Quitline Use in Surgical Patients

February 2, 2012 updated by: David Warner, Mayo Clinic

Increasing QUITPLAN Helpline Utilization in Surgical Patients

Elective surgery represents a teachable moment to deliver tobacco interventions. The overall goal of this proposal is to increase the utilization of the QUITPLANSM Helpline by surgical patients who smoke. Two specific aims will be pursued using a multidisciplinary research team. In the first aim, we will develop a practice-based intervention to promote QUITPLANSM Helpline utilization by surgical patients (Specific Aim 1A) using a combination of key informant interviews (approximately 30 subjects), and focus groups (approximately 25 subjects) then develop methods to educate providers in its implementation (Specific Aim 1B) and test their effectiveness in approximately 20 providers. In the second aim, we will perform a randomized clinical trial of this intervention in 300 patients scheduled for elective surgery, with the primary outcome being utilization of the QUITPLANSM Helpline (Specific Aim 2). Subjects will be randomized to receive either the intervention developed in Specific Aim 1, or a brief control intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients ≥ 18 yrs. scheduled for elective surgery at Mayo Clinic Rochester.
  • Current smoking before the scheduling of surgery, defined as > 100 cigarettes lifetime consumption and self-reports of smoking either every day or some days. Patients who are in the midst of a quit attempt initiated since learning about surgery are eligible.

Exclusion Criteria:

  • Patient is not available 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Brief assistance with smoking abstinence
Behavioral: Standard brief advice
Brief general assistance with smoking cessation
Experimental: 2
Brief intervention to promote quitline utilization
Behavioral: Quitline intervention
Brief intervention designed specifically to encourage quitline utilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Completion of one quitline counseling session
Time Frame: Three months postoepratively
Three months postoepratively

Secondary Outcome Measures

Outcome Measure
Time Frame
Smoking behavior at six months postoperatively
Time Frame: six months postoperatively
six months postoperatively

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: David O. Warner, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

April 4, 2008

First Submitted That Met QC Criteria

April 4, 2008

First Posted (Estimate)

April 11, 2008

Study Record Updates

Last Update Posted (Estimate)

February 3, 2012

Last Update Submitted That Met QC Criteria

February 2, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-004330

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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