Preventing Smoking Relapse After Total Joint Replacement Surgery

Smoking Cessation Clinical Trial

Official title:

Preventing Smoking Relapse After Total Joint Replacement Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03673228
• Other study ID #: 18-00723
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: January 28, 2021

Study information

• Verified date: November 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 28, 2021
• Est. primary completion date: January 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Recurrence
• Smoking
• Smoking Cessation

Intervention

Behavioral:
• Comprehensive Relapse Prevention Intervention
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
• Standard 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

Drug:
• Nicotine Replacement Therapy (NRT)
Patients in both arms will be encouraged to receive NRT

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self Reported Relapse Rate for Usual Care Arm	Measured using the modified Dillman method	3 Months
Primary	Self Reported Relapse Rate for Usual Care Arm	Measured using the modified Dillman method	6 Months
Primary	Self Reported Relapse Rate for Usual Care Arm	Measured using the modified Dillman method	12 Months
Primary	Self Reported Relapse Rate for relapse prevention intervention arm	Measured using the modified Dillman method	3 Months
Primary	Self Reported Relapse Rate for relapse prevention intervention arm	Measured using the modified Dillman method	6 Months
Primary	Self Reported Relapse Rate for relapse prevention intervention arm	Measured using the modified Dillman method	12 Months