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Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorder With Chronic Direct Acting Antiviral Treatment

5 de maio de 2016 atualizado por: VA Office of Research and Development

Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorders With Chronic Hepatitis C Receiving Direct Acting Antiviral Treatment

To determine the effect of an integrated care protocol on antiviral treatment and sustained virologic response (SVR) rates following initiation of direct acting antiviral therapies (DAA) treatments in 2011.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Background and aims: Approval of direct acting antiviral (DAA) therapies in 2011 initiated a new era of more effective treatments for hepatitis C (HCV). The impact of more effective therapies on patient access to treatment is unknown. Integrated Care (IC) involving patient case management may overcome barriers to treatment access imposed by psychiatric and substance use disorders (SUD).

Methods: Prospective, randomized trial at a single medical center. Patients with HCV at risk for active psychiatric and SUD between Jan 2012 and Jan 2013 were recruited and randomized to IC or Usual Care (UC). A mid-level mental health practitioner was placed in the IC clinic and provided brief mental health care and case management.

Tipo de estudo

Intervencional

Inscrição (Real)

83

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

  • Estados Unidos
    • California
      • San Diego, California, Estados Unidos, 92161
        • VA San Diego Healthcare System, San Diego, CA

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 a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Patients with HCV infection who were referred to the VA HCV clinic and who received the usual initial evaluation in the clinic
  • All patients 18 and 75 years old with confirmed HCV infection
  • Patients were required to be classified as "high risk candidates for antiviral treatment" on any one of a set of screening measure in order to participate

  • Screening measures and cutoffs for inclusion were depression:

    • Beck Depression Inventory: (BDI) > 10
    • Alcohol use: Alcohol Use Disorders Identification Test (AUDIT-C) > 4
    • PTSD: VA Primary Care PTSD Screen = endorsement of three or more items or any single endorsement of item #3
    • Drug use: Drug Use Questionnaire = self-reported drug/alcohol use within 6 months prior to screen

Exclusion Criteria:

  • Lacked a confirmed test of HCV RNA
  • Had HIV/HCV co-infection and received care at San Diego or Palo Alto sites (these patients were treated in a separate clinic)
  • Had Hepatitis B (HBV) co-infection
  • Had decompensated liver disease with active or recent encephalopathy, variceal bleeding, or ascites or Child-Pugh class B or C
  • Had other significant near term life-threatening diseases
  • Were treatment non-responders with pegylated Interferon plus ribavirin

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: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Integrated Care
Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.
Comportamental: Brief mental health interventions and case management
The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians.
Sem intervenção: Usual Care
The usual care group received "standard of care" required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Sustained Viral Response (SVR)
Prazo: up to 24 weeks
The primary outcome for the study was the proportion of patients that achieve an SVR. Patient adherence to completing the prescribed therapy and SVR were both tracked with medical records. Viral load at 4, 12-and 24-weeks during treatment initiation have been shown to predict final SVR. Final SVR data consists of viral tests conducted at 6 months after the termination of therapy.
up to 24 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants With Treatment Initiation and Completion
Prazo: up to 24 weeks
The main secondary outcomes for the study include rates of Interferon-based treatment initiation and completion. Treatment data from the HCV clinics were reviewed for each patient at each site. Participants who a) filled at least one prescription for Interferon and ribavirin, and b) had at least one treatment-related physician visit with a medical record note stating they began taking the medications were deemed to have initiated antiviral treatment. Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.
up to 24 weeks
Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80%
Prazo: up to 24 weeks
Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.
up to 24 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

VA Office of Research and Development

Investigadores

  • Investigador principal: Samuel B Ho, MD, VA San Diego Healthcare System, San Diego, CA

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 janeiro de 2012

Conclusão Primária (Real)

1 de janeiro de 2013

Conclusão do estudo (Real)

1 de fevereiro de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

21 de dezembro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de janeiro de 2016

Primeira postagem (Estimativa)

6 de janeiro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

20 de maio de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 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

  • IIR 07-101-A

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