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Preventing Smoking Relapse After Total Joint Replacement Surgery

Primary Purpose

Smoking, Smoking Cessation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Relapse Prevention Intervention
Standard Treatment Counseling
Nicotine Replacement Therapy (NRT)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Standard treatment

Arm Description

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

Patients will receive current usual care.

Outcomes

Primary Outcome Measures

Self Reported Relapse Rate for Usual Care Arm
Measured using the modified Dillman method
Self Reported Relapse Rate for Usual Care Arm
Measured using the modified Dillman method
Self Reported Relapse Rate for Usual Care Arm
Measured using the modified Dillman method
Self Reported Relapse Rate for relapse prevention intervention arm
Measured using the modified Dillman method
Self Reported Relapse Rate for relapse prevention intervention arm
Measured using the modified Dillman method
Self Reported Relapse Rate for relapse prevention intervention arm
Measured using the modified Dillman method

Secondary Outcome Measures

Full Information

First Posted
August 27, 2018
Last Updated
November 10, 2021
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03673228
Brief Title
Preventing Smoking Relapse After Total Joint Replacement Surgery
Official Title
Preventing Smoking Relapse After Total Joint Replacement Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
January 28, 2021 (Actual)
Study Completion Date
January 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Smoking Cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
Patients will receive current usual care.
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive Relapse Prevention Intervention
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Standard Treatment Counseling
Intervention Description
Participants will receive two 10 minute counseling calls from the staff of the preoperative counseling program during the first month after the hospital discharge
Intervention Type
Drug
Intervention Name(s)
Nicotine Replacement Therapy (NRT)
Intervention Description
Patients in both arms will be encouraged to receive NRT
Primary Outcome Measure Information:
Title
Self Reported Relapse Rate for Usual Care Arm
Description
Measured using the modified Dillman method
Time Frame
3 Months
Title
Self Reported Relapse Rate for Usual Care Arm
Description
Measured using the modified Dillman method
Time Frame
6 Months
Title
Self Reported Relapse Rate for Usual Care Arm
Description
Measured using the modified Dillman method
Time Frame
12 Months
Title
Self Reported Relapse Rate for relapse prevention intervention arm
Description
Measured using the modified Dillman method
Time Frame
3 Months
Title
Self Reported Relapse Rate for relapse prevention intervention arm
Description
Measured using the modified Dillman method
Time Frame
6 Months
Title
Self Reported Relapse Rate for relapse prevention intervention arm
Description
Measured using the modified Dillman method
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Sherman, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Preventing Smoking Relapse After Total Joint Replacement Surgery

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