Preventing Smoking Relapse After Total Joint Replacement Surgery

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Drug: Nicotine Replacement Therapy (NRT); Patients in both arms will be encouraged to receive NRT; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self Reported Relapse Rate for Usual Care Arm	Measured using the modified Dillman method	3 Months
Self Reported Relapse Rate for Usual Care Arm	Measured using the modified Dillman method	6 Months
Self Reported Relapse Rate for Usual Care Arm	Measured using the modified Dillman method	12 Months
Self Reported Relapse Rate for relapse prevention intervention arm	Measured using the modified Dillman method	3 Months
Self Reported Relapse Rate for relapse prevention intervention arm	Measured using the modified Dillman method	6 Months
Self Reported Relapse Rate for relapse prevention intervention arm	Measured using the modified Dillman method	12 Months

Collaborators and Investigators

• Sponsor: NYU Langone Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2019
• Primary Completion (ACTUAL): January 28, 2021
• Study Completion (ACTUAL): January 28, 2021

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (ACTUAL): September 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 12, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 18-00723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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