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临床试验/NCT02428244
NCT02428244已完成不适用

Let's STOP Now Trial: Smoking in Trauma Orthopaedic Patients. A Prospective Randomized Trial

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 269 人开始时间: 2014年11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
269
试验地点
2
主要终点
Change in 7-day abstinence point prevalence at 6 weeks

研究概览

简要总结

It is well known that smoking has deleterious effects to fracture/broken bone outcomes. Complications associated with smoking can be mitigated by smoking cessation. Initiating smoking cessation programs while patients are in the inpatient hospital setting has shown to be an opportune time to enroll patients in a smoking cessation program. The goal of this study is to determine if inpatient smoking counseling with/without follow-up is superior to the standard smoking cessation information associated with admission to a hospital facility.

详细描述

Patients who elect to be enrolled in the study will receive an initial enrollment survey (attached, Initial Survey) and baseline exhaled carbon monoxide (see below) and be in one of three arms. The arms in brief include (1) standard of care with research follow-up (as mentioned in the below protocol, control arm), (2) standard of care + a 10-30 minute discussion while an inpatient in the hospital regarding the negative effects of smoking with regards to their traumatic injury with research follow-up, and finally (3) standard of care + a 10-30 minute discussion while an inpatient in the hospital regarding the negative effects of smoking with regards to their traumatic injury with research follow-up and follow-up with the investigators smoking educator.

Participants in arms 2 and 3 will receive their education session at the time of enrollment. Research follow-up (as outlined below) will be conducted at the time of normal clinic visits (to avoid unnecessary visits by the patient for the purposes of research), or over the phone if the patient is unable to make the appointment. Arm 3, which includes 'follow-up with the investigators smoking educator' will receive follow-up with the smoking educator at the time of their research follow-up, eliminating the need for additional visits.

Descriptions of arms:

Arm 1, Control: Standard of care intervention: All patients at the University as a standard of care receive informational materials about smoking cessation. They are referred to the patient resource center. The brochure/document that patients are given which details the resources available is standardized. Patients will be provided this, also they will be provided with a Quitline Brochure.

Arm 2, Standard of care + brief counseling: Patients who are randomized into this arm will receive the standard of care (outlined above). Additionally, patients will also receive a smoking education/counseling session. Patients will receive 10-30 minutes of guided discussion regarding the risks and benefits with regards to smoking and the healing of their traumatic injuries. The smoking educators, who will be trained in accordance with the guidelines provided by MdQuit.org will utilize motivational interviewing techniques to enhance interest in quitting. Patients will receive a description of the quitline, and the quitlined will be the recommended resource. If patients elect to enroll in the quitline, they will be consented using the standardized quitline consent/referral form .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Active smoker (defined as having smoked some days or every day within the last six months
  • Identifying with having some interest in quitting smoking
  • Sustained an orthopaedic injury requiring surgery
  • Age 18 or older
  • Following up at our institution
  • Ability to consent within 3 weeks of first operative intervention
  • Anticipated acute hospital discharge before first follow-up (2-3 weeks)
  • Cognitive ability to consent

排除标准

  • Age 80 or older
  • Cognitive Inability to consent
  • Having previously utilized the Maryland Quitline
  • Not having a reliable phone line (i.e. conventional land line or cell phone)
  • Inability or refusal to follow-up at the designated follow-up time points

研究组 & 干预措施

Arm 1, Control

No Intervention

Standard of care intervention: All patients at the University as a standard of care receive informational materials about smoking cessation. They are referred to the patient resource center at our institution. Patients will be provided this, also they will be provided with a smoking cessation Quitline Brochure

Standard of care + brief counseling

Experimental

Patients who are randomized into this arm will receive the standard of care (outlined above). Additionally, patients will also receive a smoking education/counseling session. Patients will receive 10-30 minutes of guided discussion regarding the risks and benefits with regards to smoking and the healing of their traumatic injuries. The smoking educators, who will be trained in accordance with the guidelines provided by MdQuit.org will utilize motivational interviewing techniques to enhance interest in quitting. Patients will receive a description of the quitline, and the quitlined will be the recommended resource. If patients elect to enroll in the quitline, they will be consented using the standardized quitline protocols.

干预措施: Motivational Interviewing (Behavioral)

Standard of care + counseling/follow-up

Experimental

Patients who are randomized into this arm will receive the same intervention as patients in Arm 2, except when patients arrive for their follow-up, the smoking educator will "check-in" with their progress for approximately 5 minutes. The techniques utilized during this check-in visit will include repetition of previously described motivational interviewing, at this point patients who elect to be referred to the quitline will be given this opportunity.

干预措施: Motivational Interviewing + Follow-up (Behavioral)

结局指标

主要结局

Change in 7-day abstinence point prevalence at 6 weeks

时间窗: 6 weeks

Self-reported 7-day abstinence from smoking at 6 weeks

Change in 7-day abstinence point prevalence at 3 months

时间窗: 3 months

Self-reported 7-day abstinence from smoking at 3 months

Change in 7-day abstinence point prevalence at 2 weeks

时间窗: 2 weeks

Self-reported 7-day abstinence from smoking at 2 weeks

Change in 7-day abstinence point prevalence at 6 months

时间窗: 6 months

Self-reported 7-day abstinence from smoking at 6 months

次要结局

  • Change in Use of the Quitline at 2 weeks(2 weeks)
  • Change in Use of the Quitline at 3 months(3 months)
  • Change in Use of the Quitline at 6 weeks(6 weeks)
  • Change in Exhaled Carbon Monoxide at 2 weeks(2 week)
  • Change in Exhaled Carbon Monoxide at 6 months(6 months)
  • Change in Use of the Quitline at 6 months(6 months)
  • Change in Exhaled Carbon Monoxide at 6 weeks(6 weeks)
  • Change in Exhaled Carbon Monoxide at 3 months(3 months)

研究者

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

Robert O'Toole

Division Chief, Orthopaedic Trauma, Department of Orthopaedics

University of Maryland, Baltimore

研究点 (2)

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