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CATCH-UP Intervention in Increasing Cancer Screening and Prevention Care in Uninsured Patients at Community Health Centers

17 de agosto de 2020 atualizado por: Jennifer Devoe, MD, OHSU Knight Cancer Institute

Community-Based HIT Tools for Cancer Screening and Health Insurance Promotion (CATCH-UP)

This randomized research trial studies the Community-based Health Information Technology (HIT) Tools for Cancer Screening and Health Insurance Promotion (CATCH-UP) intervention in increasing cancer screening and prevention care in uninsured patients at community health centers. The CATCH-UP intervention may contribute to increased rates of insurance coverage, leading to improved cancer screening and prevention rates in community health care settings, and general recommended preventive care.

Visão geral do estudo

Descrição detalhada

PRIMARY OBJECTIVES:

I. Evaluate the effect of the CATCH-UP intervention on up-to-date status of cancer screening and preventive care received by patients.

II. Evaluate the effect of the CATCH-UP intervention on patients? insurance coverage rates.

III. Evaluate the intervention implementation process, patient and community health center (CHC) staff acceptance and use of the CATCH-UP tools, and the patient-, provider-, and system-level factors associated with successful implementation and sustainability of the tools, using mixed methods.

OUTLINE: CHC clinics are randomized to 1 of 2 groups. We compare between groups and with a matched-comparison group.

GROUP I (INTERVENTION ARM 1): Participants receive CATCH-UP tools which include a panel management/data aggregator system that identifies patients who may be eligible for public coverage but are not yet insured, or who are nearing coverage expiration, coupled with automated patient outreach and communication at baseline.

GROUP II (INTERVENTION ARM 2): Participants receive CATCH-UP tools which include a panel management/data aggregator system that identifies patients who may be eligible for public coverage but are not yet insured, or who are nearing coverage expiration, coupled with automated patient outreach and communication. Participants also receive additional implementation support such as trainings, assistance with workflows, and practice facilitation.

Matched-comparison group: A clinic-level matched comparison group will be derived from the OCHIN membership by using propensity score matching techniques. Comparison group clinics will not participate actively in any study activities but, as part of their member business associate agreement with OCHIN, have already agreed to provide data through OCHIN for pre- and post-implementation analysis in the study.

Tipo de estudo

Observacional

Inscrição (Real)

45

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

    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • OHSU Knight Cancer Institute

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

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients with at least one encounter at a CHC in the OCHIN network since January 1, 2012

Descrição

Inclusion Criteria:

  • Established patients at CHC sites
  • Low-income
  • Ethnically diverse populations with lower rates of cancer screening compared to national rates
  • Uninsured patients
  • Patients 18 to 64 years of age
  • Clinics must be primary care sites, with greater than 1,000 adult patients in the past year, be located in a state that expanded Medicaid, and have implemented the OCHIN EHR prior to January 1, 2012

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

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Arm I (Independent Tool Implementation)
Participants receive CATCH-UP tools which include a panel management/data aggregator system that identifies patients who may be eligible for public coverage but are not yet insured, or who are nearing coverage expiration, coupled with automated patient outreach and communication at baseline.
Receive CATCH-UP intervention
Arm II (Tool Implementation with Interactive Facilitation)
Participants receive CATCH-UP tools which include a panel management/data aggregator system that identifies patients who may be eligible for public coverage but are not yet insured, or who are nearing coverage expiration, coupled with automated patient outreach and communication. Participants also receive additional implementation support such as trainings, assistance with workflows, and practice facilitation.
Receive CATCH-UP intervention

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Changes in the proportion of clinic patients who receive age- and gender-appropriate recommended cancer screening and preventive care (clinic-level)
Prazo: Baseline to up to 6 years
Pre- and post-implementation differences in proportion of patients with insurance continuity will be calculated between implementation and control community health centers (?difference-in-differences? analysis). Generalized linear/non-linear mixed models will be used, which offer flexible regression modeling to accommodate different sources of correlations (serial and intra-clinic), categorical and continuous covariates, and fixed and time-dependent covariates.
Baseline to up to 6 years
Changes in the proportion of clinic patients with insurance continuity
Prazo: Baseline to up to 6 years
Pre- and post-implementation differences in proportion of patients with insurance continuity will be calculated between implementation and control community health centers (?difference-in-differences? analysis). Generalized linear/non-linear mixed models will be used, which offer flexible regression modeling to accommodate different sources of correlations (serial and intra-clinic), categorical and continuous covariates, and fixed and time-dependent covariates. Serial and intra-clinic correlations will be modeled as random effects.
Baseline to up to 6 years
Total number of months uninsured (total gap months)
Prazo: Up to 6 years
The Community-based Health Information Technology (HIT) Tools for Cancer Screening and Health Insurance Promotion tool?s impact on total number of months uninsured (total gap months) will be evaluated. The distribution of total gap months will be examined before selecting a specific model to use for the analysis. Analytic models will be refined through an iterative process, guided by the hypotheses and preliminary analyses.
Up to 6 years

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Jennifer DeVoe, OHSU Knight Cancer Institute

Publicações e links úteis

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Publicações Gerais

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 (Real)

1 de julho de 2014

Conclusão Primária (Real)

30 de junho de 2020

Conclusão do estudo (Real)

30 de junho de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

23 de janeiro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de fevereiro de 2015

Primeira postagem (Estimativa)

4 de fevereiro de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

19 de agosto de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de agosto de 2020

Última verificação

1 de agosto de 2020

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • IRB00009862 (Outro identificador: OHSU Knight Cancer Institute)
  • NCI-2014-02326 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • CR00024554
  • 5219
  • MR00042926
  • MR00044877
  • R01CA181452 (Concessão/Contrato do NIH dos EUA)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Informational Intervention

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