Preventing Smoking Relapse After Total Joint Replacement Surgery

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT03673228

Collaborator

(none)

Enrollment

Location

Arms

24.4

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Smoking Cessation	Behavioral: Comprehensive Relapse Prevention Intervention Behavioral: Standard Treatment Counseling Drug: Nicotine Replacement Therapy (NRT)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Preventing Smoking Relapse After Total Joint Replacement Surgery

Actual Study Start Date :

Jan 15, 2019

Actual Primary Completion Date :

Jan 28, 2021

Actual Study Completion Date :

Jan 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group 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 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 Drug: Nicotine Replacement Therapy (NRT) Patients in both arms will be encouraged to receive NRT
Active Comparator: Standard treatment Patients will receive current usual care.	Behavioral: 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

Arm

Intervention/Treatment

Experimental: Intervention Group

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

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

Drug: Nicotine Replacement Therapy (NRT)

Patients in both arms will be encouraged to receive NRT

Active Comparator: Standard treatment

Patients will receive current usual care.

Behavioral: 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

Outcome Measures

Primary Outcome Measures

Self Reported Relapse Rate for Usual Care Arm [3 Months]
Measured using the modified Dillman method
Self Reported Relapse Rate for Usual Care Arm [6 Months]
Measured using the modified Dillman method
Self Reported Relapse Rate for Usual Care Arm [12 Months]
Measured using the modified Dillman method
Self Reported Relapse Rate for relapse prevention intervention arm [3 Months]
Measured using the modified Dillman method
Self Reported Relapse Rate for relapse prevention intervention arm [6 Months]
Measured using the modified Dillman method
Self Reported Relapse Rate for relapse prevention intervention arm [12 Months]
Measured using the modified Dillman method

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Scott Sherman, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT03673228

Other Study ID Numbers:

18-00723

First Posted:

Sep 17, 2018

Last Update Posted:

Nov 12, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Recurrence

Nicotine

Study Results

No Results Posted as of Nov 12, 2021