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临床试验/NCT06014177
NCT06014177已完成不适用

A Digital Patient Decision Aid to Increase Sexually Transmitted Infection Testing in the Emergency Department: The STIckER Study

Columbia University2 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2023年9月12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
184
试验地点
2
主要终点
ED STI Testing Rate

研究概览

简要总结

This study is a pilot randomized trial of STIckER in which 40 providers (20 trained in using the STIckER decision aid and 20 providing standard care) will enroll a total of 140 sexually active young Emergency Department (ED) patients over six months in a pediatric and adult ED setting. The primary goal is to determine if sexually active young individuals who use STIckER are more likely to undergo STI testing. By developing an effective automated digital tool to increase STI testing, the investigators aim to improve evidence-based sexual health education, reduce STI rates, and enhance the health outcomes of young individuals nationwide.

详细描述

Improving sexually transmitted infection (STI) screening is vital to combat the STI epidemic, especially among adolescents and young adults (AYA) aged 15-24 years in the United States. Inadequate testing for STIs in different body areas contributes to disease transmission. Emergency Departments (EDs) treat a significant number of young individuals, many of whom come from economically disadvantaged backgrounds and minority communities. Previous research has shown inconsistent use of contraception in this population, and despite the willingness of ED providers to support sexual health interventions, time and resource limitations present implementation challenges. To address this issue, the investigators propose developing STIckER (STI ChecK in the ER), a digital patient decision aid for STI testing in the ED that promotes shared decision-making. STIckER involves three steps: (1) patients complete a nonjudgmental sexual health screening assessment by scanning a quick-response (QR) code, (2) educational modules facilitate shared decision-making (SDM) by connecting personalized STI risk with evidence-based testing recommendations, and (3) a confidential, color-coded digital infographic aids the patient-provider discussion on STI testing.

研究设计

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

入排标准

年龄范围
14 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •AYA aged 14-24 years
  • •Sexually active within the past 6 months (per self-report)
  • •Ability to speak English

排除标准

  • •Severe illness
  • •Cognitive impairment
  • •Inability to speak English

研究组 & 干预措施

Control

Other

After enrollment but before the start of their clinical visit, participants assigned to a provider in the control arm will scan a QR code. They will receive a prompt stating, "If you would like to be tested for a sexually transmitted infection today, please tell your medical doctor."

At the end of the visit, the participant will complete the "Patient Control Exit Survey" while the provider will complete the "Provider Control Exit Survey".

These participants will not receive STIckER training.

干预措施: Control (Other)

STIckER

Experimental

After enrollment but before the start of their clinical visit, participants assigned to a provider in the intervention arm will scan a QR code using their personal mobile phone at the start of their ED visit. If they do not have a mobile phone present, a secure password-protected tablet will be provided by the research staff. This will lead them to go through the STIckER decision aid modules. After completing the modules, participants will show the final outcome to their ED provider which may facilitate an SDM conversation about STI testing.

At the end of the visit, the participant will complete the "Patient Intervention Exit Survey" while the provider will complete the "Provider Intervention Exit Survey.

干预措施: STIckER (Behavioral)

结局指标

主要结局

ED STI Testing Rate

时间窗: Day 0

Percent of individuals with any gonorrhea or chlamydia testing performed in the ED on the day of their STIckER visit.

次要结局

  • Genitourinary STI testing Rate(Day 0)
  • Intervention Appropriateness Measure (IAM) Score(At completion of all patient visits (within 6 months of enrollment))
  • STI Positivity Rate(Day 0)
  • Acceptability of Intervention Measure (AIM) Score(At completion of all patient visits (within 6 months of enrollment))
  • Extragenital STI testing Rate(Day 0)
  • Feasibility of Intervention Measure (FIM) Score(At completion of all patient visits (within 6 months of enrollment))

研究者

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

Jason E. Zucker

Assistant Professor of Medicine

Columbia University

研究点 (2)

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