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临床试验/NCT01289275
NCT01289275已完成4 期

Smoking Cessation in Hospitalized Smokers

University of California, San Diego6 个研究点 分布在 1 个国家目标入组 1,270 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
1,270
试验地点
6
主要终点
Percentage of Participants With 30-day Abstinence

研究概览

简要总结

When smokers are hospitalized they quit smoking, either voluntarily or involuntarily. Most of them, however, go back to smoking soon after discharge. This study will test an innovative approach which includes dispensing nicotine patches at discharge, providing proactive telephone counseling post discharge, or giving a combination of the two. The interventions are aimed at increasing the long term quit rate of these patients.

The specific aims of the study are to demonstrate the effects of two interventions, dispensing nicotine patches at discharge and providing proactive telephone counseling soon after discharge, on 12-month quit rates of hospitalized smokers in a 2 x 2 factorial design.

详细描述

Most smokers in the U.S. actually do quit smoking when hospitalized, either voluntarily or involuntarily because of hospital's nonsmoking policy. However, the majority of them return to smoking soon after their discharge from the hospital. A hospital stay, therefore, is a "teachable moment" for these patients, a good opportunity to encourage them to lead a smoke-free life after they are discharged. Research, however, has found that brief counseling provided to smokers while they are hospitalized has limited effect. The scientific data clearly show that smokers should be identified at the hospital, provided counseling, and given intensive interventions with follow up extended to 1 month post discharge. Providing such clinical services to these patients will reduce their chance of relapse to smoking and the rate of re-hospitalization. In practice though, hospitals have had difficulty providing even basic bedside counseling with a subgroup of patients, not to mention a much longer follow up post-discharge with all patients.

The proposed study aims to demonstrate that state quitlines can help bridge the gap between the recommendations from existing scientific data and the current practice by hospitals. Quitlines deliver counseling services by telephone. This is convenient for patients because they do not have to go anywhere in order to receive the counseling. Moreover, telephone counseling can be delivered proactively by the counselor.

The potential impact of this study is that if this model is proven effective in a rigorous study design, then it is likely that state quitlines across the U.S. will adopt it and start working with hospitals that are interested in using such as system. If the new JCAHO requirements get adopted, there will be a strong incentive for the hospitals to work with partners like the quitlines that can help provide follow up counseling.

With the proposed project the investigators intend to establish a practical model that lends itself to broader dissemination, while testing the effectiveness of the interventions with the rigor of a randomized design.

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

  • 18 years or older
  • Smoke >=6 Cigarettes per day
  • English or Spanish speaking
  • Valid phone number
  • Valid address
  • Gave consent to participate in study and evaluation

排除标准

  • Hospital stay of less than 24 hours
  • Inability to communicate orally
  • Hypersensitivity to nicotine
  • Hospitalized for psychiatric treatment

研究组 & 干预措施

Telephone Counseling

Experimental

Up to 5 proactive counseling sessions

干预措施: Telephone Counseling (Behavioral)

Telephone Counseling

Experimental

Up to 5 proactive counseling sessions

干预措施: Brief Hospital Counseling (Behavioral)

Nicotine Patches

Experimental

8 weeks of nicotine patches

干预措施: Nicotine Patches (Drug)

Nicotine Patches

Experimental

8 weeks of nicotine patches

干预措施: Brief Hospital Counseling (Behavioral)

Telephone Counseling + Patches

Experimental

5 proactive sessions, 8 weeks patches

干预措施: Nicotine Patches (Drug)

Telephone Counseling + Patches

Experimental

5 proactive sessions, 8 weeks patches

干预措施: Telephone Counseling (Behavioral)

Telephone Counseling + Patches

Experimental

5 proactive sessions, 8 weeks patches

干预措施: Brief Hospital Counseling (Behavioral)

Brief hospital counseling

Active Comparator

brief in hospital counseling, no proactive sessions or patches

干预措施: Brief Hospital Counseling (Behavioral)

结局指标

主要结局

Percentage of Participants With 30-day Abstinence

时间窗: 6-months post enrollment

All participants will receive an assessment Interview 6-months after their initial contact with the Helpline. The interview will cover, as appropriate, tobacco use, use of quitting aids, pattern of quitting (including slips and relapse situations), and satisfaction with the services. The interview will be conducted over the telephone. Intention to treat analysis.

次要结局

  • Self-reported Re-hospitalization(6-months post enrollment)
  • 30-day Abstinence(2-months post enrollment)
  • Percentage of Smokers Making a 24-hour Quit Attempt(6-months post enrollment)

研究者

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

Shu-Hong Zhu

Professor

University of California, San Diego

研究点 (6)

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