An interventional study of Intervention1: Contract Agreement and Intervention2: Implementation Intentions in Smoking Cessation and Perioperative/Postoperative Complications, sponsored by Duke University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-26.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
To assess impact of behavioral economic principles of precommitment, implementation intentions, and social contracting on smoking cessation for patients undergoing surgery.
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.
1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.
This study's enrollment of 19 is below the median of 119 across 689 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
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
Smoking Cessation Contract with worksheet for implementation intentions
Smoking Cessation
Smoking Cessation on Day of Surgery: quantitative point of care urine cotinine test
Time frame: day of surgery
Smoking Cessation
Smoking Cessation on first postoperative follow up appointment: quantitative point of care urine cotinine test
Time frame: day of first postoperative appointment
Postoperative Complications
National Surgical Quality Improvement Project postoperative complications: based on patient chart review
Time frame: 30 days postoperatively
Plan to share: No — no plan to share data
No publications or documents are linked to this record.
This study is terminated, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Duke University