Perioperative Smoking Cessation Interventions

Not Applicable

Terminated

• Conditions: Perioperative/Postoperative Complications; Smoking Cessation

• Registration Number: NCT03222908
• Lead Sponsor: Duke University

Brief Summary

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 Timeline

• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-19
• Study Start: 2017-08-15
• Primary Completion: 2018-06-20
• Study Completion: 2018-07-30
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-21
• Last Update Posted: 2018-12-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• active tobacco use
• preoperative appointment for an operation within 6 weeks

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Exclusion Criteria

• active enrollment in tobacco cessation program

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Smoking Cessation	day of first postoperative appointment	Smoking Cessation on first postoperative follow up appointment: quantitative point of care urine cotinine test

Secondary Outcome Measures

Name	Time	Method
Postoperative Complications	30 days postoperatively	National Surgical Quality Improvement Project postoperative complications: based on patient chart review

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States