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Perioperative Smoking Cessation Interventions

Primary Purpose

Smoking Cessation, Perioperative/Postoperative Complications

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention1: Contract Agreement
Intervention2: Implementation Intentions
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation focused on measuring Behavior, Perioperative/Postoperative Complications, contract agreement, implementation intentions, precommitment, smoking cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • active enrollment in tobacco cessation program

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control: Prescriptive Advice

Intervention1: Contract Agreement

Intervention2: Implementation Intentions

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Smoking Cessation
Smoking Cessation on Day of Surgery: quantitative point of care urine cotinine test
Smoking Cessation
Smoking Cessation on first postoperative follow up appointment: quantitative point of care urine cotinine test

Secondary Outcome Measures

Postoperative Complications
National Surgical Quality Improvement Project postoperative complications: based on patient chart review

Full Information

First Posted
July 18, 2017
Last Updated
December 21, 2018
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03222908
Brief Title
Perioperative Smoking Cessation Interventions
Official Title
Evaluation of Surgical Outcomes in Patients Undergoing Pre-commitment and Social Contracting for Smoking Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment and lack of interest
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
June 20, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Perioperative/Postoperative Complications
Keywords
Behavior, Perioperative/Postoperative Complications, contract agreement, implementation intentions, precommitment, smoking cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control: Prescriptive Advice
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention1: Contract Agreement
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention2: Implementation Intentions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention1: Contract Agreement
Intervention Description
Smoking Cessation Contract
Intervention Type
Behavioral
Intervention Name(s)
Intervention2: Implementation Intentions
Intervention Description
Smoking Cessation Contract with worksheet for implementation intentions
Primary Outcome Measure Information:
Title
Smoking Cessation
Description
Smoking Cessation on Day of Surgery: quantitative point of care urine cotinine test
Time Frame
day of surgery
Title
Smoking Cessation
Description
Smoking Cessation on first postoperative follow up appointment: quantitative point of care urine cotinine test
Time Frame
day of first postoperative appointment
Secondary Outcome Measure Information:
Title
Postoperative Complications
Description
National Surgical Quality Improvement Project postoperative complications: based on patient chart review
Time Frame
30 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: active tobacco use preoperative appointment for an operation within 6 weeks Exclusion Criteria: active enrollment in tobacco cessation program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher R Mantyh, MD
Organizational Affiliation
DUKE DEPARTMENT OF SURGERY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no plan to share data

Learn more about this trial

Perioperative Smoking Cessation Interventions

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