Back to resultsDecision Aid for Cigarette Smokers Undergoing Surgery
Primary Purpose
Tobacco Abuse
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Decision Aid
Control intervention
Decision Aid
Control
Sponsored by
About this trial
This is an interventional supportive care trial for Tobacco Abuse focused on measuring Cigarette smoker, Elective surgery
Eligibility Criteria
Inclusion Criteria:
- Current cigarette smoker
- Scheduled to undergo elective surgery at Mayo Clinic Rochester
- Age 18 years or older
- Able to fully participate in all study aspects
Exclusion Criteria:
- Unavailable for telephone follow-up
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
In-patient surgery
In-patient
Out-patient surgery
Out-patient
Arm Description
Decision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery
Standard of care information, including distributing patient education brochure, to provide information regarding perioperative smoking
Decision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery
Standard of care information, including distributing a patient education brochure, to provide information regarding perioperative smoking
Outcomes
Primary Outcome Measures
Measures of decisional quality
The Decisional Conflict Scale and the OPTION Scale will be utilized
Secondary Outcome Measures
Measures of intent and self-efficacy
Intent to quit smoking, and self-efficacy for quitting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01575119
Brief Title
Decision Aid for Cigarette Smokers Undergoing Surgery
Official Title
Decision Aid Development for Cigarette Smokers Undergoing Surgery: Specific Aim 2
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Smokers have three choices when faced with surgery: keep smoking, quit for a short time around surgery or quit for good. In the first specific aim, a decision aid was designed to help facilitate the discussion of these choices between smokers and healthcare providers. This second aim will test whether this decision aid improves the decisional quality compared with standard methods used to discuss perioperative smoking.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Abuse
Keywords
Cigarette smoker, Elective surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
In-patient surgery
Arm Type
Experimental
Arm Description
Decision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery
Arm Title
In-patient
Arm Type
Active Comparator
Arm Description
Standard of care information, including distributing patient education brochure, to provide information regarding perioperative smoking
Arm Title
Out-patient surgery
Arm Type
Experimental
Arm Description
Decision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery
Arm Title
Out-patient
Arm Type
Active Comparator
Arm Description
Standard of care information, including distributing a patient education brochure, to provide information regarding perioperative smoking
Intervention Type
Behavioral
Intervention Name(s)
Decision Aid
Intervention Description
Decision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery
Intervention Type
Behavioral
Intervention Name(s)
Control intervention
Intervention Description
Standard of care information, including distributing patent education brochure, to provide information regarding perioperative smoking
Intervention Type
Behavioral
Intervention Name(s)
Decision Aid
Intervention Description
Decision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Standard of care information, including distributing patient education brochure, to provide information regarding perioperative smoking
Primary Outcome Measure Information:
Title
Measures of decisional quality
Description
The Decisional Conflict Scale and the OPTION Scale will be utilized
Time Frame
Assessed immediately after the time of the preoperative conversation in the preoperative clinic
Secondary Outcome Measure Information:
Title
Measures of intent and self-efficacy
Description
Intent to quit smoking, and self-efficacy for quitting
Time Frame
Immediately after the preoperative evaluation in the preoperative clinic
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current cigarette smoker
Scheduled to undergo elective surgery at Mayo Clinic Rochester
Age 18 years or older
Able to fully participate in all study aspects
Exclusion Criteria:
Unavailable for telephone follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Warner, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Decision Aid for Cigarette Smokers Undergoing Surgery
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