Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans
2015年4月6日 更新者:US Department of Veterans Affairs
The primary objective of this study is to determine whether a nurse-initiated intervention, which couples brief inpatient counseling and proactive telephone counseling by a centralized tobacco quitline, improves 6-month cessation rates in hospitalized VA smokers.
If proven effective, the proposed intervention will provide a practical strategy to enhance the adoption and implementation of recommended smoking cessation procedures in VA hospitals, and will demonstrate the utility of quitlines in preventing relapse in hospitalized smokers once they leave the hospital.
研究概览
详细说明
Although the majority of hospitalized VA smokers receive some form of cessation counseling during hospitalization, few receive outpatient cessation counseling and/or pharmacotherapy following discharge, which are key factors associated with long-term cessation.
The primary objective of this research study is to determine whether a nurse-initiated intervention, which couples brief inpatient counseling and proactive telephone counseling by a centralized tobacco quitline, improves 6-month cessation rates in hospitalized VA smokers.
Co-primary aims are to determine whether the intervention improves the prescription of recommended pharmacotherapy for smoking cessation and the referral of patients for telephone counseling (or other outpatient cessation counseling).
We will perform a quasi-experimental before-after trial in hospitalized patients, aged 18 or older, who smoke at least one cigarette per day on average.
After a 6-month baseline period, we will implement the intervention and enroll a separate cohort of patients over the subsequent 6 months.
The intervention will include: 1) nurse training in delivery of bedside cessation counseling, 2) use of CPRS-based practice tools (to streamline nursing assessment and documentation, to facilitate prescription of pharmacotherapy), 3) computerized referral of motivated inpatients for proactive telephone counseling, and 4) use of nursing peer leaders to provide coaching and performance feedback to ward nurses.
Enrolled patients will be contacted by telephone at 3 and 6 months to assess 7-day point prevalence abstinence and prolonged abstinence (with biochemical confirmation of self-reported quitters at 6 months).
We will identify barriers and facilitators to implementation by using clinician focus groups, and will assess attitudes of staff nurses toward cessation counseling by questionnaire.
We will also conduct semi-structured interviews in a subsample of patients and nurses to assess perceptions of the intervention, and will use content analysis to interpret the data.
研究类型
介入性
注册 (实际的)
898
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Colorado
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Denver、Colorado、美国、80220
- VA Eastern Colorado Health Care System, Denver, CO
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Iowa
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Iowa City、Iowa、美国、52246-2208
- Iowa City VA Health Care System, Iowa City, IA
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Minnesota
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Minneapolis、Minnesota、美国、55417
- Minneapolis VA Health Care System, Minneapolis, MN
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Nebraska
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Omaha、Nebraska、美国、68105-1873
- VA Medical Center, Omaha
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients: The study sample will include general medical inpatients, aged 18 or older, who smoke at least one cigarette per day on average, regardless of their willingness to quit smoking. To increase applicability of study results, the goal is to enroll patients with characteristics that reflect the full range and distribution of patients observed in clinical practice. Current smokers transferred from intensive care units (or other monitored beds) to a general medical ward will be eligible.
- Nurses: The study sample will include staff nurses who are assigned to a general medicine inpatient unit at one of the participating sites.
Exclusion Criteria:
- Hospitalization for less than 18 hours (e.g., patients admitted for overnight observation);
- Acute medical decomposition (e.g., acute respiratory failure requiring intubation, cardiac arrest, septic shock);
- Altered mental status;
- Unstable psychiatric disorder (e.g., acute psychosis);
- Dementia;
- Communication barrier (unable to speak English, hard of hearing, aphasic);
- Pregnancy;
- Terminal illness (<12 month life expectancy);
- No access to a phone or the absence of a permanent address;
- Admitted for treatment of substance abuse.
No patient will be included unless they are able to provide informed consent and agree to be contacted by telephone during follow-up (to assess smoking status).
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:Arm 1
Baseline Period
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实验性的:Arm 2
Intervention Period
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1. Enhanced academic detailing of staff nurses (face-to-face training, feedback on group performance, and periodic check-ins with both nurse managers and peer leaders); 2. Adaptation of the computerized information system (modified nursing admission database that includes pertinent questions about smoking, computerized "quick orders" for smoking cessation medications), 3) Patient self-management support (self-help materials, fax referral of motivated patients to state quit line), and 4) nursing peer leaders on each study unit.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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7-day Point-prevalence Smoking Abstinence (6-month)
大体时间:6 months post enrollment
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This is the number of patients who reported not have smoked cigarettes over the 7 days prior to the 6-month follow-up interview.
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6 months post enrollment
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Referrals to Quitline
大体时间:Assessed within 72 hours of hospital discharge
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Assessed within 72 hours of hospital discharge
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Prescription of Recommended Pharmacotherapy for Smoking Cessation
大体时间:Assessed within 72 hours of hospital discharge
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Assessed within 72 hours of hospital discharge
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:David A. Katz, MD MSc、Iowa City VA Health Care System, Iowa City, IA
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Katz DA, Holman J, Johnson S, Hillis SL, Ono S, Stewart K, Paez M, Fu S, Grant K, Buchanan L, Prochazka A, Battaglia C, Titler M, Vander Weg MW. Implementing smoking cessation guidelines for hospitalized veterans: effects on nurse attitudes and performance. J Gen Intern Med. 2013 Nov;28(11):1420-9. doi: 10.1007/s11606-013-2464-7. Epub 2013 May 7.
- Kamath AS, Vaughan Sarrazin M, Vander Weg MW, Cai X, Cullen J, Katz DA. Hospital costs associated with smoking in veterans undergoing general surgery. J Am Coll Surg. 2012 Jun;214(6):901-8.e1. doi: 10.1016/j.jamcollsurg.2012.01.056. Epub 2012 Apr 11.
- Katz D, Vander Weg M, Fu S, Prochazka A, Grant K, Buchanan L, Tinkelman D, Reisinger HS, Brooks J, Hillis SL, Joseph A, Titler M. A before-after implementation trial of smoking cessation guidelines in hospitalized veterans. Implement Sci. 2009 Sep 10;4:58. doi: 10.1186/1748-5908-4-58.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年5月1日
初级完成 (实际的)
2013年6月1日
研究完成 (实际的)
2013年8月1日
研究注册日期
首次提交
2008年12月29日
首先提交符合 QC 标准的
2008年12月30日
首次发布 (估计)
2008年12月31日
研究记录更新
最后更新发布 (估计)
2015年4月27日
上次提交的符合 QC 标准的更新
2015年4月6日
最后验证
2014年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.