Designing a smoking cessation intervention for the unique needs of homeless persons: a community-based randomized clinical trial.
Designing a smoking cessation intervention for the unique needs of homeless persons: a community-based randomized clinical trial.
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DOI：
10.1177/1740774511423947
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发表时间：
2011-12
期刊：
影响因子：
--
通讯作者：
Okuyemi KS
中科院分区：
文献类型：
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作者：
Goldade K;Whembolua GL;Thomas J;Eischen S;Guo H;Connett J;Des Jarlais D;Resnicow K;Gelberg L;Owen G;Grant J;Ahluwalia JS;Okuyemi KS
尽管无家可归者的吸烟率仍然很高(约70%，是美国全国平均水平的三倍)，但戒烟研究通常将无家可归者排除在外。对于这一高风险的吸烟者群体，需要新的循证干预措施。描述首次在无家可归者中进行的戒烟临床试验的目的和设计。这项研究是一项基于社区的两组随机试验，招募了居住在明尼苏达州八个无家可归者收容所和过渡性住房单元的参与者(n=430)。这项研究的目的是测试动机访谈(MI)在提高尼古丁替代疗法(NRT；尼古丁贴片)的依从性和戒烟效果方面的有效性。参与者被随机分为两组：活动组(8周的NRT+6次MI)或对照组(NRT+标准护理)。参与者在6个月的时间里参加了6次面对面评估会议和8次在他们选择的地点进行的保留访问。在为期26周的试验的前8周，尼古丁贴片在4次就诊时给予2周剂量的尼古丁贴片。主要结果是在6个月时可替宁验证的7天点流行戒断。次要结果包括通过直接观察和贴片计数评估尼古丁贴片的依从性。其他结果包括共病精神障碍和药物滥用障碍的调解和/或缓解作用。从以社区为基础的戒烟随机试验中吸取的经验教训包括：(1)通过成立和召开社区咨询委员会，吸收庇护所领导的观点的重要性；(2)将研究设在庇护所，以便参与者更能看到和更容易进入；(3)最大限度地减少排除标准，以便纳入患有稳定精神疾病的参与者；(4)将符合资格的探视的基线访问推迟一周，以防止人员流失；以及(5)使用手机和庇护所特有的沟通渠道，定期和持续地打电话提醒参与者即将到来的预约。这项研究的局限性包括由于样本来自美国中西部的一个城市而导致的概括性。由于纳入标准包括使用NRT贴片的意愿，所有参与者都有动力，并在研究登记时准备戒烟。来自自选小组的研究结果将只适用于那些有动力并准备戒烟的人。高激励措施可能会限制干预的可复制程度。吸取的经验教训反映了需要让社区参与设计和实施以社区为基础的针对弱势人群的临床试验。
Although smoking prevalence remains strikingly high in homeless populations (~70% and three times the US national average), smoking cessation studies usually exclude homeless persons. Novel evidence-based interventions are needed for this high-risk subpopulation of smokers. To describe the aims and design of a first-ever smoking cessation clinical trial in the homeless population. The study was a two-group randomized community-based trial that enrolled participants (n = 430) residing across eight homeless shelters and transitional housing units in Minnesota. The study objective was to test the efficacy of motivational interviewing (MI) for enhancing adherence to nicotine replacement therapy (NRT; nicotine patch) and smoking cessation outcomes. Participants were randomized to one of the two groups: active (8 weeks of NRT + 6 sessions of MI) or control (NRT + standard care). Participants attended six in-person assessment sessions and eight retention visits at a location of their choice over 6 months. Nicotine patch in 2-week doses was administered at four visits over the first 8 weeks of the 26-week trial. The primary outcome was cotinine-verified 7-day point-prevalence abstinence at 6 months. Secondary outcomes included adherence to nicotine patch assessed through direct observation and patch counts. Other outcomes included the mediating and/or moderating effects of comorbid psychiatric and substance abuse disorders. Lessons learned from the community-based cessation randomized trial for improving recruitment and retention in a mobile and vulnerable population included: (1) the importance of engaging the perspectives of shelter leadership by forming and convening a Community Advisory Board; (2) locating the study at the shelters for more visibility and easier access for participants; (3) minimizing exclusion criteria to allow enrollment of participants with stable psychiatric comorbid conditions; (4) delaying the baseline visit from the eligibility visit by a week to protect against attrition; and (5) regular and persistent calls to remind participants of upcoming appointments using cell phones and shelter-specific channels of communication. The study’s limitations include generalizability due to the sample drawn from a single Midwestern city in the United States. Since inclusion criteria encompassed willingness to use NRT patch, all participants were motivated and were ready to quit smoking at the time of enrollment in the study. Findings from the self-select group will be generalizable only to those motivated and ready to quit smoking. High incentives may limit the degree to which the intervention is replicable. Lessons learned reflect the need to engage communities in the design and implementation of community-based clinical trials with vulnerable populations.