Decision Aid for Cigarette Smokers Undergoing Surgery

December 16, 2014 updated by: David Warner, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed immediately after the time of the preoperative conversation in the preoperative clinic

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately after the preoperative evaluation in the preoperative clinic

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

April 5, 2012

First Submitted That Met QC Criteria

April 9, 2012

First Posted (Estimate)

April 11, 2012

Study Record Updates

Last Update Posted (Estimate)

December 17, 2014

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-009150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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