NCT01575119

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 11, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

December 17, 2014

Status Verified

December 1, 2014

Enrollment Period

1.7 years

First QC Date

April 5, 2012

Last Update Submit

December 16, 2014

Conditions

Tobacco Abuse

Keywords

Cigarette smokerElective surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Measures of intent and self-efficacy

    Immediately after the preoperative evaluation in the preoperative clinic

Study Arms (4)

In-patient surgery

EXPERIMENTAL

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

In-patient

ACTIVE COMPARATOR

Standard of care information, including distributing patient education brochure, to provide information regarding perioperative smoking

Behavioral: Control intervention

Out-patient surgery

EXPERIMENTAL

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

Out-patient

ACTIVE COMPARATOR

Standard of care information, including distributing a patient education brochure, to provide information regarding perioperative smoking

Behavioral: Control

Interventions

Decision AidBEHAVIORAL

Decision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery

In-patient surgery
Control interventionBEHAVIORAL

Standard of care information, including distributing patent education brochure, to provide information regarding perioperative smoking

In-patient
ControlBEHAVIORAL

Standard of care information, including distributing patient education brochure, to provide information regarding perioperative smoking

Out-patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unavailable for telephone follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • David Warner, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director of Clinical and Translational Research

Study Record Dates

First Submitted

April 5, 2012

First Posted

April 11, 2012

Study Start

May 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

December 17, 2014

Record last verified: 2014-12

Locations

US(1)