Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,416
- 试验地点
- 3
- 主要终点
- Tobacco Abstinence, Biochemically Confirmed
研究概览
简要总结
This randomized controlled trial will compare the effectiveness of two models of post-discharge tobacco cessation treatment for adult smokers admitted to 3 U.S. hospitals.
详细描述
This multi-site randomized controlled trial (RCT) will compare the effectiveness of two models of post-discharge tobacco cessation treatment for adult smokers who are admitted to 3 large hospital systems in 3 U.S. regions (MA, PA, TN). All patients will receive guideline-based tobacco cessation treatment delivered in hospital by each site's existing Tobacco Treatment Service that is directed by a study investigator. Patients who plan to quit smoking after hospital discharge will be randomly assigned to 1 of 2 post-discharge tobacco treatment interventions and followed at 1, 3, and 6 months. One arm uses bidirectional electronic referral (eReferral) to the state tobacco quitline. The other arm, Personalized Tobacco Care Management (PTCM), combines proactive messages delivered by automated interactive voice response (IVR) phone calls, text messaging, and/or email with health coaching provided by a hospital-based tobacco counselor. Both groups will receive at least 1 month of nicotine replacement therapy.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Current cigarette smoker (>=1 cigarette in the week before admission and >=1 cigarette/day when smoking at a baseline rate in the month prior to admission)
- •Admitted to a study hospital
- •Seen by hospital smoking counselor during inpatient stay
- •Plans to try to quit smoking after hospital discharge
排除标准
- •Inability to give informed consent or participate in counseling due to serious cognitive or psychiatric disorder (e.g., dementia, psychosis)
- •Life expectancy <12 months
- •Medical instability
- •No reliable telephone access or inability to use telephone
- •Non-English speaking
- •Pregnant, breastfeeding, to planning to become pregnant in the next 6 months.
研究组 & 干预措施
Transitional Tobacco Care Management (TTCM)
TTCM will provide 8 weeks of nicotine replacement therapy at hospital discharge and proactive contacts over 3 months delivered by automated IVR call. At each contact the patient is offered a return call from the hospital-based tobacco coach for counseling, medication advice, and coordination of care with the patient's outpatient health care team.
干预措施: Transitional Tobacco Care Management (TTCM) (Behavioral)
Transitional Tobacco Care Management (TTCM)
TTCM will provide 8 weeks of nicotine replacement therapy at hospital discharge and proactive contacts over 3 months delivered by automated IVR call. At each contact the patient is offered a return call from the hospital-based tobacco coach for counseling, medication advice, and coordination of care with the patient's outpatient health care team.
干预措施: Nicotine replacement therapy (Drug)
eReferral to State Tobacco Quitline (QL)
Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Quitline staff will contact patient to offer up to 5 proactive telephone calls from a tobacco coach. Patient may also be eligible for NRT sample. Feedback from the quitline will be sent back to the patient's medical chart.
干预措施: eReferral to State Tobacco Quitline (QL) (Behavioral)
eReferral to State Tobacco Quitline (QL)
Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Quitline staff will contact patient to offer up to 5 proactive telephone calls from a tobacco coach. Patient may also be eligible for NRT sample. Feedback from the quitline will be sent back to the patient's medical chart.
干预措施: Nicotine replacement therapy (Drug)
结局指标
主要结局
Tobacco Abstinence, Biochemically Confirmed
时间窗: 6 months after hospital discharge
Participant self-report of no use of any tobacco product (cigarettes, cigars, little cigars, pipes, smokeless tobacco product) in the past 7 days AND either a saliva sample with a cotinine concentration \<=10 ng/ml OR breath sample with a carbon monoxide concentration \<=9 ppm.
次要结局
- Tobacco Abstinence, Self-report(6 months after hospital discharge)
- Engagement in Cessation Treatment(3 months after hospital discharge)
- Self-reported Continuous Tobacco Abstinence Since Hospital Discharge(6 months follow-up)
研究者
Nancy A. Rigotti
Professor of Medicine
Massachusetts General Hospital