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OpenTrials
Completed

NCT Number: NCT03673228

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.

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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Comprehensive Relapse Prevention Intervention

Behavioral

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

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

Nicotine replacement therapy (NRT)

Drug

Patients in both arms will be encouraged to receive NRT

Primary outcomes

  1. Self Reported Relapse Rate for Usual Care Arm

    Time frame: 3 Months

    Measured using the modified Dillman method

  2. Self Reported Relapse Rate for Usual Care Arm

    Time frame: 6 Months

    Measured using the modified Dillman method

  3. Self Reported Relapse Rate for Usual Care Arm

    Time frame: 12 Months

    Measured using the modified Dillman method

  4. Self Reported Relapse Rate for relapse prevention intervention arm

    Time frame: 3 Months

    Measured using the modified Dillman method

  5. Self Reported Relapse Rate for relapse prevention intervention arm

    Time frame: 6 Months

    Measured using the modified Dillman method

  6. Self Reported Relapse Rate for relapse prevention intervention arm

    Time frame: 12 Months

    Measured using the modified Dillman method

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 17, 2018
Registry last updated
Nov 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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