Telephone Counseling for Tobacco Cessation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Deanna Kurz, Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01489579
First received: December 8, 2011
Last updated: August 29, 2012
Last verified: August 2012

December 8, 2011
August 29, 2012
November 2011
May 2013   (final data collection date for primary outcome measure)
The proportion of patients in each group who report a tobacco cessation attempt during the follow-up telephone survey conducted three months following pharmacist contact [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01489579 on ClinicalTrials.gov Archive Site
  • The proportion of patients in each group who participate in the Colorado Quitline (COQL) within three months of pharmacist contact [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • The proportion of patients who attend any KPCO tobacco cessation program(s)or webinar(s) within three months following contact. Classes include Stop Smoking the Basics and Freedom from Cigarettes. Webinars include Break Free and Freedom from Tobacco [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • The proportion of patients in each group who purchase tobacco cessation medication aids from KPCO pharmacies within three months following pharmacist contact. Medications include nicotine replacement therapy, bupropion, and varenicline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • The proportion of patients in each group who report tobacco abstinence during the follow-up telephone survey conducted three months following pharmacist contact [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Telephone Counseling for Tobacco Cessation
Evaluation of Brief, Structured, Telephone Counseling for Tobacco Cessation as Part of a Cardiovascular Risk Reduction Service

The purpose of this study is to determine whether giving more structured information to patients over the phone about quitting tobacco helps to increase the chance that they will try to quit. The results of this study will help provide direction in developing a more standard way of helping patients to quit.

Study Hypothesis:

Brief, structured, telephone tobacco cessation counseling delivered by clinical pharmacy specialists will significantly increase the percentage of self-reported tobacco cessation attempts compared to usual care among patients enrolled in a cardiovascular risk reduction program.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Tobacco Use Cessation
  • Behavioral: Brief, Structured, Telephone Counseling for Tobacco Cessation as Part of a Cardiovascular Risk Reduction Service
    The patients in the BST counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources ("Ready to quit" patient handout)
  • Behavioral: Usual Care
    Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations
  • Active Comparator: BST counseling group
    The patients in the BST counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources ("Ready to quit" patient handout
    Intervention: Behavioral: Brief, Structured, Telephone Counseling for Tobacco Cessation as Part of a Cardiovascular Risk Reduction Service
  • Placebo Comparator: Usual care group
    Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations
    Intervention: Behavioral: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
180
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients who meet the following criteria will be eligible for the study:

  • Enrolled in CPCRS at the time of counseling (12/11-02/12),
  • Current tobacco user as noted in KP HealthConnect as of the date of the routine CPCRS evaluation and counseling. For study purposes, tobacco use includes any use of cigarettes, pipe, cigars, snuff, and chew.
  • Continuous KPCO Denver/Boulder membership during study time period

Exclusion Criteria:

  • Patients who meet any of the following criteria will not be enrolled in the study:
  • <18 years of age,
  • Non-English speakers,
  • Deceased at time of survey, and/or
  • Unable to provide consent
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01489579
CO-11-1660
No
Deanna Kurz, Kaiser Permanente
Kaiser Permanente
Not Provided
Principal Investigator: Alicia Cymbala, PharmD, BCPS Kaiser Permanente
Kaiser Permanente
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP