Decision Aid for Cigarette Smokers Undergoing Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
David Warner, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01575119
First received: April 5, 2012
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Tobacco Abuse
Behavioral: Decision Aid
Behavioral: Control intervention
Behavioral: Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Decision Aid Development for Cigarette Smokers Undergoing Surgery: Specific Aim 2

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Measures of decisional quality [ Time Frame: Assessed immediately after the time of the preoperative conversation in the preoperative clinic ] [ Designated as safety issue: No ]
    The Decisional Conflict Scale and the OPTION Scale will be utilized


Secondary Outcome Measures:
  • Measures of intent and self-efficacy [ Time Frame: Immediately after the preoperative evaluation in the preoperative clinic ] [ Designated as safety issue: No ]
    Intent to quit smoking, and self-efficacy for quitting


Estimated Enrollment: 170
Study Start Date: May 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 5, 2012
Last Updated: August 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Cigarette smoker
Elective surgery

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

ClinicalTrials.gov processed this record on August 28, 2014