Decision Aid for Cigarette Smokers Undergoing Surgery
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ClinicalTrials.gov Identifier: NCT01575119 |
Recruitment Status :
Completed
First Posted : April 11, 2012
Last Update Posted : December 17, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tobacco Abuse | Behavioral: Decision Aid Behavioral: Control intervention Behavioral: Control | Phase 3 |
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 |
Actual Primary Completion Date : | January 2014 |
Actual Study Completion Date : | January 2014 |
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
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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 |
- 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
- 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

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

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
United States, Minnesota | |
Mayo Clinic in Rochester | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | David Warner, MD | Mayo Clinic |
Responsible Party: | David Warner, Associate Director of Clinical and Translational Research, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT01575119 |
Other Study ID Numbers: |
11-009150 |
First Posted: | April 11, 2012 Key Record Dates |
Last Update Posted: | December 17, 2014 |
Last Verified: | December 2014 |
Cigarette smoker Elective surgery |
Tobacco Use Disorder Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |