Smoking CessationNCT03222908
Perioperative Smoking Cessation Interventions
A study testing Intervention1: Contract Agreement and Intervention2: Implementation Intentions in people with Smoking Cessation and Perioperative/Postoperative Complications, run by Duke University at 1 site in United States.
Trial summary
To assess impact of behavioral economic principles of precommitment, implementation intentions, and social contracting on smoking cessation for patients undergoing surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Perioperative/Postoperative Complications
- What is being tested?
- Intervention1: Contract Agreement and Intervention2: Implementation Intentions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2017to 30 Jul 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- active tobacco use
- preoperative appointment for an operation within 6 weeks
Who cannot join
- active enrollment in tobacco cessation program
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Evaluation of Surgical Outcomes in Patients Undergoing Pre-commitment and Social Contracting for Smoking Cessation
To assess impact of behavioral economic principles of precommitment, implementation intentions, and social contracting on smoking cessation for patients undergoing surgery.
Read the detailed description
Purpose \& Objective: Behavioral interventions in surgical patients are an opportunity to improve outcomes through decreased complications, with measurable economic impact. Smoking cessation is one of the most desirable long-term health behaviors for adults with potential substantial impact on postoperative complications
Study Activity \& Population Group: The investigators propose a precommitment contractual agreement implementing behavioral economic principles at the preoperative appointment for active tobacco users undergoing an operation and assessing for ability to quit smoking with testing on the day of surgery, and the durability of cessation over the postoperative course as measured with urine nicotine testing at follow up appointments. The population of interest is adults who currently smoke tobacco or vaporized nicotine who are scheduled to undergo a major operation. The control group is standard of care; prescriptive advice to quit smoking. The intervention is contract agreement for preoperative cessation.
Data Analysis \& Risk Issues: Following informed consent patients will be randomized to control or intervention groups, baseline urine nicotine tests will be performed in clinic. Urine nicotine testing will be performed on the day of enrollment, the day of their operation, and at their one-month follow up appointments. Thirty-day outcomes will be evaluated by retrospective chart review.
- Being tested
- Intervention1: Contract Agreement, Intervention2: Implementation Intentions
- Keywords
- Behavior, Perioperative/Postoperative Complications, contract agreement, implementation intentions, precommitment, smoking cessation
- Medical subject headings
- Smoking Cessation, Postoperative Complications, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention1: Contract AgreementBehavioural
Smoking Cessation Contract
Intervention2: Implementation IntentionsBehavioural
Smoking Cessation Contract with worksheet for implementation intentions
| Study group | Role | What they receive |
|---|---|---|
| Control: Prescriptive Advice | No intervention | Amenable patients will be enrolled into the study, their intervention will be current standard of care smoking cessation counseling by their surgeon, they will undergo 3 urine tests and a chart review for outcomes. |
| Intervention1: Contract Agreement | Experimental | Amenable patients will be enrolled into the study, their intervention will be a smoking cessation contract with their surgeon, they will undergo 3 urine tests and a chart review for outcomes. Receives: Behavioral: Intervention1: Contract Agreement |
| Intervention2: Implementation Intentions | Experimental | Amenable patients will be enrolled into the study, their intervention will be a worksheet to fill out with their smoking cessation implementation intentions that will be signed by patient and surgeon, they will undergo 3 urine tests and a chart review for outcomes. Receives: Behavioral: Intervention2: Implementation Intentions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation
Smoking Cessation on Day of Surgery: quantitative point of care urine cotinine test
Measured: day of surgery
Smoking Cessation
Smoking Cessation on first postoperative follow up appointment: quantitative point of care urine cotinine test
Measured: day of first postoperative appointment
Secondary outcomes (1)
Postoperative Complications
National Surgical Quality Improvement Project postoperative complications: based on patient chart review
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start15 Aug 2017
- Primary completion20 Jun 2018
- Study completion30 Jul 2018
Why it stopped: Slow enrollment and lack of interest
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Model description
- randomized control
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher R Mantyh, MD, Principal investigator, DUKE DEPARTMENT OF SURGERY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222908
- Sponsor's protocol ID
- Pro00076125
- Status last verified
- Dec 2018
- First submitted
- 18 Jul 2017
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surgical Outcomes in Patients Undergoing Pre-commitment and Social Contracting for Smoking Cessation
- ClinicalTrials.gov ID
- NCT03222908
- Acronym / sponsor ID
- Pro00076125
- Keywords
- Behavior, Perioperative/Postoperative Complications, contract agreement, implementation intentions, precommitment, smoking cessation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment and lack of interest
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 19 Jul 2017 (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.
To assess impact of behavioral economic principles of precommitment, implementation intentions, and social contracting on smoking cessation for patients undergoing surgery.
Detailed description
Purpose \& Objective: Behavioral interventions in surgical patients are an opportunity to improve outcomes through decreased complications, with measurable economic impact. Smoking cessation is one of the most desirable long-term health behaviors for adults with potential substantial impact on postoperative complications
Study Activity \& Population Group: The investigators propose a precommitment contractual agreement implementing behavioral economic principles at the preoperative appointment for active tobacco users undergoing an operation and assessing for ability to quit smoking with testing on the day of surgery, and the durability of cessation over the postoperative course as measured with urine nicotine testing at follow up appointments. The population of interest is adults who currently smoke tobacco or vaporized nicotine who are scheduled to undergo a major operation. The control group is standard of care; prescriptive advice to quit smoking. The intervention is contract agreement for preoperative cessation.
Data Analysis \& Risk Issues: Following informed consent patients will be randomized to control or intervention groups, baseline urine nicotine tests will be performed in clinic. Urine nicotine testing will be performed on the day of enrollment, the day of their operation, and at their one-month follow up appointments. Thirty-day outcomes will be evaluated by retrospective chart review.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized control
| Arm | Type | Receives |
|---|---|---|
| Control: Prescriptive Advice | No intervention | –Amenable patients will be enrolled into the study, their intervention will be current standard of care smoking cessation counseling by their surgeon, they will undergo 3 urine tests and a chart review for outcomes. |
| Intervention1: Contract Agreement | Experimental | Behavioral: Intervention1: Contract AgreementAmenable patients will be enrolled into the study, their intervention will be a smoking cessation contract with their surgeon, they will undergo 3 urine tests and a chart review for outcomes. |
| Intervention2: Implementation Intentions | Experimental | Behavioral: Intervention2: Implementation IntentionsAmenable patients will be enrolled into the study, their intervention will be a worksheet to fill out with their smoking cessation implementation intentions that will be signed by patient and surgeon, they will undergo 3 urine tests and a chart review for outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- active tobacco use
- preoperative appointment for an operation within 6 weeks
Key exclusion criteria (1 listed)
- active enrollment in tobacco cessation program
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 |
|---|---|---|
| Intervention1: Contract AgreementSmoking Cessation Contract | Behavioural | Intervention1: Contract Agreement |
| Intervention2: Implementation IntentionsSmoking Cessation Contract with worksheet for implementation intentions | Behavioural | Intervention2: Implementation Intentions |
Primary outcome
Smoking Cessation
Time frame: day of surgery
Smoking Cessation on Day of Surgery: quantitative point of care urine cotinine test
Smoking Cessation
Time frame: day of first postoperative appointment
Smoking Cessation on first postoperative follow up appointment: quantitative point of care urine cotinine test
1 secondary outcome
Postoperative Complications
Time frame: 30 days postoperatively
Results and safety
The study was stopped early (reason given: Slow enrollment and lack of interest). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Individual participant dataSharing planned: No. no plan to share data
Related trials for Smoking Cessation
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation
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.
Christopher R Mantyh, MD principal investigator
DUKE DEPARTMENT OF SURGERY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention1: Contract Agreement and Intervention2: Implementation Intentions in people with Smoking Cessation and Perioperative/Postoperative Complications, run by Duke University 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 2 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: stopped early, as of the sponsor's last update on 26 Dec 2018. 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 was stopped early (reason given: Slow enrollment and lack of interest). Results are not available in the source record.
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?
Smoking Cessation (time frame: day of surgery). The study lists 2 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 26 Dec 2018.