Decision Aid for Cigarette Smokers Undergoing Surgery

Tobacco Abuse Clinical Trial

Official title:

Decision Aid Development for Cigarette Smokers Undergoing Surgery: Specific Aim 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575119
• Other study ID #: 11-009150
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2012
• Last updated: December 16, 2014
• Start date: May 2012
• Est. completion date: January 2014

Study information

• Verified date: December 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Tobacco Abuse
• Tobacco Use Disorder

Intervention

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
• Control intervention
Standard of care information, including distributing patent education brochure, to provide information regarding perioperative smoking
• 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
• Control
Standard of care information, including distributing patient education brochure, to provide information regarding perioperative smoking

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measures of decisional quality	The Decisional Conflict Scale and the OPTION Scale will be utilized	Assessed immediately after the time of the preoperative conversation in the preoperative clinic	No
Secondary	Measures of intent and self-efficacy	Intent to quit smoking, and self-efficacy for quitting	Immediately after the preoperative evaluation in the preoperative clinic	No