Telephone Counseling for Tobacco Cessation - Full Text View

Purpose

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.

Condition	Intervention
Tobacco Use Cessation	Behavioral: Brief, Structured, Telephone Counseling for Tobacco Cessation as Part of a Cardiovascular Risk Reduction Service Behavioral: Usual Care

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care
Official Title:	Evaluation of Brief, Structured, Telephone Counseling for Tobacco Cessation as Part of a Cardiovascular Risk Reduction Service

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	180
Study Start Date:	November 2011
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	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)
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	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

Arms

Assigned Interventions

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

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)

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

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489579

Locations

United States, Colorado
Clinical Pharmacy Specialist, Clinical Pharmacy Cardiac Risk Service - Kaiser Permanente of Colorado
Aurora, Colorado, United States, 80011

Sponsors and Collaborators

Kaiser Permanente

Investigators

Principal Investigator:

Alicia Cymbala, PharmD, BCPS

Kaiser Permanente

More Information

No publications provided

Responsible Party:	Deanna Kurz, Senior Project Manager for Clinical Pharmacy Research & Applied Pharmacogenomics, Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT01489579 History of Changes
Other Study ID Numbers:	CO-11-1660
Study First Received:	December 8, 2011
Last Updated:	August 29, 2012
Health Authority:	United States: Department of Health and Human Services (DHHS) United States: Food and Drug Administration United States: Kaiser Permanente Human Research Participant Protection Program United States: KP Federalwide Assurance United States: KPCO Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013