跳至主要内容
临床试验/NCT01882348
NCT01882348已完成不适用

Changing Pediatric Office Systems Nationally to Address Parental Tobacco Use

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 3,888 人开始时间: 2015年4月14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
3,888
试验地点
2
主要终点
Delivery of Assistance

研究概览

简要总结

The proposed study is a Cluster Randomized Controlled Trial designed to test the sustainability of a previously developed, tested, effectively implemented tobacco control strategy-the CEASE intervention, employing state of the art tobacco dependence treatment for parents who smoke.

详细描述

The CEASE intervention works within existing systems of care to address parental smoking. Based on national guidelines and extensive qualitative research obtained in pilot testing, elements of CEASE can be tailored to work with particular practices' staffing, resources, and physical configuration. CEASE integrates evidence-based tobacco-use screening, cessation assistance, and referral to outside services into visits with families in pediatric clinics. Elements include (1) Identification of smokers and self-assessment of quitting preferences; (2) Counseling (brief motivational messaging elements include collaborative goal setting, set quit date, personal barriers to quitting, problem-solving strategies, implementing smoke-free homes and cars, and social support, strategies shown to increase satisfaction with the pediatric visit.(3) Medication (NRT prescription and free 1 week supply (while supplies last)-including for those cutting down to quit as recommended in latest guidelines); (4) Quitline enrollment via faxed enrollment form; and (5) Review of CEASE action sheets at each visit until the family is smoke-free. We train practices in the adoption, implementation, and maintenance of the intervention. A more detailed training manual discusses additional in-depth strategies for maximizing billing and reimbursement, materials for seasonal cessation opportunities and supporting employees' own cessation efforts.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parents or guardians who smoke or who are former smokers (quit in the last 2 years), are present at the visit, and whose child (any age) is seen by a pediatrician in a participating practice.
  • "Smoker" will be defined as answering "yes" to the screening question: "Have you smoked a single cigarette, even a puff, in the past 7 days?"
  • "Former smoker" will be defined as answering "no" to the screening question: "Have you smoked a single cigarette, even a puff, in the past 7 days?" and "yes" to the screening question: "Have you quit smoking in the last 2 years?"

排除标准

  • Parents under age 18
  • Parents who have a child with a medical emergency (any condition requiring transfer for immediate medical intervention)
  • Non-consenting individuals
  • Non-English speakers
  • Prior enrollment in the study during a previous healthcare visit.

研究组 & 干预措施

Usual Care Control

No Intervention

Control groups will receive equal number of contacts for training in preparation for enrollment and data collection for the study.

Clinicians will be given the option to receive a standard American Academy of Pediatrics tobacco control pamphlet to distribute.

Control groups have the option to receive access to the CEASE online module intervention at the conclusion of the research study which allows practitioners in this group to receive 26 continuing education credit hours.

Intervention

Experimental

The Intervention Group will receive the CEASE Intervention

干预措施: CEASE Intervention (Behavioral)

结局指标

主要结局

Delivery of Assistance

时间窗: over 2 years

• Delivery of cessation assistance, defined as prescribing medication, or enrolling in the quitline or other program

次要结局

  • Parental quit rate(over 2 years)
  • Change in practice prevalence of parents who smoke(over 2 years)
  • Smokefree homes and cars(over 2 years)
  • Parental use of pharmacotherapy or services(over 2 years)

研究者

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

Jonathan P. Winickoff, MD, MPH

Jonathan P. Winickoff, MD

Massachusetts General Hospital

研究点 (2)

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