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临床试验/NCT01714323
NCT01714323已完成不适用

Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers

Massachusetts General Hospital6 个研究点 分布在 1 个国家目标入组 1,359 人开始时间: 2012年12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
入组人数
1,359
试验地点
6
主要终点
Tobacco Abstinence - 6 Month Follow-up

研究概览

简要总结

Cigarette smoking is the leading preventable cause of death in the U.S. The 2008 US Public Health Service Smoking Cessation Guideline recommends offering effective treatment to smokers in all health care settings, including hospitals. Nearly 4 million smokers are hospitalized each year, and hospital admission offers a "teachable moment" for intervention. Hospital-initiated smoking cessation intervention is effective, but only if contact continues for more than 1 month after discharge. The challenge is to translate this research into clinical practice by identifying an evidence-based cost-effective model that U.S. hospitals can adopt. The major barrier is sustaining contact after discharge. This project tests an innovative strategy to streamline the delivery and maximize the uptake of post-discharge smoking interventions.

Specific Aim: To test the effectiveness of an innovative strategy to maximize smokers' use of evidence-based tobacco treatment (counseling and medication) after hospital discharge, thereby increasing the proportion of smokers who achieve long-term (6-month) tobacco abstinence.

Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll 1350 adult smokers admitted to 3 acute care hospitals in Massachusetts and Pennsylvania. All subjects will receive a brief in-hospital smoking intervention and be randomly assigned at discharge to either Standard Care (passive referral to their state quitline) or Extended Care, a 3-month program consisting of (1) Free Medication: A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider. IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.

Outcomes, assessed at 1, 3, and 6 months after hospital discharge, are: (1) intervention effectiveness (cotinine-validated 7-day point-prevalence tobacco abstinence rate at 6 month follow-up [primary outcome] and other tobacco abstinence measures); (2) treatment utilization, and (3) cost-effectiveness (cost per quit). Exploratory analyses will examine the intervention's effect on hospital readmissions and mortality in the 6 months after discharge.

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

  • Cigarette smoker (smoked at least 1 cigarette in the month before hospital admission and at least 1 cigarette per day when smoking at baseline rate in the month before hospital admission)
  • Counseled by hospital smoking counselor during hospital stay
  • Plans to stop smoking tobacco products after hospital discharge
  • Agrees to take home a supply of smoking cessation medication after discharge
  • Agrees to and able to accept telephone calls after hospital discharge

排除标准

  • No access to a telephone or unable to communicate by telephone
  • Severe psychiatric or neurologic disease precluding ability to provide informed consent and to be counseled
  • Pregnant, nursing, or planning to become pregnant in next 3 months
  • Unable to speak English
  • Medical instability precluding study participation

研究组 & 干预措施

Standard care

Other

At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.

干预措施: Standard Care (Behavioral)

Sustained Care

Experimental

A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.

干预措施: Sustained Care (Behavioral)

结局指标

主要结局

Tobacco Abstinence - 6 Month Follow-up

时间窗: 6 months

Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up

次要结局

  • Point Prevalence Tobacco Abstinence(1 month, 3 months, 6 months)
  • Duration of Tobacco Abstinence After Hospital Discharge(1 month, 3 months, 6 months)
  • Continuous Tobacco Abstinence(1 month, 3 months, 6 months)
  • Use of Smoking Cessation Treatment After Hospital Discharge(1 month, 3 months, 6 months)

研究者

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

Nancy A. Rigotti

Professor of Medicine

Massachusetts General Hospital

研究点 (6)

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