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临床试验/NCT03833284
NCT03833284已完成不适用

Implementation of a Transvaginal Ultrasound Surveillance Program in Women With a History of Previous Preterm Birth: Disseminating Evidenced Based Practices for Reducing Preterm Birth in Appalachian Kentucky

Niraj Chavan1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2019年6月3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
发起方
入组人数
56
试验地点
1
主要终点
Change in attitudes towards TVU screening among patients and practitioners

研究概览

简要总结

Preterm Birth is the number one cause of infant morbidity and mortality worldwide and represents an important health disparity in the United States, particularly across the state of Kentucky. The best biomarker for the prediction of preterm birth is transvaginal ultrasound (TVU). This study will attempt to identify and rectify provider and patient related barriers to TVU screening implementation.

详细描述

Preterm birth is the number one cause of infant morbidity and mortality worldwide and represents an important health disparity in the United States, and especially across the state of Kentucky. The best biomarker for the prediction of preterm birth is transvaginal ultrasound (TVU) measurement of cervical length. However, several unique provider and patient related barriers for implementation of this screening limit the widespread uptake of this evidence based practice in Appalachian KY. The investigators propose to adopt a dissemination and implementation science approach using the Consolidated Framework for Implementation Research (CFIR) as the guiding framework for identification of key areas of knowledge deficits as well as attitudes, practices and perceived barriers among prenatal care providers and patients in eastern KY towards TVU cervical length screening using a mixed - methods design. This will be utilized to develop a multifaceted implementation strategy best suited for addressing and overcoming barriers identified by the target population in eastern KY. The investigators anticipate that such an implementation strategy will likely include an educational component targeting obstetric care providers and patients in addition to hands-on TVU cervical length evaluation as well as telemedicine support and surveillance. Three community based sites (Hazard, Morehead and Ashland, KY) will be recruited for implementation of this multi-component pilot program focused on community engagement and outreach targeting obstetric providers and their patients. At the end of the pilot implementation phase, acceptability of the study intervention and feasibility of implementation will be evaluated along with a preliminary assessment of effectiveness of implementation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Participant
  • •Female Sex
  • •Prior history of preterm birth (for initial set of interviews), no preterm birth history required for intervention feedback
  • •Current pregnant status

排除标准

  • •Participant
  • •Inclusion Criteria: Provider
  • •Certified as obstetric/gynecologic provider

研究组 & 干预措施

Participant Barriers to TVU Screening

Experimental

Patients with a history of pre-term birth will be identified through a review of their medical history. Patients will then be asked to complete a survey assessing their knowledge of transvaginal ultrasound screening. Patients will then be asked to attend in-person or online workshops designed to increase patient knowledge of TVU screening guidelines and benefits. Finally, patients will complete exit surveys to determine whether their attitudes and beliefs towards screening have changed over time.

干预措施: Participant Barriers to TVU Screening (Behavioral)

Provider Barriers to TVU Screening

Experimental

Obstetric and Gynecologic Providers will be identified based on prior working relationships with the University of Kentucky outreach programs. Chosen providers will be asked to complete a survey assessing their attitudes towards TVU screening. Following completion, providers will be asked to attend either in-person or online workshops designed to increase provider knowledge of TVU screening guidelines and benefits. Finally, providers will complete exit surveys to determine whether their attitudes and beliefs toward screening have changed over time.

干预措施: Provider Barriers to TVU Screening (Behavioral)

结局指标

主要结局

Change in attitudes towards TVU screening among patients and practitioners

时间窗: At baseline and at one year.

The primary purpose of this study is to evaluate the change in attitudes towards TVU screening among patients and practitioners. This will be accomplished by conducting a qualitative interview with each participant at baseline and again at one year (after completing the CLEAR program workshop).

Potential for future TVU screening implementation based on changes in attitudes towards TVU screening among providers and participants.

时间窗: At baseline and at one year.

The primary purpose of this study is to evaluate the change in attitudes towards TVU screening among patients and practitioners. This will be accomplished by conducting a qualitative interview with each participant at baseline and again at one year (after completing the CLEAR program workshop). Analysis of these interviews will aid in determining feasibility of implementing a future TVU screening component in Obstetric and Gynecologic care.

次要结局

  • Rate of inpatient hospitalization for preterm labor management prior to delivery(Through study completion, average of 1 year from study initiation.)
  • Rate of preterm birth at <34 weeks gestation(Through study completion, average of 1 year from study initiation)
  • Rate of preterm birth at <37 weeks gestation(Through study completion, average of 1 year from study initiation)
  • Number of TVU scans identifying a short cervix (≤ 25 mm) in any pregnant women at each study site(Through study completion, average of 1 year from study initiation.)
  • Rates of clinical therapy(Through study completion, average of 1 year from study initiation.)

研究者

发起方
Niraj Chavan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Niraj Chavan

Assistant Professor in Maternal Fetal Medicine

University of Kentucky

研究点 (1)

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