Clinical trial NCT01489579: Telephone Counseling for Tobacco Cessation
Official title: Evaluation of Brief, Structured, Telephone Counseling for Tobacco Cessation as Part of a Cardiovascular Risk Reduction Service
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2011-12-09
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: While physician-delivered care may have the greatest impact on tobacco abstinence rates, recent data indicate that other health care providers such as nurses and pharmacists improve tobacco abstinence rates more than self-help and/or no intervention.5 Thus, pharmacists continue to expand their clinical practice areas to include smoking cessation interventions. A meta-analysis of studies involving pharmacist-delivered smoking cessation services found quit rates at 6 to12 months follow-up ranged from 14% to16%.6 The results of this meta-analysis demonstrate that pharmacists can successfully deliver tobacco-cessation interventions and the evidence strongly suggests they are effective in helping increase tobacco cessation rates. Proactive telephone counseling can be more effective at increasing tobacco abstinence rates than self-help or no intervention.5 Telephone counseling is an effective system to help increase tobacco abstinence rates for a variety of reasons. From the tobacco user's standpoint, there are no transportation inconveniences and fewer scheduling conflicts. In addition, receiving counseling in the privacy of one's own home provides treatment access to individuals who are less willing to seek out counseling. At Kaiser Permanente Colorado (KPCO), members with a history of CVD are enrolled in the Clinical Pharmacy Cardiac Risk Service (CPCRS). The CPCRS is a clinical pharmacy specialist-managed, physician-directed program which provides secondary prevention care to over 14,000 patients. Clinical care includes evaluating and treatment of major cardiovascular risk factors, including tobacco use, for members. Currently, CPCRS has no standard of care with regard to addressing tobacco use. Clinical pharmacy specialists working in CPCRS deliver tobacco cessation advice at their own discretion, through various methods. The purpose of this pilot study is to determine whether brief, structured, telephone tobacco cessation counseling delivered by a clinical pharmacy specialist increases the number of smoking cessation attempts compared to usual care.

Eligibility 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

Primary outcomes:
measure: The Percentage of Self-reported Tobacco Cessation Attempts Between Groups
timeFrame: 3 months
Secondary outcomes:
measure: The Proportion of Patients in Each Group Who Participate in the Colorado Quitline (COQL) Within Three Months of Pharmacist Contact
timeFrame: 3 months
measure: The Proportion of Patients Who Attend Any KPCO Tobacco Cessation Program(s)or Webinar(s) Within Three Months Following Contact.
timeFrame: 3 months
measure: The Proportion of Patients in Each Group Who Purchase Tobacco Cessation Medication Aids From KPCO Pharmacies Within Three Months Following Pharmacist Contact.
timeFrame: 3 months
measure: The Proportion of Patients in Each Group Who Report Tobacco Abstinence During at the Three Months Follow-up Telephone Survey
timeFrame: 3 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Clinical Pharmacy Specialist, Clinical Pharmacy Cardiac Risk Service - Kaiser Permanente of Colorado
state: Colorado
Study officials:
affiliation: Kaiser Permanente
name: Alicia Cymbala, PharmD, BCPS
role: PRINCIPAL_INVESTIGATOR
References: