跳至主要内容
临床试验/NCT03715335
NCT03715335已完成不适用

Improving the Detection of STIs in the Pediatric Emergency Department: A Pragmatic Trial

Children's Hospital Medical Center, Cincinnati10 个研究点 分布在 1 个国家目标入组 98,413 人开始时间: 2020年7月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
98,413
试验地点
10
主要终点
GC/CT Detection Rates

研究概览

简要总结

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.

详细描述

Adolescents are disproportionately affected by sexually transmitted infections (STIs). The STI epidemic among youth is a national public health priority and enhanced STI diagnosis, treatment, and reduction in adolescents is needed.

Adolescents frequently access the emergency department (ED) for care. Although the Centers for Disease Control and Prevention (CDC) recommend universal HIV screening in EDs, no recommendations currently exist for gonorrhea and chlamydia (GC/CT) screening. Addressing the effectiveness and integration of ED-based STI screening is critically needed.

Insufficient knowledge of the ideal structure for delivery is a barrier to the implementation of ED-based GC/CT screening. While universally offered screening (offered to all, regardless of risk) may detect a larger number of cases than targeted screening (screening only those disclosing high risk sexual behavior), it is more resource-intensive and may result in more false positive cases. The investigators each studied targeted (Goyal) and universally offered (Reed) ED-based GC/CT screening via electronically entered patient-reported data providing real-time clinical decision support (CDS). They have shown that both strategies are acceptable, feasible, and result in increased STI screening rates; but it is unknown which method is most efficient and cost effective when instituted across a national sample of pediatric EDs.

The scientific premise of this application is to leverage 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 when implemented in a real-world clinical setting. To be sustainable, the ideal screening strategy must be easily incorporated into the clinical workflow. Electronic integration of patient-reported data with CDS offers one such solution. The objective of this study is to compare targeted and universally offered STI screening approaches by seamlessly integrating real-time CDS based on electronically obtained patient-reported data into the normal ED workflow. The investigators will execute a multicenter comparative effectiveness pragmatic trial within a national sample of pediatric EDs through the Pediatric Emergency Care Applied Research Network (PECARN).

Specific Aim 1: To compare the effectiveness of usual care, targeted screening and universally offered screening in EDs through a pragmatic trial that applies a human factors systems approach to implement GC/CT screening into routine clinical care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Screening
盲法
None

入排标准

年龄范围
15 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •15-21 years of age

排除标准

  • •unable to understand English
  • •critically ill
  • •cognitive impairment or altered mental status
  • •unable to provide consent for completion of the sexual health screen and STI screening.

研究组 & 干预措施

Baseline

No Intervention

Current STI screening rates.

Targeted STI Screening

Active Comparator

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.

干预措施: Targeted STI Screening (Other)

Universally Offered STI Screening

Active Comparator

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.

干预措施: Universally Offered STI Screening (Other)

结局指标

主要结局

GC/CT Detection Rates

时间窗: Through study completion, an average of 2 years

Our primary outcome measure is GC/CT detection rates per 1000 eligible patients.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Reed

Professor of Clinical Pediatrics, Attending Physician Division of Emergency Medicine

Children's Hospital Medical Center, Cincinnati

研究点 (10)

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