Quitline Use in Surgical Patients

Tobacco Dependence Clinical Trial

Official title:

Increasing QUITPLAN Helpline Utilization in Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656500
• Other study ID #: 06-004330
• Status: Completed
• Phase: N/A
• First received: April 4, 2008
• Last updated: February 2, 2012
• Start date: July 2007
• Est. completion date: June 2011

Study information

• Verified date: February 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tobacco Dependence

Intervention

Behavioral:
• Standard brief advice
Brief general assistance with smoking cessation
• Quitline intervention
Brief intervention designed specifically to encourage quitline utilization

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of one quitline counseling session		Three months postoepratively	No
Secondary	Smoking behavior at six months postoperatively		six months postoperatively	No