An interventional study of Comprehensive Relapse Prevention Intervention and Standard Treatment Counseling in Smoking and Smoking Cessation, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-11-12.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
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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This study's enrollment of 21 is below the median of 50 across 3,373 interventional studies indexed under Recurrence.
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Patient Participants
Caregiver participants:
Exclusion Criteria:
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 · Drug: Nicotine Replacement Therapy (NRT)
Patients will receive current usual care.
Behavioral: Standard Treatment Counseling · Drug: Nicotine Replacement Therapy (NRT)
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
Participants will receive two 10 minute counseling calls from the staff of the preoperative counseling program during the first month after the hospital discharge
Patients in both arms will be encouraged to receive NRT
Self Reported Relapse Rate for Usual Care Arm
Measured using the modified Dillman method
Time frame: 3 Months
Self Reported Relapse Rate for Usual Care Arm
Measured using the modified Dillman method
Time frame: 6 Months
Self Reported Relapse Rate for Usual Care Arm
Measured using the modified Dillman method
Time frame: 12 Months
Self Reported Relapse Rate for relapse prevention intervention arm
Measured using the modified Dillman method
Time frame: 3 Months
Self Reported Relapse Rate for relapse prevention intervention arm
Measured using the modified Dillman method
Time frame: 6 Months
Self Reported Relapse Rate for relapse prevention intervention arm
Measured using the modified Dillman method
Time frame: 12 Months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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NYU Langone Health