Addiction Health Evaluation And Disease Management (AHEAD) Study
Linkage of Alcohol Abusers to Primary Care
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Chronic disease management (CDM) is a collaborative, longitudinal, proven effective approach to the treatment of chronic medical illnesses that addresses individual patient and health systems barriers to receipt of needed treatment. The objective of this Addiction Health Evaluation And Disease management (AHEAD) Study is to test the effectiveness of CDM for substance dependence in primary care. The study will enroll and randomize subjects to attend a substance dependence CDM program (the AHEAD Unit) integrated into a real-world primary care clinic or to referral to usual primary care. All subjects will be assessed regarding alcohol and/or drug diagnosis, consumption and problems, readiness to change, health-related quality of life, and medical and substance abuse treatment utilization. Primary outcomes are alcohol and drug use, alcohol and drug-related problems, emergency department visits, and hospitalizations. Additional outcomes are health-related quality of life, readiness to change, medical and psychiatric comorbidity, HIV risk behaviors, and treatment utilization and costs. The hypothesis is that compared with standard care, a health services intervention -- chronic disease management for alcohol and drug dependence integrated in primary care -- will decrease alcohol and drug use and related problems, and improve health care utilization patterns.
This study contains two studies (and study populations):
- 1. 320 alcohol dependent subjects with current risky drinking, and
- 2. 320 drug dependent subjects with current drug use.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Boston Medical Center / Boston University
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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:
- 18 years of age or older
- Fluent in English or Spanish
- Alcohol or drug dependent
- Heavy drinking in the past 30 days or recent drug use
- Provide 2 contacts to assist with follow-up
- Have no plans to move from the local area within a year of screening
- Score >21 on Mini-Mental State Examination (no serious cognitive impairment)
Exclusion Criteria:
- Pregnant (self-report)
- Breath alcohol >100 mg/dL
- Inability to provide informed consent determined by trained research associates
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 1) CDM
Chronic Disease Management
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Referral to primary medical care & longitudinal, multidisciplinary care for persons with substance dependence.
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Comparador Ativo: 2) Standard care
Standard care
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Referral to primary medical care for persons with substance dependence.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Alcohol and drug use
Prazo: 3, 6, and 12 months after baseline
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3, 6, and 12 months after baseline
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Alcohol and drug-related problems
Prazo: 3, 6, and 12 months after baseline
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3, 6, and 12 months after baseline
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Nights Hospitalized
Prazo: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
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3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
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Emergency department visits
Prazo: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
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3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Health-related quality of life
Prazo: 3, 6, and 12 months after baseline
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3, 6, and 12 months after baseline
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Readiness to change
Prazo: 3, 6, and 12 months after baseline
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3, 6, and 12 months after baseline
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Medical comorbidity
Prazo: 3, 6, and 12 months after baseline
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3, 6, and 12 months after baseline
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Psychiatric comorbidity
Prazo: 3, 6, and 12 months after baseline
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3, 6, and 12 months after baseline
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HIV risk behaviors
Prazo: 3, 6, and 12 months after baseline
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3, 6, and 12 months after baseline
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Treatment utilization and costs
Prazo: 3, 6, and 12 months after baseline, and up to 2 years after the last subject is enrolled
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3, 6, and 12 months after baseline, and up to 2 years after the last subject is enrolled
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Park TW, Samet JH, Cheng DM, Winter MR, Kim TW, Fitzgerald A, Saitz R. The prescription of addiction medications after implementation of chronic care management for substance dependence in primary care. J Subst Abuse Treat. 2015 May;52:17-23. doi: 10.1016/j.jsat.2014.11.008. Epub 2014 Dec 2.
- Park TW, Cheng DM, Samet JH, Winter MR, Saitz R. Chronic care management for substance dependence in primary care among patients with co-occurring disorders. Psychiatr Serv. 2015 Jan 1;66(1):72-9. doi: 10.1176/appi.ps.201300414. Epub 2014 Nov 17.
- Saitz R, Cheng DM, Winter M, Kim TW, Meli SM, Allensworth-Davies D, Lloyd-Travaglini CA, Samet JH. Chronic care management for dependence on alcohol and other drugs: the AHEAD randomized trial. JAMA. 2013 Sep 18;310(11):1156-67. doi: 10.1001/jama.2013.277609.
- D'Amore MM, Cheng DM, Allensworth-Davies D, Samet JH, Saitz R. Disparities in safe sex counseling & behavior among individuals with substance dependence: a cross-sectional study. Reprod Health. 2012 Dec 31;9:35. doi: 10.1186/1742-4755-9-35.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SAI-010870-06A2
- P60AA013759 (Concessão/Contrato do NIH dos EUA)
- NIAAA Grant 2R01 AA010870-06A2
- NIDA Grant 2R01 DA010019-07A1
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Ensaios clínicos em Chronic Disease Management for substance abuse
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University of WashingtonNational Center for Complementary and Integrative Health (NCCIH)Ativo, não recrutando