Perioperative Smoking Cessation Interventions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Surgical Outcomes in Patients Undergoing Pre-commitment and Social Contracting for Smoking Cessation

Conditions
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Smoking Cessation, Perioperative/Postoperative Complications

Intervention / Treatment
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* Behavioral: Intervention1: Contract Agreement
* Behavioral: Intervention2: Implementation Intentions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: active tobacco use preoperative appointment for an operation within 6 weeks Exclusion Criteria: active enrollment in tobacco cessation program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control: Prescriptive Advice<br>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<br>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<br>* Smoking Cessation Contract<br>|
| Experimental: Intervention2: Implementation Intentions<br>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<br>* Smoking Cessation Contract with worksheet for implementation intentions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Complications | National Surgical Quality Improvement Project postoperative complications: based on patient chart review | 30 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavior, Perioperative/Postoperative Complications, contract agreement, implementation intentions, precommitment, smoking cessation