Perioperative Smoking Cessation Interventions
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|ClinicalTrials.gov Identifier: NCT03222908|
Recruitment Status : Terminated (Slow enrollment and lack of interest)
First Posted : July 19, 2017
Last Update Posted : December 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation Perioperative/Postoperative Complications||Behavioral: Intervention1: Contract Agreement Behavioral: Intervention2: Implementation Intentions||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized control|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Surgical Outcomes in Patients Undergoing Pre-commitment and Social Contracting for Smoking Cessation|
|Actual Study Start Date :||August 15, 2017|
|Actual Primary Completion Date :||June 20, 2018|
|Actual Study Completion Date :||July 30, 2018|
No Intervention: Control: Prescriptive Advice
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.
Experimental: Intervention1: Contract Agreement
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.
Behavioral: Intervention1: Contract Agreement
Smoking Cessation Contract
Experimental: Intervention2: Implementation Intentions
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.
Behavioral: Intervention2: Implementation Intentions
Smoking Cessation Contract with worksheet for implementation intentions
- 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
- Postoperative Complications [ Time Frame: 30 days postoperatively ]National Surgical Quality Improvement Project postoperative complications: based on patient chart review
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222908
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Christopher R Mantyh, MD||DUKE DEPARTMENT OF SURGERY|