Telephone Counseling for Tobacco Cessation
4 de dezembro de 2018 atualizado por: Kaiser Permanente
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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
192
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Colorado
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Aurora, Colorado, Estados Unidos, 80011
- Clinical Pharmacy Specialist, Clinical Pharmacy Cardiac Risk Service - Kaiser Permanente of Colorado
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: BST counseling group
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.
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The patients in the Brief, Structured, Telephone (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)
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Comparador de Placebo: 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
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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
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The Percentage of Self-reported Tobacco Cessation Attempts Between Groups
Prazo: 3 months
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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
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3 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The Proportion of Patients in Each Group Who Participate in the Colorado Quitline (COQL) Within Three Months of Pharmacist Contact
Prazo: 3 months
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Information on COQL participation was obtained from a prevention department within KPCO that tracks these data.
Report was provided to capture who from study had participated in the COQL within 3 months of pharmacist contact.
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3 months
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The Proportion of Patients Who Attend Any KPCO Tobacco Cessation Program(s)or Webinar(s) Within Three Months Following Contact.
Prazo: 3 months
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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
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3 months
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The Proportion of Patients in Each Group Who Purchase Tobacco Cessation Medication Aids From KPCO Pharmacies Within Three Months Following Pharmacist Contact.
Prazo: 3 months
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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
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3 months
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The Proportion of Patients in Each Group Who Report Tobacco Abstinence During at the Three Months Follow-up Telephone Survey
Prazo: 3 months
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The proportion of patients in each group who report tobacco abstinence during the follow-up telephone survey conducted three months following pharmacist contact
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3 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Alicia Cymbala, PharmD, BCPS, Kaiser Permanente
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de novembro de 2011
Conclusão Primária (Real)
1 de dezembro de 2014
Conclusão do estudo (Real)
1 de janeiro de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
8 de dezembro de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de dezembro de 2011
Primeira postagem (Estimativa)
9 de dezembro de 2011
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de março de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de dezembro de 2018
Última verificação
1 de dezembro de 2018
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- CO-11-1660
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Não
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
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