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- Ensaio Clínico NCT02351609
Patient Navigation and Financial Incentives to Promote Smoking Cessation
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Cigarette smoking is a highly significant health threat, responsible for > 480,000 deaths in the US each year, many due to cancer, and is the largest cause of preventable morbidity and mortality in the US. Primary care settings provide an opportunity to reach large proportions of low-income smokers, as 61% of such smokers are engaged in medical care. The proposed project addresses this under-utilization of available smoking cessation services which is occurring despite considerable interest among low-income patients about quitting/receiving help with quitting. This intervention has the potential to increase the reach of existing services and in turn, to improve the public's health.
Patient financial incentives, while not yet used as standard of care for health promotion, are in the research stage for various types of conditions. Financial incentives are effective in promoting smoking cessation; but have not been extensively studied among low SES smokers. Financial incentives are a behavioral economic intervention that is effective in promoting smoking cessation, increasing cessation rates 3-fold compared to no incentives. The investigators believe financial incentives merit further study, particularly in low SES populations. Incentives for completing smoking cessation programs/achieving abstinence may be particularly effective among low SES smokers because they: 1) can alleviate some of the financial strain that prevents low SES smokers from quitting (studies have shown that the stress from financial problems prevents patients from quitting, even though quitting smoking could save people large amounts of money); 2) promote short-term abstinence among smokers with mental illness and substance use, many of whom are low SES smokers; 3) provide a substitute reinforcer for smoking (e.g., in lieu of hobbies, physical activity, work satisfaction) often absent in environments of low SES smokers and 4) provide extrinsic motivation for patients to quit smoking, and may be particularly effective among low SES smokers, many of whom in our recent pilot study were found to have low levels of intrinsic motivation. Our strategy is to combine financial incentives with patient navigation, as the latter may "supercharge" the former, for the two interventions may work in complementary ways. The investigators posit that incentives will augment people's willingness to connect with a navigator, and the navigator will put people in touch with resources/environments in which the incentives can work.
Patient navigation holds promise as an intervention to reduce cancer disparities, but alone may be insufficient to promote smoking cessation. Patient navigators are often lay persons from the community who guide patients through the health care system so that they receive appropriate services. While patient navigation has been shown to be an effective intervention to reduce health care disparities, prior patient navigation studies have been limited to the realms of cancer screening and diagnosis. Preliminary findings from our pilot RCT of patient navigation to promote smoking cessation among low SES and minority primary care patients at Boston Medical Center suggest that a more potent intervention may be needed. While a patient navigator was able to link 37% of patients to treatment, she was unable to contact or meaningfully connect with 53% of patients. Thus, financial incentives may be used to increase participant motivation to connect with patient navigators.
Combining financial incentives with patient navigation may be an effective approach to promote cessation among low SES and minority smokers. Multicomponent interventions have shown the most promise in changing health behaviors in general, and in reducing health disparities. Barriers to behavior change among socially disadvantaged persons may be so large that no single intervention can be effective. The investigators have therefore chosen to implement two intervention components, financial incentives and patient navigation, which have shown some promise in smoking cessation, and are currently being applied in the health disparities field to other health conditions.
Our objectives and hypotheses are:
Specific Aim I: To determine whether patient navigation and financial incentives increase the rates at which primary care patients engage in smoking cessation treatment.
H1: Compared to control patients, those assigned to the intervention will be more likely to engage in smoking cessation treatment at six months post-enrollment.
Specific Aim II: To determine whether patient navigation and financial incentives increase the rates at which primary care patients quit smoking (our primary outcome), defined as biochemically confirmed cessation at twelve months using salivary cotinine levels.
H1: Compared to ETC patients, those assigned to the patient navigation/financial incentives intervention will be more likely to be abstinent at 12 months post-enrollment.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Boston Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
(1) age ≥ 18; (2) smoked ≥10 cigarettes/day in the past week; (3) have a scheduled visit with a PCP at BMC on the day of enrollment or within the next six months; (4) telephone access (5) English speaking; (6) plan on quitting smoking within the next six months; (7) able and willing to participate in the study protocol and provide informed consent.
Exclusion Criteria:
(1) planning to move out of the area within the next six months; (2) cognitive impairments that preclude participation in study activities; (3) severe illness or distress; (4) inability to read/understand English; (5) actively using evidence-based smoking cessation treatment; (6) transient residence or lack of a telephone for follow-up assessments.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Intervention
Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of resources for smoking cessation.
Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 6-month period.
Patients will receive financial incentives for biochemically confirmed smoking cessation.
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Intervention patients will be introduced to the patient navigator either in person or by telephone. The intervention patients will receive navigation from one of two trained navigators, based centrally in the Section of General Internal Medicine. The purpose of the patient navigation interactions is to 1) connect patients to existing yet underutilized smoking cessation resources and 2) increase patient commitment to follow through with existing treatment services. Financial incentives: $250 for biochemically confirmed abstinence within six months after study enrollment, and $500 for biochemically confirmed abstinence for an additional six months after the initial cessation. |
Comparador Ativo: Enhanced Traditional Care control
Patients receive information about smoking cessation resources and an educational brochure developed by the Massachusetts Department of Public Health.
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List of smoking cessation resources and educational brochure.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Smoking abstinence at 12 months post-enrollment
Prazo: 12 months
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12 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Karen Lasser, MD, Boston Medical Center
Publicações e links úteis
Publicações Gerais
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Outros números de identificação do estudo
- H-3296
- 125785-RSG-14-034-01CPPB (Número de outro subsídio/financiamento: American Cancer Society)
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