Expanding the Role of the Safety Manager to Implement a Workplace Smoking Cessation Program in the Construction Sector
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 608
- 试验地点
- 2
- 主要终点
- Program Cost-Effectiveness Measured by Number of U.S Dollars
研究概览
简要总结
The main objective of this study is to identify the optimal adaptive smoking cessation program for the construction sector in terms of effectiveness, cost-effectiveness, and potential implementation.
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 (Participant)
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
- •Company leaders:
- •≥ 18 years
- •Involved in decision making
- •Willing to participate in the implementation development and evaluation
- •Safety Managers:
- •- ≥ 18 years Self-identified as a safety manager or superintendent Have no plans to leave the company in the next year Speak either English or Spanish Non-cigarette smoker Willing to receive training in smoking cessation treatment Willing to deliver the smoking cessation treatment to workers
- •Construction Workers:
- •Be a construction worker
- •≥ 18 years
- •Have smoked on average 5 or more cigarettes daily for the past year
- •Willing to make a serious quit attempt in the next 30 days
- •Willing to receive treatment from the Florida Tobacco Quitline.
- •Planning to stay in the company for the next 6 months
- •Own a telephone and plan to keep it active for the next 12 months
排除标准
- •Safety Managers:
- •- Current cigarette smoker
研究组 & 干预措施
Phase 1 Group B: Brief Behavioral Counseling Group
Participants will receive one brief behavioral counseling session and two phone call follow-ups, then be followed up for 12 months. Besides the counseling session, they will be provided with Nicotine Replacement Therapy (NRT) and a referral to the TQL.
For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the counseling session. This amount is enough for 3 weeks. An additional 3-week supply will be provided at the second follow-up.
干预措施: Brief Behavioral Counseling (Behavioral)
Phase 2 Group B + C: Brief Counseling and Intensive Behavioral Counseling Group
Participants from Phase 1 Group B who did not quit smoking at the 3-month follow-up may receive four behavioral counseling sessions, two phone-call follow-ups, and Nicotine Replacement Therapy (NRT) and be followed up for 12 months.
For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the first counseling session. This amount is enough for 3 weeks. An additional 3-week supply is provided at the fourth session.
干预措施: Tobacco Quit-line (Behavioral)
Phase 1 Group B: Brief Behavioral Counseling Group
Participants will receive one brief behavioral counseling session and two phone call follow-ups, then be followed up for 12 months. Besides the counseling session, they will be provided with Nicotine Replacement Therapy (NRT) and a referral to the TQL.
For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the counseling session. This amount is enough for 3 weeks. An additional 3-week supply will be provided at the second follow-up.
干预措施: Tobacco Quit-line (Behavioral)
Phase 2 Group A: Second Tobacco Quit-line (TQL) Group
Participants from Group A who did not quit smoking at the 3-month follow-up may receive a second referral to the TQL and will be followed up for up to 12 months.
干预措施: Tobacco Quit-line (Behavioral)
Phase 2 Group B: Second Brief Behavioral Counseling Group
Participants from Group B who did not quit smoking at the 3-month follow-up may receive a second brief behavioral counseling session and two phone call follow-ups, then be followed up for 12 months. Besides the counseling session, they will be provided with Nicotine Replacement Therapy (NRT) and a second referral to the TQL.
For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the counseling session. This amount is enough for 3 weeks. An additional 3-week supply is provided at the second follow-up.
干预措施: Tobacco Quit-line (Behavioral)
Phase 2 Group B: Second Brief Behavioral Counseling Group
Participants from Group B who did not quit smoking at the 3-month follow-up may receive a second brief behavioral counseling session and two phone call follow-ups, then be followed up for 12 months. Besides the counseling session, they will be provided with Nicotine Replacement Therapy (NRT) and a second referral to the TQL.
For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the counseling session. This amount is enough for 3 weeks. An additional 3-week supply is provided at the second follow-up.
干预措施: Brief Behavioral Counseling (Behavioral)
Phase 2 Group A + C: TQL and Intensive Behavioral Counseling Group
Participants from Phase 1 Group A who did not quit smoking at the 3-month follow-up may receive four behavioral counseling sessions, two phone-call follow-ups, and Nicotine Replacement Therapy (NRT) and be followed up for 12 months.
For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the first counseling session. This amount is enough for 3 weeks. An additional 3-week supply is provided at the fourth session.
干预措施: Tobacco Quit-line (Behavioral)
Phase 2 Group A + C: TQL and Intensive Behavioral Counseling Group
Participants from Phase 1 Group A who did not quit smoking at the 3-month follow-up may receive four behavioral counseling sessions, two phone-call follow-ups, and Nicotine Replacement Therapy (NRT) and be followed up for 12 months.
For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the first counseling session. This amount is enough for 3 weeks. An additional 3-week supply is provided at the fourth session.
干预措施: Intensive Behavioral Counseling (Behavioral)
Phase 2 Group B + C: Brief Counseling and Intensive Behavioral Counseling Group
Participants from Phase 1 Group B who did not quit smoking at the 3-month follow-up may receive four behavioral counseling sessions, two phone-call follow-ups, and Nicotine Replacement Therapy (NRT) and be followed up for 12 months.
For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the first counseling session. This amount is enough for 3 weeks. An additional 3-week supply is provided at the fourth session.
干预措施: Brief Behavioral Counseling (Behavioral)
Phase 2 Group B + C: Brief Counseling and Intensive Behavioral Counseling Group
Participants from Phase 1 Group B who did not quit smoking at the 3-month follow-up may receive four behavioral counseling sessions, two phone-call follow-ups, and Nicotine Replacement Therapy (NRT) and be followed up for 12 months.
For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the first counseling session. This amount is enough for 3 weeks. An additional 3-week supply is provided at the fourth session.
干预措施: Intensive Behavioral Counseling (Behavioral)
Phase 1 Group B: Brief Behavioral Counseling Group
Participants will receive one brief behavioral counseling session and two phone call follow-ups, then be followed up for 12 months. Besides the counseling session, they will be provided with Nicotine Replacement Therapy (NRT) and a referral to the TQL.
For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the counseling session. This amount is enough for 3 weeks. An additional 3-week supply will be provided at the second follow-up.
干预措施: Nicorette (Drug)
Phase 2 Group B + C: Brief Counseling and Intensive Behavioral Counseling Group
Participants from Phase 1 Group B who did not quit smoking at the 3-month follow-up may receive four behavioral counseling sessions, two phone-call follow-ups, and Nicotine Replacement Therapy (NRT) and be followed up for 12 months.
For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the first counseling session. This amount is enough for 3 weeks. An additional 3-week supply is provided at the fourth session.
干预措施: Nicorette (Drug)
Phase 2 Group A + C: TQL and Intensive Behavioral Counseling Group
Participants from Phase 1 Group A who did not quit smoking at the 3-month follow-up may receive four behavioral counseling sessions, two phone-call follow-ups, and Nicotine Replacement Therapy (NRT) and be followed up for 12 months.
For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the first counseling session. This amount is enough for 3 weeks. An additional 3-week supply is provided at the fourth session.
干预措施: Nicorette (Drug)
Phase 2 Group B: Second Brief Behavioral Counseling Group
Participants from Group B who did not quit smoking at the 3-month follow-up may receive a second brief behavioral counseling session and two phone call follow-ups, then be followed up for 12 months. Besides the counseling session, they will be provided with Nicotine Replacement Therapy (NRT) and a second referral to the TQL.
For the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the counseling session. This amount is enough for 3 weeks. An additional 3-week supply is provided at the second follow-up.
干预措施: Nicorette (Drug)
Phase 1 Group A: Tobacco Quit-line (TQL) Group
Participants will be referred to the TQL and will be followed up for up to 12 months.
干预措施: Tobacco Quit-line (Behavioral)
结局指标
主要结局
Program Cost-Effectiveness Measured by Number of U.S Dollars
时间窗: Up to 4 years
Will be measured as the difference in the number of U.S. dollars between the three programs.
Program Effectiveness Measure in Percentage
时间窗: Up to 4 years
Will be collected as the difference in percentage of participants who quit smoking at the 12-month follow-up assessment between the three treatment groups.
Program Cost-Effectiveness Measured by Quality Adjusted Life Years
时间窗: Up to 4 years
Will be measured by quality-adjusted life years defined as the difference in the number of years lived in perfect health between the three programs.
次要结局
- Program's Implementation- Feasibility Measured by Likert Scale(Up to 4 years)
- Program's Implementation- Sustainability Measured by Likert Scale(Up to 4 years)
- Program's Implementation- Acceptability Measured by Likert Scale(Up to 4 years)
研究者
Taghrid Asfar
Professor
University of Miami