Preventing Smoking Relapse After Total Joint Replacement Surgery

Not Applicable

Completed

• Conditions: Smoking; Smoking Cessation
• Interventions: Behavioral: Standard Treatment Counseling; Behavioral: Comprehensive Relapse Prevention Intervention; Drug: Nicotine Replacement Therapy (NRT)

• Registration Number: NCT03673228
• Lead Sponsor: NYU Langone Health

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 Timeline

• Study First Submitted: 2018-08-27
• Study First Submitted QC: 2018-09-14
• Study First Posted: 2018-09-17
• Study Start: 2019-01-15
• Primary Completion: 2021-01-28
• Study Completion: 2021-01-28
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-10
• Last Update Posted: 2021-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

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Exclusion Criteria

• Patients will be excluded if they used smokeless tobacco or an electronic cigarette in the last 30 days.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Nicotine Replacement Therapy (NRT)	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
Standard treatment	Nicotine Replacement Therapy (NRT)	Patients will receive current usual care.
Standard treatment	Standard Treatment Counseling	Patients will receive current usual care.
Intervention Group	Comprehensive Relapse Prevention Intervention	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

Primary Outcome Measures

Name	Time	Method
Self Reported Relapse Rate for relapse prevention intervention arm	12 Months	Measured using the modified Dillman method
Self Reported Relapse Rate for Usual Care Arm	12 Months	Measured using the modified Dillman method

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States