Preventing Smoking Relapse After Total Joint Replacement Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Self Reported Relapse Rate for relapse prevention intervention arm
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Patients will be excluded if they used smokeless tobacco or an electronic cigarette in the last 30 days.
Arms & Interventions
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
Intervention: Comprehensive Relapse Prevention Intervention (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
Intervention: Nicotine Replacement Therapy (NRT) (Drug)
Standard treatment
Patients will receive current usual care.
Intervention: Standard Treatment Counseling (Behavioral)
Standard treatment
Patients will receive current usual care.
Intervention: Nicotine Replacement Therapy (NRT) (Drug)
Outcomes
Primary Outcomes
Self Reported Relapse Rate for relapse prevention intervention arm
Time Frame: 12 Months
Measured using the modified Dillman method
Self Reported Relapse Rate for Usual Care Arm
Time Frame: 12 Months
Measured using the modified Dillman method
Secondary Outcomes
No secondary outcomes reported