Health Information Technology for Sexually Transmitted Infections

Recruiting at 1 trial location

Overseen By Meleah Boyle

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

Disqualifiers: Critically ill, Cognitively impaired, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

37500 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 5 6 7 8}

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?

Group I: SHS-derived CDS Experimental Treatment 1 Intervention

All adolescents seen in the emergency department that meet eligibility criteria will be offered the sexual health survey (SHS) during the pragmatic trial.

Group II: Usual care Active Control 1 Intervention

All adolescents seen in the emergency department that meet eligibility criteria prior to implementation of SHS-derived CDS.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Improvement of Clinical Decision Support via an Embedded Survey Tool. Rubins, D., Dutta, S., Wright, A., et al.[2019]

The implementation of a computerized clinical decision support tool for gonorrhea and chlamydia screening in emergency departments achieved a patient capture rate of about 64.5-64.6%, indicating good integration into clinical workflows.

Despite the high capture rates, only 9.9% and 4.4% of patients agreed to testing, suggesting that while the tool is effective in identifying patients, further efforts are needed to encourage adolescents to consent to screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Information Technology-Assisted Screening for Gonorrhea and Chlamydia in a Pediatric Emergency Department. Reed, JL., Dexheimer, JW., Kachelmeyer, AM., et al.[2021]

A review of 58 randomized controlled trials found that computer-based clinical decision support systems (CDSSs) are highly diverse, with 74 different systems varying in their design, context of use, and the type of decision support they provide.

Most CDSSs (84%) required additional staffing to manage their input or output, highlighting the potential resource implications and the need for careful consideration when applying findings from CDSS studies to different clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A taxonomic description of computer-based clinical decision support systems. Berlin, A., Sorani, M., Sim, I.[2019]

The implementation of a Clinical Decision Support (CDS) system in the San Juan de Alicante Clinical Laboratory demonstrated improved workflows and integration of care, showcasing its potential to enhance laboratory test utilization and clinical decision-making.

By using AlinIQ CDS and AlinIQ AIP software, the laboratory was able to monitor and track the impact of interventions, indicating that CDS systems can serve as valuable tools for optimizing healthcare delivery and adding clinical value for physicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Decision Support systems: A step forward in establishing the clinical laboratory as a decision maker hubA CDS system protocol implementation in the clinical laboratory. Flores, E., Salinas, JM., Blasco, Á., et al.[2023]

Clinical decision support systems (CDSSs) significantly increase HIV testing rates in both hospital and non-hospital settings, with a pooled risk ratio of 2.57 in hospitals and 2.13 in non-hospital settings based on a systematic review of 22 studies.

While CDSSs enhance testing, the impact on actual HIV diagnosis remains mixed, indicating a need for further research to fully understand their effectiveness in achieving universal HIV testing and treatment goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical decision support systems to guide healthcare providers on HIV testing. Smit, M., Jordans, CCE., Reinhard, JM., et al.[2022]

The advanced clinical decision support system (CDSS) HIGEA effectively generated alerts for potential adverse drug events (ADEs), with 51% of alerts leading to interventions that prevented possible medication errors during a 6-month observational study.

The most effective intervention program was for dose adjustments in renal impairment, achieving a positive predictive value (PPV) of 0.51, indicating that the system significantly improved medication safety across various clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Evaluation of a Clinical Decision Support System to Improve Medication Safety. Ibáñez-Garcia, S., Rodriguez-Gonzalez, C., Escudero-Vilaplana, V., et al.[2020]

A study involving 76 panelists reached consensus on 110 out of 122 important items related to the design and use of electronic health records (EHRs) with clinical decision support systems (CDSSs), highlighting key areas such as patient demographics, medication prescribing, and alert quality.

The findings suggest that considering these consensus items could enhance the safe and effective use of EHRs in healthcare, although further research is needed to confirm their impact on patient safety and outcomes in Palestinian hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Merits, features, and desiderata to be considered when developing electronic health records with embedded clinical decision support systems in Palestinian hospitals: a consensus study. Shawahna, R.[2023]

A randomized controlled trial is being conducted to evaluate the effectiveness of computerized decision support systems (CDSSs) in improving clinical practice and quality of care for patients in a large general hospital's internal medicine department.

The primary outcome of the study is the resolution rate of medical problems identified by CDSS-generated reminders, with secondary outcomes including specific reminders for venous thromboembolism prevention and overall patient mortality, which will help assess the impact of CDSSs on patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing an evidence-based computerized decision support system to improve patient care in a general hospital: the CODES study protocol for a randomized controlled trial. Moja, L., Polo Friz, H., Capobussi, M., et al.[2019]

A new clinical decision support system for sexual health care in emergency departments was developed, which was rated as useful by clinicians (mean score 3.4 out of 4) and easy to use by adolescents (95% found it easy to complete).

The system effectively provided tailored, evidence-based recommendations and improved understanding of emergency contraception options among adolescents, indicating its potential to enhance sexual health services in emergency settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Novel Computerized Clinical Decision Support System to Improve Adolescent Sexual Health Care Provision. Miller, MK., Mollen, C., Behr, K., et al.[2023]

Health Information Technology (HIT), particularly computer-based Clinical Decision Support (CDS) systems, can significantly enhance the quality of care by improving adherence to guidelines, enhancing surveillance, and reducing medication errors.

Despite the potential benefits of HIT and CDS systems in integrating patient data to aid clinical decision-making, the lack of standardized practices remains a major barrier to their widespread implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standards in health information technology: promise and challenges. Jenders, RA.[2016]

The review highlights that Clinical Decision Support Systems (CDSS) are popular but face challenges in evaluation and adoption, indicating a need for better understanding of their effectiveness in real clinical settings.

It suggests that new evaluation frameworks that consider technological, human, and organizational factors could enhance the assessment of CDSS, particularly in improving diagnostic functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health information systems evaluation: a focus on clinical decision supports system. Yusof, MM., Paul, RJ., Stergioulas, L.[2018]

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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 ...