Preventing Smoking Relapse After Total Joint Replacement Surgery

NCT03673228 | Completed

• 1 other identifier: 18-00723
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Smoking Cessation

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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)

Standard treatment

ACTIVE COMPARATOR

Patients will receive current usual care.

Behavioral: Standard Treatment Counseling; Drug: Nicotine Replacement Therapy (NRT)

Interventions

Comprehensive Relapse Prevention Intervention BEHAVIORAL

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

Intervention Group

Standard Treatment Counseling BEHAVIORAL

Participants will receive two 10 minute counseling calls from the staff of the preoperative counseling program during the first month after the hospital discharge

Standard treatment

Nicotine Replacement Therapy (NRT) DRUG

Patients in both arms will be encouraged to receive NRT

Intervention Group; Standard treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients will be excluded if they used smokeless tobacco or an electronic cigarette in the last 30 days.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Scott Sherman, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: September 17, 2018
• Study Start: January 15, 2019
• Primary Completion: January 28, 2021
• Study Completion: January 28, 2021
• Last Updated: November 12, 2021

Record last verified: 2021-11

Locations

US (1)