SmokingNCT03673228
Preventing Smoking Relapse After Total Joint Replacement Surgery
A study testing Comprehensive Relapse Prevention Intervention, Standard Treatment Counseling and Nicotine Replacement Therapy (NRT) in people with Smoking and Smoking Cessation, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Smoking, Smoking Cessation
- What is being tested?
- Comprehensive Relapse Prevention Intervention, Standard Treatment Counseling and Nicotine Replacement Therapy (NRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 28 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Caregiver participants:
- Age ≥ 18 years
- Be a caregiver of the patient participant
- Provide informed consent in English
Who cannot join
- Patients will be excluded if they used smokeless tobacco or an electronic cigarette in the last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
Read the 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.
- Conditions
- Smoking, Smoking Cessation
- Being tested
- Comprehensive Relapse Prevention Intervention, Standard Treatment Counseling, Nicotine Replacement Therapy (NRT)
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Relapse Prevention InterventionBehavioural
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 CounselingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Comprehensive Relapse Prevention Intervention; Drug: Nicotine Replacement Therapy (NRT) |
| Standard treatment | Active comparator | Patients will receive current usual care. Receives: Behavioral: Standard Treatment Counseling; Drug: Nicotine Replacement Therapy (NRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Reported Relapse Rate for Usual Care Arm
Measured using the modified Dillman method
Measured: 3 Months
Self Reported Relapse Rate for Usual Care Arm
Measured using the modified Dillman method
Measured: 6 Months
Self Reported Relapse Rate for Usual Care Arm
Measured using the modified Dillman method
Measured: 12 Months
Self Reported Relapse Rate for relapse prevention intervention arm
Measured using the modified Dillman method
Measured: 3 Months
Self Reported Relapse Rate for relapse prevention intervention arm
Measured using the modified Dillman method
Measured: 6 Months
Self Reported Relapse Rate for relapse prevention intervention arm
Measured using the modified Dillman method
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start15 Jan 2019
- Primary completion28 Jan 2021
- Study completion28 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Sherman, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673228
- Sponsor's protocol ID
- 18-00723
- Status last verified
- Nov 2021
- First submitted
- 27 Aug 2018
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Smoking Relapse After Total Joint Replacement Surgery
- ClinicalTrials.gov ID
- NCT03673228
- Acronym / sponsor ID
- 18-00723
- Conditions
- Smoking, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 28 Jan 2021 (actual)
- Study completion
- 28 Jan 2021 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Comprehensive Relapse Prevention Intervention, Drug: Nicotine Replacement Therapy (NRT)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 |
| Standard treatment | Active comparator | Behavioral: Standard Treatment Counseling, Drug: Nicotine Replacement Therapy (NRT)Patients will receive current usual care. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (1 listed)
- Patients will be excluded if they used smokeless tobacco or an electronic cigarette in the last 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Relapse Prevention InterventionThis 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 | Behavioural | Intervention Group |
| Standard Treatment CounselingParticipants will receive two 10 minute counseling calls from the staff of the preoperative counseling program during the first month after the hospital discharge | Behavioural | Standard treatment |
| Nicotine Replacement Therapy (NRT)Patients in both arms will be encouraged to receive NRT | Drug | Intervention Group, Standard treatment |
Primary outcome
Self Reported Relapse Rate for Usual Care Arm
Time frame: 3 Months
Measured using the modified Dillman method
Self Reported Relapse Rate for Usual Care Arm
Time frame: 6 Months
Measured using the modified Dillman method
Self Reported Relapse Rate for Usual Care Arm
Time frame: 12 Months
Measured using the modified Dillman method
Self Reported Relapse Rate for relapse prevention intervention arm
Time frame: 3 Months
Measured using the modified Dillman method
Self Reported Relapse Rate for relapse prevention intervention arm
Time frame: 6 Months
Measured using the modified Dillman method
Self Reported Relapse Rate for relapse prevention intervention arm
Time frame: 12 Months
Measured using the modified Dillman method
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Sherman, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Relapse Prevention Intervention, Standard Treatment Counseling and Nicotine Replacement Therapy (NRT) in people with Smoking and Smoking Cessation, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self Reported Relapse Rate for Usual Care Arm (time frame: 3 Months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2021.