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Slow enrollment and lack of interest
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention1: Contract Agreement | Behavioral | Smoking Cessation Contract |
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| Measure | Description | Time Frame |
|---|---|---|
| Smoking Cessation | Smoking Cessation on Day of Surgery: quantitative point of care urine cotinine test | day of surgery |
| Smoking Cessation | Smoking Cessation on first postoperative follow up appointment: quantitative point of care urine cotinine test | day of first postoperative appointment |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Complications | National Surgical Quality Improvement Project postoperative complications: based on patient chart review | 30 days postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher R Mantyh, MD | DUKE DEPARTMENT OF SURGERY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
no plan to share data
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D011183 | Postoperative Complications |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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randomized control
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| Intervention2: Implementation Intentions | Behavioral | Smoking Cessation Contract with worksheet for implementation intentions |
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