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Decision Aid for Cigarette Smokers Undergoing Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01575119
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : December 17, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Tobacco Abuse Behavioral: Decision Aid Behavioral: Control intervention Behavioral: Control Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Decision Aid Development for Cigarette Smokers Undergoing Surgery: Specific Aim 2
Study Start Date : May 2012
Primary Completion Date : January 2014
Study Completion Date : January 2014
Arms and Interventions

Arm Intervention/treatment
Experimental: In-patient surgery
Decision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery
Behavioral: Decision Aid
Decision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery
Active Comparator: In-patient
Standard of care information, including distributing patient education brochure, to provide information regarding perioperative smoking
Behavioral: Control intervention
Standard of care information, including distributing patent education brochure, to provide information regarding perioperative smoking
Experimental: Out-patient surgery
Decision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery
Behavioral: Decision Aid
Decision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery
Active Comparator: Out-patient
Standard of care information, including distributing a patient education brochure, to provide information regarding perioperative smoking
Behavioral: Control
Standard of care information, including distributing patient education brochure, to provide information regarding perioperative smoking


Outcome Measures

Primary Outcome Measures :
  1. Measures of decisional quality [ Time Frame: Assessed immediately after the time of the preoperative conversation in the preoperative clinic ]
    The Decisional Conflict Scale and the OPTION Scale will be utilized


Secondary Outcome Measures :
  1. Measures of intent and self-efficacy [ Time Frame: Immediately after the preoperative evaluation in the preoperative clinic ]
    Intent to quit smoking, and self-efficacy for quitting


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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): NCT01575119


Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: David Warner, MD Mayo Clinic
More Information

Responsible Party: David Warner, Associate Director of Clinical and Translational Research, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01575119     History of Changes
Other Study ID Numbers: 11-009150
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: December 2014

Keywords provided by David Warner, Mayo Clinic:
Cigarette smoker
Elective surgery

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders