Perioperative Smoking Cessation Interventions

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03222908
• Other study ID #: Pro00076125
• Status: Terminated
• Phase: N/A
• Start date: August 15, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: December 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess impact of behavioral economic principles of precommitment, implementation intentions, and social contracting on smoking cessation for patients undergoing surgery.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: July 30, 2018
• Est. primary completion date: June 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• active tobacco use

• preoperative appointment for an operation within 6 weeks

Exclusion Criteria:

• active enrollment in tobacco cessation program

Related Conditions & MeSH terms

• Perioperative/Postoperative Complications
• Postoperative Complications
• Smoking Cessation

Intervention

Behavioral:
• Intervention1: Contract Agreement
Smoking Cessation Contract
• Intervention2: Implementation Intentions
Smoking Cessation Contract with worksheet for implementation intentions

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Cessation	Smoking Cessation on Day of Surgery: quantitative point of care urine cotinine test	day of surgery
Primary	Smoking Cessation	Smoking Cessation on first postoperative follow up appointment: quantitative point of care urine cotinine test	day of first postoperative appointment
Secondary	Postoperative Complications	National Surgical Quality Improvement Project postoperative complications: based on patient chart review	30 days postoperatively