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临床试验/NCT04974736
NCT04974736已完成不适用

Electronic Pediatric Office Systems to Support Treatment for Parental Tobacco Use

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 817 人开始时间: 2021年7月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
817
试验地点
2
主要终点
Parental Combusted Tobacco Quit Rate at 12 Months

研究概览

简要总结

The proposed project aims to develop an innovative and disseminable electronic health record (iEHR)-based approach that supports optimal primary care workflows to routinely screen families for tobacco and e-cigarette use, address household smoking behavior and promote smoke-free and e-cigarette free home and car rules in a routine and effective manner in the pediatric setting. Additionally, parents enrolled in the study will be offered assistance by a community health navigator (CHN). This study aims to examine how effective the iEHR + Navigator strategy is compared to usual care control.

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
Single (Outcomes Assessor)

盲法说明

After the intervention has been assigned at random to one practice in each of the six pairs, the intervention will be blinded at random with either the label "A" or the label "B", and the other label will be assigned to the control practice. The statisticians will be blinded as to which of "A" and "B" is the intervention until the analyses are completed.

入排标准

性别
All
接受健康志愿者

入选标准

  • Parents or legal guardians who smoke, are present at the visit, and whose child is seen by a child healthcare clinician in a participating practice. "Smoker" will be defined as answering "yes" to either of the screening questions: "Have you smoked a cigarette, even a puff, in the past 7 days?" and "Have you smoked any other tobacco product (cigars like black and mild, hookah), even a puff, in the past 7 days?"

排除标准

  • Parent/legal guardian does not speak English;
  • No telephone; and
  • Prior enrollment in the study during a previous visit.

结局指标

主要结局

Parental Combusted Tobacco Quit Rate at 12 Months

时间窗: 12-months

Parental 7-day combusted tobacco quit rates, as assessed by validated surveys, biochemically confirmed at 12 months between the intervention \& usual care arms

次要结局

  • Rates of Parental Quit Attempts(12-months)
  • Rates of Parental Use of Pharmacotherapy or Services(12-months)
  • Rates of Parental Institution of Smoking and Vaping Bans in Their Homes and Cars(12-months)
  • Incremental Cost Per Quit of the Intervention(12-months)
  • Rates of Tobacco Use Treatment Delivery(36 months)

研究者

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

Jonathan P. Winickoff, MD, MPH

Professor

Massachusetts General Hospital

研究点 (2)

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