Phone-Based Postpartum Continuing Care: Smoking Cessation Beginning in Pregnancy

描述（由申请人提供）：绝大多数在怀孕期间戒烟的妇女在产后前六个月复发，这突出表明需要有效的产后持续护理，以支持妇女度过具有挑战性的产后时期，此时压力很大，保持戒烟的动力可能会下降。现有的复发预防干预措施（通常在怀孕期间实施）被发现在怀孕期间收效甚微 产后期间，这表明需要一个更正式的持续护理的方法。基于电话的戒烟协议已被广泛传播和有效，因为它们解决了灵活访问的需要，但被动，通常不被产后妇女使用。 拟议的试点研究将开发和测试一种基于电话的产后持续护理（PPCC）模型，该模型借鉴了现有的循证协议-5A和恢复管理检查（RMC）-对其他人群有效。实验性PPCC将通过积极的再干预（即，RMC）与5A的时候，产后妇女更有可能复发，并提供教育和监测婴儿的直接和间接接触尼古丁通过母乳喂养和二手烟。我们将评估PPCC相对于被动转介到24/7热线的有效性，这是目前的标准护理。大约130名在过去一年中依赖尼古丁、目前吸烟或在过去90天内戒烟的怀孕前三个月或中期的妇女将在第一次产前预约时被招募， 位于马里兰州巴尔的摩的马里兰州妇女中心。所有的妇女在怀孕期间都将从她们的医生那里得到诊所的戒烟护理标准--5A。一半将被随机分配到产后6个月接受PPCC的实验组，另一半将被随机分配到产后仅接受被动24/7状态戒烟热线的对照组。预计在分娩后的6个月内，实验性PPCC中的妇女（相对于对照组）将：a）吸烟更少，B）吸烟天数更少，c）产后复发前的时间更长，d）复发和与健康专业人员谈论吸烟之间的时间更短，e）复发和恢复戒烟之间的时间更短，f）母乳喂养时吸烟次数更少，g）与婴儿在同一个房间时少吸烟，h）降低婴儿的可替宁水平。 该试点项目的目的是从现有的循证方法中发展PPCC，证明实施PPCC干预的可行性，每个波至少有80%的依从性和至少80%的随访，并评估与接受标准治疗与标准治疗+ PPCC相关的效应量，以了解更大规模临床试验的承诺和所需的适当把握度。

DESCRIPTION (provided by applicant): The large majority of women who quit smoking during pregnancy relapse in the first six months postpartum, highlighting a need for effective postpartum continuing care that supports women through the challenging postpartum period when stress is high and motivation to stay quit may decline. Existing relapse prevention interventions (typically delivered during pregnancy) have been found to be of little benefit during the postpartum period, suggesting the need for a more formal continuing care approach. Phone-based protocols for smoking cessation have been widely disseminated and effective because they address the need for flexible access, but are passive and not typically utilized by women in the postpartum period. The proposed pilot study will develop and test a Phone-based Postpartum Continuing Care (PPCC) model that draws from existing evidence-based protocols--the 5 A's and Recovery Management Checkups (RMC)-- shown to be effective with other populations. The experimental PPCC will reinforce the importance of abstinence, relapse prevention, and reduced smoking through proactive re-intervention (i.e., RMC) with the 5 A's at times when postpartum women are more likely to relapse, and provide education and monitoring of the infant's direct and indirect exposure to nicotine through breastfeeding and secondhand smoke. We will evaluate PPCC's effectiveness relative to a passive referral to a 24/7 hotline, which is current standard care.., Approximately one hundred thirty women in their first or second trimester of pregnancy who were nicotine-dependent in the past year, currently smoke, or quit within the past 90 days will be recruited at their first prenatal appointment at the Maryland Women's Center (MWC) in Baltimore, Maryland. All women will receive the clinic's standard of care for smoking cessation--the 5 A's --during pregnancy from their physician. Half will be randomly assigned to an experimental group getting PPCC for 6 months postpartum and half to a control group receiving only a referral to a passive 24/7 state quit line postpartum. It s expected that in the 6 months following childbirth women in the experimental PPCC (relative to those in the control group) will: a) smoke fewer cigarettes, b) smoke fewer days, c) go longer before postpartum relapse, d) have less time between relapse and talking to a health professional about smoking, e) have less time between relapse and resumption of abstinence , f) smoke fewer times while breastfeeding, g) smoke fewer times while in the same room as the infant, and h) reduce their infant's cotinine levels. The aims of this pilot project are to develo PPCC from existing evidence-based approaches, demonstrate the feasibility of implementing the PPCC intervention with at least 80% compliance and at least 80% follow-up at each wave, and evaluate the effect size associated with receiving standard care vs. standard care + PPCC in order to understand the promise of and appropriate power required for a larger clinical trial.