- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01900470
Effectiveness of Patient-centered Community Health Worker Support to Help Patients Control Chronic Disease
2 de maio de 2017 atualizado por: University of Pennsylvania
Community Health Worker Support to Help Patients Control Chronic Disease
The purpose of this proposal is to compare the effectiveness of community health worker (CHW) support vs. usual primary care for helping chronically-ill, low-SES patients to improve control of chronic conditions.
Upon enrollment each patient will select one of their multiple chronic conditions as a focus for the trial and work with his/her PCP to set a chronic disease management goal.
Patients are then randomized to receive usual primary care vs. CHW support for moving towards that goal.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
302
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
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Patient of target practices for at least 1 yr defined as having one office visit within preceding 12 month
- Home ZIP code including ANY of the following: 1. 19104 2. 19131 3. 19139 4. 19143 5. 19146
- 2 or more of the following conditions: 1. Obesity (BMI greater than 30), 2. HTN (ICD9 relating to HTN in EMR), 3. DM (ICD9 relating to DM in EMR), 4. Asthma/COPD and tobacco dependence (ICD9 for asthma or COPD in EMR AND documentation of tobacco use)
- Uninsured, insured by Medicaid or dually eligible for Medicaid/Managed Medicare
- Patients who have scheduled appointments in the future.
Exclusion Criteria:
- Will not provide informed consent for this study.
- Does not have the capacity to provide informed consent for this study.
- Previously enrolled in this study
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 de grupo único
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: CHW Goal Support
IMPaCT CHWs will perform the following functions, depending on the needs of the participants: 1) Deconstructing Distal Goals into Proximal Goals: IMPaCT CHWs will help patients to deconstruct collaborative distal clinical goals into patient driven proximal goals and develop strategies for achieving each proximal goal.2) Creating Roadmaps: Roadmaps are individualized strategies for achieving each proximal goal identified by patients.
3) IMPaCT CHWs conduct weekly follow-up with patients through either telephone or home visit in order to support the achievement of proximal goals.
As part of these followup encounters, CHWs ask patients to measure their chronic disease control during their weekly followup calls/visits.
4) Group: CHWs and their Project Manager run a group session for patients in the IMPaCT arm.
This group meets weekly and is a forum for patients to discuss common issues around chronic disease management and form a social support network.
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IMPaCT CHWs will perform the following functions, depending on the needs of the participants: 1) Deconstructing Distal Goals into Proximal Goals: IMPaCT CHWs will help patients to deconstruct collaborative distal clinical goals into patient driven proximal goals and develop strategies for achieving each proximal goal.2) Creating Roadmaps: Roadmaps are individualized strategies for achieving each proximal goal identified by patients.
3) IMPaCT Partners conduct weekly follow-up with patients through either telephone or home visit in order to support the achievement of proximal goals.
As part of these followup encounters, CHWs ask patients to measure their chronic disease control during their weekly followup calls/visits.
4) Group: CHWs and their Project Manager run a group session for patients in the IMPaCT arm.
This group meets weekly and is a forum for patients to discuss common issues around chronic disease management and form a social support network.
Outros nomes:
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Sem intervenção: Usual Primary Care
Patients will be encouraged to make follow-up appointments as needed with their primary care clinic for support towards their health goals.
During these appointments, clinicians will help patients determine progress made on existing proximal goals, adjust goals based on self-efficacy, and help patients to create new proximal goals as needed.
They will also work with PCPs to adjust medications when appropriate, provide health behavior education and make referrals to community-based services based on patient need.
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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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Change in standardized score
Prazo: Six months after enrollment
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Six months after enrollment, the IMPaCT arm will have a higher (more negative) mean change in standardized score for chronic disease outcome of interest compared with usual care
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Six months after enrollment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Goal achievement
Prazo: Six months after enrollment
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Six months after enrollment, patients in the IMPaCT group will have higher proportion of patients who achieve their individualized chronic disease management goal compared with usual care
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Six months after enrollment
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SF-12
Prazo: Six months after enrollment,
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Six months after enrollment, patients in the IMPaCT group will greater improvements in their self-rated health (as measured by mean change in MCS and PCS of the SF-12) than patients receiving usual care.
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Six months after enrollment,
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CAHPS PCMH (Communication, Self-Management Support, Comprehensiveness of Care)
Prazo: Six months after enrollment
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Six months after enrollment, the IMPaCT arm will have higher perceived quality of patient-centered medical care (as measured by the Consumer Assessment of Healthcare Providers and Systems Patient-Centered Medical Home (CAHPS PCMH) survey) than the usual care arm.
Specifically, we will measure the CAHPS PCMH domains pertaining to Self-Management Support and Comprehensiveness of Care.
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Six months after enrollment
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Hospitalization
Prazo: 6 months after enrollment
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Patients in the IMpaCT arm with have a lower rate of hospitalizations than the usual care arm at 6 months after enrollment.
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6 months after enrollment
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Patient Activation
Prazo: Six months after enrollment
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Six months after enrollment, patients in the IMPaCT arm will have greater improvements in their activation (as measured by mean change in PAM score) compared with patients in the usual care arm.
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Six months after enrollment
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Hospitalizations at 12 months
Prazo: 12 months after enrollment
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Patients in the IMpaCT arm with have a lower rate of hospitalizations than the usual care arm at 12 months after enrollment.
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12 months after enrollment
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Medical Adherence
Prazo: Six months after enrollment
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Six months after enrollment, patients in the IMPaCT arm will have higher levels of adherence to medical recommendations than the usual care arm, as measured by the Medical Outcomes Study (MOS) Measures of Patient Adherence.
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Six months after enrollment
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Shreya Kangovi, University of Pennsylvania
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Kangovi S, Mitra N, Grande D, Huo H, Smith RA, Long JA. Community Health Worker Support for Disadvantaged Patients With Multiple Chronic Diseases: A Randomized Clinical Trial. Am J Public Health. 2017 Oct;107(10):1660-1667. doi: 10.2105/AJPH.2017.303985. Epub 2017 Aug 17.
- Kangovi S, Mitra N, Turr L, Huo H, Grande D, Long JA. A randomized controlled trial of a community health worker intervention in a population of patients with multiple chronic diseases: Study design and protocol. Contemp Clin Trials. 2017 Feb;53:115-121. doi: 10.1016/j.cct.2016.12.009. Epub 2016 Dec 10.
- Kangovi S, Mitra N, Smith RA, Kulkarni R, Turr L, Huo H, Glanz K, Grande D, Long JA. Decision-making and goal-setting in chronic disease management: Baseline findings of a randomized controlled trial. Patient Educ Couns. 2017 Mar;100(3):449-455. doi: 10.1016/j.pec.2016.09.019. Epub 2016 Sep 25.
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 julho de 2013
Conclusão Primária (Real)
1 de maio de 2015
Conclusão do estudo (Real)
1 de fevereiro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
11 de julho de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de julho de 2013
Primeira postagem (Estimativa)
16 de julho de 2013
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de maio de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de maio de 2017
Última verificação
1 de maio de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB 817488
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