Quitline Use in Surgical Patients
Primary Purpose
Tobacco Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard brief advice
Quitline intervention
Sponsored by
![Mayo Clinic](https://trials-media.s3.amazonaws.com/orgs/mayo-clinic.jpeg)
About this trial
This is an interventional prevention trial for Tobacco Dependence focused on measuring surgical patients, cigarette smoking, postoperative complications, telephone counseling, quitlines
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Brief assistance with smoking abstinence
Brief intervention to promote quitline utilization
Outcomes
Primary Outcome Measures
Completion of one quitline counseling session
Secondary Outcome Measures
Smoking behavior at six months postoperatively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00656500
Brief Title
Quitline Use in Surgical Patients
Official Title
Increasing QUITPLAN Helpline Utilization in Surgical Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence
Keywords
surgical patients, cigarette smoking, postoperative complications, telephone counseling, quitlines
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Brief assistance with smoking abstinence
Arm Title
2
Arm Type
Experimental
Arm Description
Brief intervention to promote quitline utilization
Intervention Type
Behavioral
Intervention Name(s)
Standard brief advice
Intervention Description
Brief general assistance with smoking cessation
Intervention Type
Behavioral
Intervention Name(s)
Quitline intervention
Intervention Description
Brief intervention designed specifically to encourage quitline utilization
Primary Outcome Measure Information:
Title
Completion of one quitline counseling session
Time Frame
Three months postoepratively
Secondary Outcome Measure Information:
Title
Smoking behavior at six months postoperatively
Time Frame
six months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David O. Warner, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21317630
Citation
Warner DO, Klesges RC, Dale LC, Offord KP, Schroeder DR, Shi Y, Vickers KS, Danielson DR. Clinician-delivered intervention to facilitate tobacco quitline use by surgical patients. Anesthesiology. 2011 Apr;114(4):847-55. doi: 10.1097/ALN.0b013e31820d868d.
Results Reference
derived
Learn more about this trial
Quitline Use in Surgical Patients
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