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临床试验/NCT01691105
NCT01691105已完成不适用

Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers

Yale University2 个研究点 分布在 1 个国家目标入组 1,044 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,044
试验地点
2
主要终点
Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence

研究概览

简要总结

This study will implement and test the effectiveness and cost-effectiveness of a tobacco cessation intervention (Academic Detailing + Integrated Tobacco Order Set - AD + ITOS) for adults admitted to the hospital. The intervention will begin during the hospital stay and continue after discharge. The intervention will use resources easily available to most acute care hospitals: computerized physician order entry, physician and nurse education, staff meetings for physicians, nurses and allied health professionals, online learning capabilities, faxing to primary care providers (PCPs), and the telephone counseling and support available from a state smokers' quitline (QL).

The investigators hypothesize that the subjects in the intervention arm (AD + ITOS) will be more likely to achieve tobacco abstinence at 12 months post hospital stay than subjects in the control arm (Academic Detailing - AD). Tobacco abstinence will be assessed by self report and biochemical verification (exhaled carbon monoxide reading).

详细描述

Cigarette smoking remains the leading cause of preventable death and illness in the United States. In 2008, 20.6% of all American adults smoked, and 435,000 died from smoking-related illnesses. Economic costs of smoking dependence are estimated at $193 billion/year and have far-reaching implications for the individual, workplace, society and the healthcare system. However, treatment is associated with significant individual and society benefits, and both counseling and pharmacotherapy have been demonstrated to be effective treatments. Along with poverty and low education, smoking causes a greater loss of quality-adjusted life years than race, uninsurance, overweight, or binge drinking.

Smokers are admitted to acute care hospital more than nonsmokers. Using estimates from a number of sources, we estimate that approximately 6.1-12.5 million hospitalizations occur annually among adult smokers. This represents 20-41% of the 29.8 million annual inpatient stays in US acute care hospitals among adults age 18 and older unrelated to pregnancy or childbirth. Put another way, the nation's 46 million smokers represent 20% of the adult population, but account for 20-40% of all hospitalizations unrelated to pregnancy. Given that US hospitals are now smoke-free (per Joint Commission regulations), and many of these admissions are for tobacco-related conditions, the hospital admission represents a profound opportunity-a "teachable moment"-for tobacco control.

Recent "core measure" regulations by the Joint Commission and the Centers for Medicare and Medicaid Services require hospitals to report publicly their tobacco screening for patients admitted with acute myocardial infarction, congestive heart failure, and pneumonia. Although many hospitals have improved their performance considerably on these smoking measures, sometimes this has resulted from "gaming," e.g. giving all discharged patients a preprinted instruction sheet that includes boilerplate text about smoking cessation. Thus, although most hospitals assess inpatients for tobacco use (either through a nursing assessment or the physician's initial history and physical examination), there are often no systems in place to initiate or sustain tobacco treatment for smokers. This gap in service delivery prevents millions of smokers from accessing the many effective, evidence-based treatments for tobacco dependence during a period in which they may be particularly receptive to an intervention.

Hence, the overarching goal of this project is to implement and study the effectiveness and cost-effectiveness of a tobacco intervention for hospitalized adults that begins during inpatient treatment and continues after discharge. To enhance dissemination, we will use resources currently available to most acute care hospitals: computerized physician order entry, physician and nurse education, staff meetings for physicians, nurses, and allied health professionals, online learning capabilities, faxing to primary care providers (PCPs), and the telephone counseling and support available from a state smokers' quitline (QL). In the final year, a toolkit will be disseminated by professional societies. We hypothesize that the proposed intervention is clinically effective, cost effective, sustainable, and generalizable. All interventions are evidence-based and consistent with the 2008 Public Health Service clinical practice guideline for tobacco dependence treatment.

The Specific Aims of the proposed project are to:

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
Single (Investigator)

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
  • admitted to any medical ward, telemetry or cardiac care unit
  • identified as a smoker by the nurse or physician in the admitting EMR
  • treated by a study physician
  • able to give written informed consent

排除标准

  • inability to read or understand English or Spanish
  • lacks capacity to give informed consent
  • currently receiving formal tobacco dependence treatment
  • current suicide or homicide risk
  • current psychotic disorder or life-threatening or unstable medical or psychiatric condition within past 6 months
  • unable to provide 2 telephone contact numbers
  • unwilling to follow up per study protocol, including release of information to assess treatment engagement at 30-days
  • live outside of New Haven County
  • leaving the hospital against medical advice
  • history of clinically significant allergic reaction to nicotine replacement therapies, varenicline or bupropion
  • use of an investigational drug within 30 days
  • use of tobacco products other than cigarettes
  • women of childbearing potential who are pregnant, nursing, or sexually active and not practicing effective contraception (oral injectable, or implantable contraceptives, intrauterine device, or barrier method with spermicide)
  • do not have access to a phone with a CT area code (required to use the CT Tobacco Quitline)

结局指标

主要结局

Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence

时间窗: 12 months post enrollment

Tobacco abstinence will be assessed by obtaining an exhaled carbon monoxide reading for all subjects self-reporting tobacco abstinence at 12 month follow-up. Consistent with manufacturer's recommendations, a cutoff of 10 ppm will indicate current smoking.

次要结局

  • Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 12 Months(12 months post enrollment)
  • Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 6 Months(6 months post enrollment)
  • Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 1 Month(1 month post enrollment)
  • Number of Participants Self-Reporting Treatment Engagement - 1 Month(1 month post enrollment)
  • Number of Participants Self-Reporting Use of Cessation Medications - 1 Month(1 month post enrollment)
  • Number of Participants Self-Reporting Use of Cessation Medications - 6 Months(6 months post enrollment)
  • Number of Participants Self-Reporting Use of Cessation Medications - 12 Months(12 months post enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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