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Title: Comparative Effectiveness of Asthma Interventions Within an AHRQ PBRN

19 de abril de 2022 atualizado por: Wake Forest University Health Sciences

Accelerating Implementation of Comparative Effectiveness Findings on Clinical and Delivery Systems by Leveraging AHRQ Networks

The overall goal is to identify best practices for improving health outcomes for patients with asthma using comparative effectiveness research within an Agency for Healthcare Research and Quality (AHRQ) Practice-Based Research Network (PBRN). This goal will be achieved by completing the following aims: (1) Create a centralized database for comparative effectiveness research on asthma by combining clinical and billing data from one of the largest healthcare systems in the country (Carolinas Healthcare System) with data from the school system, Medicaid, and patient and community-level datasets; (2) Deploy a fully developed integrated approach to asthma management based on the Chronic Care Model; (3) Develop and implement a "shared decision making" approach for asthmatic patients from disadvantaged backgrounds; (4) Implement an electronic data collection system for an existing CDC funded school-based asthma intervention that will allow program evaluation and link school nurses with providers; (5) Evaluate and compare the effectiveness of these three asthma management strategies on: overall healthcare consumption and medical costs; quality of life, school absenteeism and performance; asthma clinical measures; and medication utilization; and (6) Disseminate findings across the state via the statewide PBRN and other network partners. This project has the potential to impact over 30,000 asthma patients across the Carolinas including many patients from disadvantaged backgrounds.

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Real)

1040

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

    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28207
        • Department of Family Medicine
      • Charlotte, North Carolina, Estados Unidos, 28207
        • CMC Elizabeth Family Medicine

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

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

all with asthma diagnosis

Exclusion Criteria:

none

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: Não randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Group A - Usual Care Controls
Group A will consist of 20 primary care clinics who are part of the Carolinas Healthcare System network but have not yet adopted the Electronic Medical Record System. These practices do use the same billing databases as the remaining clinics, allowing easy identification of asthma patients and their health services utilization patterns. Data from the billing systems will be used to retrospectively populate a database for these clinics from January 2009 forward.
No EMR
Comparador Ativo: Group B - EMR Control Practices
There are currently 65 primary care practices within the Carolinas Healthcare System network that have electronic medical record with decision support (EAP)access at baseline. These practices will serve as a second level of control for comparison with the intervention groups. Each of these practices is currently using Cerner PowerChart and at the start of the study and will have access to the asthma decision support tools; an electronically generated Asthma Action Plan (AAP); and a built-in system of population management reports which will be pushed to the practices on an on-going basis to help in patient recall and management. The EAP approach to care has been developed with input from clinicians, hospital administrators, hospital information services personnel, and Cerner consultants.
Decision Support, Asthma Action Plans, and Population Management Reporting (EAP)
Comparador Ativo: C Integrated Approach to Care
There are 10 practices within the Carolinas Healthcare System (CHS) network that have already received additional training for improving outcomes for patients with chronic diseases termed the Integrated Approach to Care (IAC). This IAC approach developed by CHS is based on the Chronic Care Model (CCM). The IAC approach includes a heavy emphasis on the use of health information technology that practices receive during the initial EAP rollout.
Patients within the IAC group will also receive their own copy of an asthma action plan to allow for some degree of self-management support. In addition, IAC practices receive assistance from a practice coach trained in practice redesign and rapid cycle process improvement.
Comparador Ativo: Group D - Shared Decision Making (SDM)
This approach has great potential for improved patient outcomes and provides an additional step in the successful implementation of patient self-management. The research team will develop the SDM intervention during the first 6 months of the study. In particular, the Shared decision making (SDM) intervention will be designed to be deployed within the 4 large clinics that care for the majority of the community's underserved and disadvantaged patients. The SDM intervention development will be overseen by the study advisory board and actively recruit providers from within the clinics for feedback about the intervention.
The research team will develop the SDM intervention during the first 6 months of the study. The team will model this intervention on the randomized control trial performed by Dr. Sandra Wilson and colleagues within the Kaiser Permanente Clinics in California and Oregon
Comparador Ativo: School Based Care (SBC)
Activities included: spending individual time with students to assess, treat, and monitor and to educate students in proper asthma management; facilitate access to health care and medicine; and communicate with parents.
the research team will start an electronic data capture system linking school data and the clinical EMR (Cerner Power Chart) that will be implemented over the first year. Flow of data between schools and the hospital system will allow the children who have a regular source of care as well as those without a medical home to be treated with a unified asthma program by the school nurse and the hospital system.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Reducing Hospitalizations and Emergency Department Visits
Prazo: 2011-2013
Quality goals will be measured by the percentage of patients who reach the goal out of all patients identified with the disease through healthcare system data.
2011-2013

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Improving Adherence to Medication
Prazo: 2011-2013
Quality goals will be measured by the percentage of patients who reach the goal out of all patients identified with the disease.
2011-2013
Improve Quality of Life
Prazo: 2011-2013
Measured via Survey
2011-2013
Reduced School Absenteeism
Prazo: 2011-2013
measured with school absenteeism data
2011-2013
Improved Self-Efficacy
Prazo: 2011-2013
survey
2011-2013
Improved School Performance
Prazo: 2011-2013
measured by yearly end of grade results
2011-2013

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Michael F Dulin, MD, PhD, Wake Forest University Health Sciences

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 março de 2011

Conclusão Primária (Real)

1 de agosto de 2017

Conclusão do estudo (Real)

1 de agosto de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

19 de janeiro de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de janeiro de 2011

Primeira postagem (Estimativa)

20 de janeiro de 2011

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de abril de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de abril de 2022

Última verificação

1 de fevereiro de 2018

Mais Informações

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 .

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