Use of a Rapid Turnaround Test for Gonorrhea & Chlamydia to Improve Treatment of Women Presenting With Possible Sexually Transmitted Infections
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Number of Participants Treated With Antibiotics
研究概览
简要总结
The purpose of this study is to evaluate the effect of utilizing a rapid turnaround CT/NG test on treatment of female patients in the emergency department or urgent care setting with possible STIs.
详细描述
All females ages 18-55 presenting to the University of Maryland Medical Center Emergency Department or Urgent Care whose provider suspects sexually transmitted infection will be offered study enrollment and be randomly assigned to either the control or the experimental group. Both groups will have a urinalysis, a pregnancy test, a pelvic exam, and an endocervical sample collected, but the experimental group's urine will be used to run the rapid turnaround test (RTAT) instead of the standard PCR. Data will be collected regarding provider decision making, length of stay in the emergency department, patient satisfaction, clinician satisfaction, further healthcare sought by patient, and cost surrounding each treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants, investigators, and care providers will be masked to the experimental or control arm prior to enrollment in the study. Once the participant has been enrolled in the study, they will be randomized to either the control arm or the experimental arm. Once randomization has occurred, participants, care providers, and the investigators will know which group the participants are in.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients age 18-55
- •Signs or symptoms consistent with sexually transmitted infection
- •Medical provider willing to consider the result of the rapid turnaround test in decision to treat for gonorrhea/chlamydia
- •Must have a urine specimen obtained and a pelvic exam performed as part of the anticipated standard of care evaluation
- •Provides informed consent
排除标准
- •Signs of systemic infection
- •Patient in whom the provider is unwilling to consider the result of the rapid turnaround test
- •Patient who reports being treated for either gonorrhea or chlamydia in the preceding 3 months
- •Patients undergoing evaluation for sexual assault
- •Patients that are known to be pregnant or express concern that they may be pregnant
- •Incarcerated patients
- •Students/Employees of the facility
- •Presence of any other condition(s) that the investigator feels makes the patient unsuitable for study inclusion.
结局指标
主要结局
Number of Participants Treated With Antibiotics
时间窗: 7 days
Evaluate the effect of a rapid turnaround CT/NG test compared to standard of care on antibiotic prescription for female patients with STI.
次要结局
- Average Score for Patient Satisfaction With Overall Experience.(7 days)
- Average Score for Patient Satisfaction With Treatment Effectiveness.(7 days)
- Length of Stay (Minutes)(7 days)
- Healthcare Costs.(7 days)
- Average Score for Patient Satisfaction With Provider Explanation.(7 days)
- Average Score for Patient Satisfaction With Wait Times During Visit.(7 days)
- Percentage of Patients With Rapid Turnaround CT/NG (RPAT) Tests That Are CONSISTENT With Usual Care Test (PCR) in Subjects That Had Both Performed.(7 days)
- Number of Patients That Required Follow-up Care Within 7 Days(7 days)
研究者
Richard Gentry Wilkerson
Assistant Professor
University of Maryland, Baltimore