Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes

描述(由申请人提供)：儿童慢性二手烟暴露(SHSE)损害肺功能，并导致呼吸系统疾病、喘息、咳嗽、哮喘、中耳疾病和婴儿猝死综合征。住进新生儿重症监护病房(NICU)的早产、低出生体重儿特别容易受到SHSE的影响，许多婴儿在出院前表现出严重的呼吸系统或慢性肺部疾病。由于吸烟仍然集中在受教育程度较低和贫困的社区，有家庭吸烟者的NICU家庭面临与烟草有关的健康差距的巨大风险--这对资源有限的家庭及其居住的社区来说是一个巨大的负担。这项调查的主要目的是评估医院发起的行为干预措施与传统护理做法相比，在具有特别高社会和医疗风险的NICU婴儿的低收入、多民族父母中减少家庭SHSE的效果。将使用随机、对照、平行分组设计来测试在医院启动并在家中使用动机访谈加动机激励(MI+)完成的SHSE计划是否比针对NICU父母的传统护理(CC)更有效。MI+与CC对家庭吸烟和婴儿吸烟暴露的影响预计将通过改变的动机和治疗参与来调节。NICU中报告有家庭吸烟者的396个家庭中有高呼吸风险的婴儿将被随机抽样。MI+干预将包括4次一小时的咨询会议(2次在医院，2次在出院后在家中)，以及对出席会议和建立家庭禁烟令的激励。CC将包括书面材料，包括吸烟的影响信息和在与家庭生活协调员的会议上讨论的戒烟技巧。咨询和面试将用西班牙语和英语进行。主要疗效变量将包括SHSE的客观和有效措施(婴儿可替宁、家用尼古丁空气监测仪、SHSE的时间线回传)。结果将在干预后1个月和6个月使用广义线性混合模型、泊松和Logistic回归进行评估。这将是第一次在NICU的背景下对针对SHSE的激励策略的创新组合进行研究，以改善脆弱婴儿及其家庭的健康，潜在地节省数百万医疗保健资金。这项试验还可能展示一种向年轻、少数族裔和经济上处于不利地位的家庭提供预防性服务的实用方法，这些家庭不太可能向传统诊所提供这种护理。经验丰富的行为和临床研究人员、提示干预可行性和前景的试验数据、庞大且可接触的人口以及非凡的基础设施确保了研究的成功。 公共卫生相关性：长期暴露在二手烟(SHS)中的儿童肺功能减弱，更有可能患有呼吸道感染、哮喘、中耳疾病、发育不良、神经认知缺陷和婴儿猝死综合征。新生儿重症监护病房(NICU)收治的低出生体重儿和高呼吸风险婴儿特别容易受到SHS的影响，特别是考虑到许多NICU家庭存在贫困，他们报告有家庭吸烟者。在NICU环境中启动的消除二手烟暴露(SHSE)的有效干预措施可能会降低婴儿发病率、死亡率和相关成本，并可能减少与烟草相关的健康差距。

DESCRIPTION (provided by applicant): Chronic secondhand smoke exposure (SHSe) in children compromises pulmonary function and contributes to respiratory illness, wheeze, cough, asthma, middle ear disease, and sudden infant death syndrome. Preterm, low birth weight infants admitted to a Neonatal Intensive Care Unit (NICU) are especially vulnerable to the effects of SHSe, with many exhibiting significant respiratory or chronic lung conditions prior to discharge. Because smoking remains concentrated in less educated and impoverished communities, NICU families with household smokers are at significant risk for tobacco-related health disparities--a substantial burden to families with limited resources and the communities in which they reside. The primary aim of this investigation is to evaluate the efficacy of a hospital initiated, behavioral intervention to reduce household SHSe, compared to conventional care practices, in low-income, multi-ethnic parents of NICU infants at particularly high social and medical risk for adverse effects of SHSe. A randomized, controlled, parallel group design will be used to test whether a SHSe program initiated in the hospital and completed in the home using motivational interviewing plus motivational incentives (MI+) is more effective than Conventional Care (CC) with NICU parents. The effects of MI+ versus CC on household smoking and infant smoke exposure are expected to be mediated via motivation to change and treatment participation. A total of 396 families with an infant at high respiratory risk in the NICU who report a household smoker will be randomized. The MI+ intervention will consist of 4 one-hour counseling sessions (2 in the hospital; 2 in the home post-discharge) and incentives for both session attendance and establishing a home smoking ban. CC will involve written materials that include information about the effects of smoking and cessation tips discussed in meetings with a Family Life Coordinator. Counseling and interviews will be conducted in Spanish and English. Primary efficacy variables will include objective and valid measures of SHSe (infant cotinine, household air nicotine monitors, Timeline Followback for SHSe). Outcomes will be assessed at 1 and 6 months post-intervention using generalized linear mixed models, poisson and logistic regression. This will be the first study of an innovative combination of motivational strategies targeting SHSe within the context of a NICU to improve the health of vulnerable infants and their families, potentially saving millions in healthcare dollars. This trial may also demonstrate a practical means of accessing young, minority and economically disadvantaged families for preventive services, who are unlikely to present to traditional clinics for such care. Highly experienced behavioral and clinical investigators, pilot data suggesting intervention feasibility and promise, a large and accessible population, and an extraordinary infrastructure ensure study success. PUBLIC HEALTH RELEVANCE: Children chronically exposed to secondhand smoke (SHS) have diminished pulmonary function, and are more likely to suffer from respiratory infections, asthma, middle ear disease, poor growth, neurocognitive deficits, and sudden infant death syndrome. Low birth weight infants and infants at high respiratory risk admitted to a neonatal intensive care unit (NICU) are especially vulnerable to the effects of SHS, particularly given the poverty that exists among many NICU families who report a household smoker. Effective interventions to eliminate secondhand smoke exposure (SHSe) initiated in the NICU setting may reduce infant morbidity, mortality, and associated costs, and may reduce tobacco-related disparities in health.