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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Participants randomized to the Intervention Arm will receive counseling that includes:
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| Standard treatment | Active Comparator | Patients will receive current usual care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Relapse Prevention Intervention | Behavioral | This intervention consists of 4 components:
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| 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 |
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Inclusion Criteria:
Patient Participants
Caregiver participants:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Sherman, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Standard Treatment Counseling | Behavioral | Participants will receive two 10 minute counseling calls from the staff of the preoperative counseling program during the first month after the hospital discharge |
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| Nicotine Replacement Therapy (NRT) | Drug | Patients in both arms will be encouraged to receive NRT |
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