Preventing Smoking Relapse After Total Joint Replacement Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preventing Smoking Relapse After Total Joint Replacement Surgery

Conditions
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Smoking, Smoking Cessation

Intervention / Treatment
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* Behavioral: Comprehensive Relapse Prevention Intervention
* Behavioral: Standard Treatment Counseling
* Drug: Nicotine Replacement Therapy (NRT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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 | Behavioral: Comprehensive Relapse Prevention Intervention<br>* This intervention consists of 4 components: Visit Prior to Discharge: counselor from research team will visit patient at hospital bedside to provide counseling 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 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 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<br>Drug: Nicotine Replacement Therapy (NRT)<br>* Patients in both arms will be encouraged to receive NRT<br>|
| Active Comparator: Standard treatment<br>Patients will receive current usual care. | Behavioral: Standard Treatment Counseling<br>* Participants will receive two 10 minute counseling calls from the staff of the preoperative counseling program during the first month after the hospital discharge<br>Drug: Nicotine Replacement Therapy (NRT)<br>* Patients in both arms will be encouraged to receive NRT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self Reported Relapse Rate for Usual Care Arm | Measured using the modified Dillman method | 3 Months | 
| Self Reported Relapse Rate for Usual Care Arm | Measured using the modified Dillman method | 6 Months | 
| Self Reported Relapse Rate for Usual Care Arm | Measured using the modified Dillman method | 12 Months | 
| Self Reported Relapse Rate for relapse prevention intervention arm | Measured using the modified Dillman method | 3 Months | 
| Self Reported Relapse Rate for relapse prevention intervention arm | Measured using the modified Dillman method | 6 Months | 
| Self Reported Relapse Rate for relapse prevention intervention arm | Measured using the modified Dillman method | 12 Months |