Way to Quit - Comparative Efficacy, Acceptance and Effectiveness of Health Incentive Structures
10 de maio de 2016 atualizado por: Scott Halpern, University of Pennsylvania
Using the NIH-funded Way to Health platform, the investigators will conduct this smoking cessation randomized controlled trial (RCT) among CVS employees.
The investigators will be able to determine the comparative and absolute efficacy and effectiveness of 4 different incentive structures that are each grounded in behavioral economic principles.
Additionally, the investigators will measure rates of and reasons for acceptance of each incentive structure, and examine participant characteristics that modify the efficacy and acceptance of different incentive structures.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
Specific Aim I: Compare the efficacy and effectiveness of 4 financial incentive structures for improving "quit rates" (rates of prolonged smoking abstinence for 6 months): (a) individual financial rewards, (b) individual deposit contracts, (c) cooperative rewards, and (d) competitive deposit contracts
H1: Compared with usual care, all 4 incentive structures will increase quit rates significantly.
H2: Compared with individual financial rewards of equivalent size and schedule, individual deposit contracts, cooperative rewards, and competitive contracts will each increase quit rates significantly.
H3: Group-oriented structures will increase quit rates significantly more than individual-oriented structures.
Specific Aim II: Compare smokers' acceptance of these 4 financial incentive structures for smoking cessation
H4: Uptake rates of reward-based structures will be higher than of structures involving deposit contracts.
H5: Uptake rates of group-oriented structures will be higher than of individual-oriented structures.
Specific Aim III: Identify individual characteristics that modify incentive structures' efficacy and acceptance
H6: Incentives will promote relatively greater quit rates among participants with fewer substitute reinforcers.
H7: Incentives will promote relatively greater quit rates among participants with lower incomes.
H8: Higher-income persons will be relatively more likely to accept incentives requiring deposit contracts.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
2185
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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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania
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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
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Active smoker of 5 cigarettes per day for at least 6 months;
- At least 18 years old;
- Current full- or part-time employee of CVS or be a family member or friend of a current full- or part-time employee of CVS.
Exclusion Criteria:
- Use a form of tobacco other than cigarettes while participating in the study (as this may influence biochemical testing);
- Are unable or unwilling to access the internet;
- Are unable to provide informed consent.
- Due to the web-based nature of this study, people without reliable computer and internet access will also be excluded.
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: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Usual Care
Participants will be offered free smoking cessation programs, and be provided web-based education regarding the health and economic benefits of smoking cessation.
Participants will also have the opportunity to submit weekly reports on their smoking habits.
They will be informed that they will receive reimbursements for completing the surveys that are part of the Way To Quit program and for submitting saliva or urine samples at 14 days, 30 days, 6 months, and 12 months (among those eligible).
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Participants will receive reimbursements for completing the surveys that are part of the Way To Quit program and for submitting saliva or urine samples at 14 days, 30 days, 6 months, and 12 months (among those eligible).
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Experimental: Individual Rewards
Same as USUAL CARE arm, plus financial incentive as follows: if participants quit smoking by their target quit date, and that is confirmed by cotinine or anabasine tests, they will receive a monetary award from the study investigators.
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If participants quit smoking by their target quit date, and that is confirmed by cotinine/anabasine tests, they will receive a monetary award from the study investigators.
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Experimental: Fixed Deposits
Same as USUAL CARE arm, plus financial incentive as follows: participants will have to deposit a certain monetary amount of their own money as an incentive to quit smoking.
If they quit smoking by their target quit date, and that is confirmed by cotinine or anabasine tests, participants will receive their deposit back.
If participants do not quit, their money will be used to support future research studies designed to help people stop smoking.
As a motivation to quit smoking, the participant's deposit will be matched by the study investigators in a rate of 3:1.
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Participants will have to deposit a certain monetary amount of their own money as an incentive to quit smoking.
If they quit smoking by their target quit date, and that is confirmed by cotinine/anabasine tests, participants will receive their deposit back.
If participants do not quit, their money will be used to support future research studies designed to help people stop smoking.
As a motivation to quit smoking, the participant's deposit will be matched by the study investigators in a rate of 3:1.
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Experimental: Competitive Deposits (Pari-Mutuel)
Same as USUAL CARE, plus financial incentive as follows: groups (or "cohorts") of 6 smokers each will be formed on a rolling basis, linking individuals with target quit dates (day "0's") near each other.
Participants will deposit a certain monetary amount (Y) in an account, which will be matched on a rate of 3:1 by the study investigators (M), and the payout for quitting on this arm will be (Y+M) x 6/Q , where Q is the number of quits in the cohort.
Again, success will be confirmed by cotinine or anabasine tests, and if participants do not quit, their money will be used to support future research studies designed to help people stop smoking.
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Groups (or "cohorts") of 6 smokers each will be formed on a rolling basis, linking individuals with target quit dates (day "0's") near each other.
Participants will deposit a certain monetary amount (Y) in an account, which will be matched on a rate of 3:1 by the study investigators (M), and the payout for quitting on this arm will be (Y+M) x 6/Q , where Q is the number of quits in the cohort.
Again, success will be confirmed by cotinine or anabasine tests, and if participants do not quit, their money will be used to support future research studies designed to help people stop smoking.
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Experimental: Collaborative Rewards
Same as USUAL CARE arm, plus financial incentive as follows: groups (or "cohorts") of 6 smokers each will be formed on a rolling basis, linking individuals with target quit dates (day "0's") near each other.
If participants quit smoking by their target quit date, and that is confirmed by cotinine or anabasine tests, they will receive a monetary award from the study investigators.
On top of that, participants will receive an additional monetary amount for each member of their group who also quits smoking.
These participants will interact through a chat room, which will help motivate them to quit smoking.
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Groups (or "cohorts") of 6 smokers each will be formed on a rolling basis, linking individuals with target quit dates (day "0's") near each other.
If participants quit smoking by their target quit date, and that is confirmed by cotinine or anabasine tests, they will receive a monetary award from the study investigators.
On top of that, participants will receive an additional monetary amount for each member of their group who also quits smoking.
These participants will interact through a chat room, which will help motivate them to quit smoking.
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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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Salivary cotinine or anabasine testing (metabolites of nicotine)
Prazo: at 6 months following the patient selected target quit date.
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The primary measure of smoking cessation will be prolonged abstinence for 6 months, which will be measured by salivary cotinine testing or by urinary anabasine testing (for those participants using nicotine replacement therapy).
Saliva samples will be analyzed using semi-quantitative immunochromatographic assay test strips at the University of Pennsylvania.
Urine samples will be analyzed using gas chromatography at the Associated Regional and University Pathologists (ARUP) Lab, at the University of Utah.
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at 6 months following the patient selected target quit date.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Salivary cotinine or anabasine testing (metabolites of nicotine)
Prazo: at 14 and 30 days, and 6 months following the patient selected target quit date and relapse rate 12 months after the target quit date.
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Another secondary outcome variable will be the proportion of participants achieving point prevalence abstinence at 14 days, 30 days, 6 months and 12 months after the quit date.
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at 14 and 30 days, and 6 months following the patient selected target quit date and relapse rate 12 months after the target quit date.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: David Asch, MD, MBA, University of Pennsylvania
- Investigador principal: Scott Halpern, MD, Ph.D., University of Pennsylvania, Department of Medicine, Pulmonary, Allergy and Critical Care
- Investigador principal: Kevin Volpp, MD, Ph.D., University of Pennsylvania
- Investigador principal: Benjamin French, MS, Ph.D., University of Pennsylvania
- Investigador principal: Dylan Small, Ph.D., University of Pennsylvania
- Investigador principal: Janet Audrain-McGovern, Ph.D., University of Pennsylvania
Publicações e links úteis
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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 fevereiro de 2012
Conclusão Primária (Real)
1 de novembro de 2015
Conclusão do estudo (Real)
1 de novembro de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
31 de janeiro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de fevereiro de 2012
Primeira postagem (Estimativa)
3 de fevereiro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
12 de maio de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de maio de 2016
Última verificação
1 de maio de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 814761
- R01CA159932 (Concessão/Contrato do NIH dos EUA)
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