Smoking, Smoking Cessation
Conditions
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.
Interventions
BEHAVIORALComprehensive Relapse Prevention Intervention
This intervention consists of 4 components: 1. Visit Prior to Discharge: counselor from research team will visit patient at hospital bedside to provide counseling 2. Follow up calls after discharge: 6 proactive counseling calls and initiate unlimited reactive calls to their counselor, at days 1,3,7,14,30,an 60 days after hospital visit 3. Text messaging support: patients will be registered in NCI's Smokefree TXT while in the hospital and will receive multiple daily messages, designed for someone who has already quit 4. Caregiver support: 10 minute training session to the caregiver on how to help patient prevent relapse by increasing self efficacy, maintaining motivation and dealing with high risk situations
BEHAVIORALStandard Treatment Counseling
Participants will receive two 10 minute counseling calls from the staff of the preoperative counseling program during the first month after the hospital discharge
DRUGNicotine Replacement Therapy (NRT)
Patients in both arms will be encouraged to receive NRT
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self Reported Relapse Rate for Usual Care Arm | 3 Months | Measured using the modified Dillman method |
| Self Reported Relapse Rate for relapse prevention intervention arm | 3 Months | Measured using the modified Dillman method |
Countries
United States
Outcome results
None listed