van Engen-Verheul, M., Bakhshi-Raiez, F., et al.[2022]
Clinical decision support (CDS) tools significantly improve the prescription of appropriate medications and dosages, with a pooled risk ratio of 1.48 based on 6 studies, indicating they are effective at the point of medication ordering or dispensing.
CDS tools also enhance laboratory monitoring and treatment responses to abnormal test results, showing a pooled risk ratio of 1.40, but evidence for their effectiveness in reducing adverse drug events remains inconsistent, suggesting further research is needed.
The Effect of Laboratory Test-Based Clinical Decision Support Tools on Medication Errors and Adverse Drug Events: A Laboratory Medicine Best Practices Systematic Review.Whitehead, NS., Williams, L., Meleth, S., et al.[2022]
An electronic survey tool integrated within the electronic health record was developed to gather feedback from end users on clinical decision support systems (CDSS), enhancing their design and functionality.
This approach allows for direct user input, which is crucial for monitoring and improving CDSS performance, ultimately aiming to enhance patient care and workflow efficiency.
Continuous Improvement of Clinical Decision Support via an Embedded Survey Tool.Rubins, D., Dutta, S., Wright, A., et al.[2019]

Citations

RePORT RePORTER - National Institutes of Health (NIH) |In the second aim, we will conduct a pragmatic trial using an interrupted time series design to measure the impact of SHS-derived electronic CDS on STI ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39572251/
Multisite Implementation of a Sexual Health Survey and ...Objectives: The objectives of this study were to implement a patient-facing, confidential electronic survey to assess adolescent risk for STIs ...
Health Information Technology for Sexually Transmitted InfectionsWe will compare differences in sexually transmitted infection (STI) detection rates between sexual health survey (SHS)-derived electronic clinical decision ...
Adolescent Sexually Transmitted Infection Screening in th...Electronic integration of patient-reported data with CDS offers one such solution. The objective of this study is to compare targeted and universally offered ...
Record History | ver. 3: 2019-06-17 | NCT03715335Data 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 ...
A Computerized Sexual Health Survey Improves ...Conclusions. Providing SHS-derived decision support to ED clinicians led to increased STI testing rates in adolescents at high risk for infection, particularly ...
Health Information Technology to Reduce Disparities in Ad...We hypothesize that population-based STI detection rates will be higher when SHS-derived electronic CDS is provided compared to usual care.
Multisite Implementation of a Sexual Health Survey and ...Objectives: The objectives of this study were to implement a patient-facing, confidential electronic survey to assess adolescent risk for STIs ...
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