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Perioperative Smoking Cessation Interventions

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ClinicalTrials.gov Identifier: NCT03222908
Recruitment Status : Terminated (Slow enrollment and lack of interest)
First Posted : July 19, 2017
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Perioperative/Postoperative Complications Behavioral: Intervention1: Contract Agreement Behavioral: Intervention2: Implementation Intentions Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized control
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Surgical Outcomes in Patients Undergoing Pre-commitment and Social Contracting for Smoking Cessation
Actual Study Start Date : August 15, 2017
Actual Primary Completion Date : June 20, 2018
Actual Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control: Prescriptive Advice
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
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
Smoking Cessation Contract

Experimental: Intervention2: Implementation Intentions
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 with worksheet for implementation intentions




Primary Outcome Measures :
  1. Smoking Cessation [ Time Frame: day of surgery ]
    Smoking Cessation on Day of Surgery: quantitative point of care urine cotinine test

  2. Smoking Cessation [ Time Frame: day of first postoperative appointment ]
    Smoking Cessation on first postoperative follow up appointment: quantitative point of care urine cotinine test


Secondary Outcome Measures :
  1. Postoperative Complications [ Time Frame: 30 days postoperatively ]
    National Surgical Quality Improvement Project postoperative complications: based on patient chart review



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • active enrollment in tobacco cessation program

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222908


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Christopher R Mantyh, MD DUKE DEPARTMENT OF SURGERY

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03222908     History of Changes
Other Study ID Numbers: Pro00076125
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to share data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Behavior
Perioperative/Postoperative Complications
contract agreement
implementation intentions
precommitment
smoking cessation
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes