Preventing Smoking Relapse After Total Joint Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Self Reported Relapse Rate for relapse prevention intervention arm
研究概览
简要总结
Hospitalization for elective knee or hip replacement surgery presents an outstanding opportunity to motivate people to quit smoking, because it provides an opportunity to encourage patients to remain smoke-free as they proactively quit to optimize their surgery outcomes. This study will conduct a comparative effectiveness trial of patients who quit smoking pre-operatively, comparing the current standard of care with a novel comprehensive relapse prevention intervention guided by Marlatt's Relapse Prevention Model.
详细描述
The specific aims of this study are to evaluate the effectiveness and cost-effectiveness of the relapse prevention intervention and will: 1) compare the effectiveness of standard post-operative cessation treatment with a comprehensive relapse prevention intervention on smoking cessation outcomes; 2) conduct a comparative economic analysis to assess the value of the relapse prevention intervention for patients and the healthcare system; and 3) explore the impact of the interventions on surgical complications and readmissions.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Participants
- •Received preoperative smoking cessation counseling through Orthopedic Surgery Quit Smoking Program
- •Undergoing elective knee or hip arthroplasty surgery
- •Have not smoked any cigarettes in the week prior to admission and carbon monoxide 4 ppm46,47
- •Have a cell phone (for text messaging)
- •Provide informed consent in English
- •Caregiver participants:
- •Age ≥ 18 years
- •Be a caregiver of the patient participant
- •Provide informed consent in English
排除标准
- •Patients will be excluded if they used smokeless tobacco or an electronic cigarette in the last 30 days.
研究组 & 干预措施
Standard treatment
Patients will receive current usual care.
干预措施: Standard Treatment Counseling (Behavioral)
Intervention Group
Participants randomized to the Intervention Arm will receive counseling that includes:
- A Visit prior to discharge
- Follow up calls after discharge
- Text Messaging Support
- Caregiver Support
干预措施: Comprehensive Relapse Prevention Intervention (Behavioral)
Standard treatment
Patients will receive current usual care.
干预措施: Nicotine Replacement Therapy (NRT) (Drug)
Intervention Group
Participants randomized to the Intervention Arm will receive counseling that includes:
- A Visit prior to discharge
- Follow up calls after discharge
- Text Messaging Support
- Caregiver Support
干预措施: Nicotine Replacement Therapy (NRT) (Drug)
结局指标
主要结局
Self Reported Relapse Rate for relapse prevention intervention arm
时间窗: 12 Months
Measured using the modified Dillman method
Self Reported Relapse Rate for Usual Care Arm
时间窗: 12 Months
Measured using the modified Dillman method
次要结局
未报告次要终点