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临床试验/NCT03442530
NCT03442530已完成不适用

Tobacco Use in Pregnancy Intervention for Cessation

Kristin Ashford2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2018年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
2
主要终点
Smoking cessation

研究概览

简要总结

The proposed project will test the effectiveness of the novel delivery of an established tobacco cessation treatment among pregnant women in Kentucky. Tobacco use during pregnancy is one of the most modifiable risk factors associated with poor birth and maternal outcomes and yet smoking prevalence among pregnant women in Kentucky is among the highest in the county and estimated to be twice that of the national average, with no meaningful declines observed in twenty years.

详细描述

The purpose of this pilot project is to test effectiveness of a tobacco-treatment cessation intervention (American College of Obstetricians and Gynecologists (ACOG) 5 A's) through use of a non-physician healthcare champion from within the clinic's existing infrastructure. This Tobacco use in Pregnancy Intervention for Cessation (ToPIC) will involve training the identified healthcare provider to become a Certified Tobacco Treatment Specialist (CTTS) and to administer the 5 A's to pregnant Medicaid patients receiving prenatal care through two high-volume Kentucky obstetrics clinics. This trial will provide evidence to evaluate this approach to delivering an established intervention in clinical practice.

The Investigators propose to test the effectiveness of the clinical intervention by using a two-armed cluster randomized controlled design. Eligible participants will be randomized to the intervention (ToPIC) or standard of care for smoking cessation in pregnancy. This pilot project will gather quantitative and qualitative data for a mixed-method, multi-stakeholder process evaluation of intervention training and delivery. Furthermore, the Investigators' use of Medicaid claims data to examine healthcare utilization outside of maternal and infant well-care visits will enhance understanding of the strengths and limitations of these data for future evaluations. This study has the potential to significantly impact the most vulnerable in Kentucky, where rates of tobacco use among pregnant women are among the highest in the nation.

研究设计

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

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • tobacco user
  • able to read and write English
  • Medicaid eligible

排除标准

  • 未提供

结局指标

主要结局

Smoking cessation

时间窗: Baseline to third trimester

Change in urine cotinine level

次要结局

  • Smoking cessation after delivery(Prior to delivery hospitalization discharge, estimated 3 days)
  • Infant birth weight(At time of delivery)
  • Health care utilization outside of well-visits(Birth to 6 months)
  • Number of cigarettes per day(Baseline to third trimester)
  • Gestational age(At time of delivery)

研究者

发起方
Kristin Ashford
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kristin Ashford

Associate Dean of Undergraduate Faculty Affairs, University of Kentucky College of Nursing

University of Kentucky

研究点 (2)

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