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临床试验/NCT01063972
NCT01063972已完成不适用

Centralized Disease Management for Rural Hospitalized Smokers

Edward Ellerbeck, MD, MPH2 个研究点 分布在 1 个国家目标入组 606 人开始时间: 2010年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
606
试验地点
2
主要终点
Number of Participants With 7-day Point Prevalence Abstinence From Cigarettes, Validated

研究概览

简要总结

Our long-term goal is to improve smoking cessation treatment for rural smokers. The objective is to assess the effectiveness of a centralized disease management program for hospitalized smokers that coordinates care across treatment settings and links smokers to existing resources. Our central hypothesis is that Centralized Disease Management (CDM) will increase the use of smoking cessation treatments and lead to greater long term smoking cessation than Counseling alone. Demonstrating the effectiveness of a disease management program and identifying the critical components of such a program will provide a basis for improving the utilization of existing smoking cessation resources while enhancing the treatment of rural hospitalized smokers.

详细描述

The proposed study will use a randomized clinical trial design to examine the effectiveness of centralized disease management (CDM) versus counseling alone (C) for smoking cessation. Hospitalized smokers in 30 rural critical access hospitals will be randomly assigned to either CDM (n=303) or C (n=303). Participants in both arms of the study will receive in-hospital smoking cessation counseling via telephone followed by 4 outpatient telephone-based counseling calls. The content and timing of these counseling calls are designed to emulate models of smoking cessation counseling that have been previously shown to be effective for hospitalized smokers. For recipients assigned to CDM, the counseling will be streamlined to allow time on the calls for specific disease management interventions, including screening for contraindications to pharmacotherapy and linking medication choices to the smoker's insurance coverage. After completing calls with CDM participants, the Tobacco Treatment Specialists will coordinate therapy with the patient's health care providers by providing them with brief consultation reports, prepared order sheets for inpatient treatment, and outpatient prescription requests. Six months postdischarge, participants in both groups will be contacted again, and persistent or relapsed smokers will be offered another cycle of the C or CDM intervention.

Assessments will be conducted at baseline and at months 3, 6, and 12. The primary outcome of interest will be biochemically verified 7-day point prevalence abstinence at 12 months. Secondary endpoints include number of quit attempts and number of cigarettes smoked (among continuing smokers), pharmacotherapy utilization, duration of pharmacotherapy utilization, and the extent of discussions with the healthcare provider. We will also examine the marginal cost-effectiveness of the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • Hospitalized in a participating rural hospital
  • Aged 18 years or older
  • Smoke cigarettes on >25 of the last 30 days
  • Have a home address and telephone
  • Willing to participate in phone assessments

排除标准

  • Terminal medical condition with life expectancy <1 year

研究组 & 干预措施

Experimental 1

Experimental

Experimental: 1 Centralized disease management

干预措施: Centralized disease management (CDM) (Behavioral)

Experimental 2

Experimental

Experimental: 2 Counseling alone

干预措施: Counseling (C) (Behavioral)

结局指标

主要结局

Number of Participants With 7-day Point Prevalence Abstinence From Cigarettes, Validated

时间窗: 12 months

Participant-reported 7-day point prevalence abstinence from cigarettes, validated by salivary cotinine (\< 15ng/ml) or proxy. Participants who did not respond to the survey were considered current smokers.

次要结局

  • Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy During First 6 Months(6 months)
  • Number of Participants With 7-day Point Prevalence Abstinence at 6 Months, Self-reported(6 months)
  • Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy Between 6 and 12 Months(12 months)
  • Number of Participants With 7-day Point Prevalence Abstinence at 3 Months, Self-reported(3 months)
  • Number of Participants With 7-day Point Prevalence Abstinence at 12 Months, Self-reported(12 months)

研究者

发起方
Edward Ellerbeck, MD, MPH
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Edward Ellerbeck, MD, MPH

Professor, Chairman Preventive Medicine

University of Kansas Medical Center

研究点 (2)

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