Quitline Use in Surgical Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Warner, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00656500
First received: April 4, 2008
Last updated: February 2, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Tobacco Dependence
Behavioral: Standard brief advice
Behavioral: Quitline intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Increasing QUITPLAN Helpline Utilization in Surgical Patients

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Completion of one quitline counseling session [ Time Frame: Three months postoepratively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Smoking behavior at six months postoperatively [ Time Frame: six months postoperatively ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: July 2007
Study Completion Date: June 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656500

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: David O. Warner, M.D. Mayo Clinic
  More Information

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Warner, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00656500     History of Changes
Other Study ID Numbers: 06-004330
Study First Received: April 4, 2008
Last Updated: February 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
surgical patients
cigarette smoking
postoperative complications
telephone counseling
quitlines

ClinicalTrials.gov processed this record on September 22, 2014