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临床试验/NCT01489579
NCT01489579已完成不适用

Evaluation of Brief, Structured, Telephone Counseling for Tobacco Cessation as Part of a Cardiovascular Risk Reduction Service

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2011年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
192
试验地点
2
主要终点
The Percentage of Self-reported Tobacco Cessation Attempts Between Groups

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

BST counseling group

Active Comparator

The patients in the Brief, structured, telephone tobacco cessation, BST, counseling group, will receive tobacco cessation counseling, intervention, 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.

干预措施: Telephone Counseling for Tobacco Cessation (Behavioral)

Usual care group

Placebo Comparator

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

干预措施: Usual Care (Behavioral)

结局指标

主要结局

The Percentage of Self-reported Tobacco Cessation Attempts Between Groups

时间窗: 3 months

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

次要结局

  • The Proportion of Patients in Each Group Who Participate in the Colorado Quitline (COQL) Within Three Months of Pharmacist Contact(3 months)
  • The Proportion of Patients in Each Group Who Report Tobacco Abstinence During at the Three Months Follow-up Telephone Survey(3 months)
  • The Proportion of Patients Who Attend Any KPCO Tobacco Cessation Program(s)or Webinar(s) Within Three Months Following Contact.(3 months)
  • The Proportion of Patients in Each Group Who Purchase Tobacco Cessation Medication Aids From KPCO Pharmacies Within Three Months Following Pharmacist Contact.(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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