- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02839382
The Northwest Coalition for Primary Care Practice Support (H2N)
12 de setembro de 2019 atualizado por: Kaiser Permanente
The purpose of this project is to build capacity for quality improvement (QI) in small primary care practices across Washington, Oregon and Idaho by improving risk factors for heart attacks such as blood pressure, cholesterol and smoking.
The Northwest Coalition for Primary Care Practice Support will assist practices by providing them with a QI coach, creating group learning opportunities, and conducting educational outreach activities.
An innovative study design will be used to determine what levels and types of support are most helpful and effective.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
The Northwest Coalition for Primary Care Practice Support will provide a comprehensive and robust external practice support infrastructure for small and medium primary care practices across Washington (WA), Oregon (OR) and Idaho (ID) to build their internal quality improvement (QI) capacity and improve performance on the heart health indicators of aspirin use, blood pressure and cholesterol control and smoking cessation (ABCS indicators) by disseminating and supporting the implementation of relevant Patient Centered Outcomes Research findings.
This coalition of partners has a remarkable track record of collaboration and improving primary care practice: the MacColl Center for Health Care Innovation and the Center for Community Health Evaluation at Group Health Research Institute; Qualis Health, the Health IT Regional Extension Center (REC) and designated Quality Improvement Organization (QIO) for WA and ID; and the Oregon Rural Practice-based Research Network (ORPRN), along with state-level partners who are membership organizations for clinicians in small practice settings.
Recruitment will leverage existing small practice relationships between Qualis Health as the health information technology (IT) REC for WA and ID and ORPRN's existing network of small practices with a goal of enrolling 320 small practices out of an estimated 1,479 with stage 1 meaningful use of their electronic health record across the three states.
In addition to providing health IT support for the Physician Quality Reporting System (PQRS) to measure the ABCS indicators in all practices, our comprehensive approach to building QI capacity and improving the ABCS measures consists of: 1) practice facilitation as a unifying strategy, 2) academic detailing/outreach to support implementation of PCOR findings, and 3) shared learning collaboratives.
We will employ an innovative study and evaluation design by providing two levels of support for each of the latter three practice support components.
By randomly assigning practices to one of eight possible combinations of practice support, we will "…develop new evidence about the contribution of various components of the comprehensive approach and the effect of the intensity of the approach on outcomes."
Our rigorous mixed-method evaluation is based on the RE-AIM framework and will employ multi-level models and interrupted time series regression.
Data will be collected from a control group of practices to examine secular trends.
Our Specific Aims are to: 1) Identify, recruit and conduct baseline assessments in 320 small to medium size primary care practices across the geographically contiguous region of WA, OR and ID; 2) Provide comprehensive external practice support to build QI capacity within these practices; 3) Disseminate and support the adoption of PCOR findings relevant to the ABCS quality measures; 4) Conduct a rigorous evaluation of the effectiveness of providing external practice support to implement PCOR findings and improve ABCS measures; and 5) Assess the sustainability of changes made in QI capacity and ABCS improvements and develop a model of dissemination and primary care practice support infrastructure.
Tipo de estudo
Intervencional
Inscrição (Real)
209
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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Washington
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Seattle, Washington, Estados Unidos, 98101
- GroupHealthCoop
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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:
- Primary care practice with 10 or fewer providers and an Electronic Health Record (EHR) that meets Stage 1 meaningful use criteria
Exclusion Criteria:
- No EHR
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 fatorial
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Coaching
External facilitation by a practice coach for 15 months
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An external facilitator or coach is assigned 15-20 primary care clinics and will make face-to-face site visits and monthly phone calls for 15 months to support building QI capacity in each assigned practcie
Outros nomes:
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Comparador Ativo: Educational Outreach
Academic detailing phone calls to support implementation of a cardiovascular risk calculator/estimator in each clinic
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An external facilitator or coach is assigned 15-20 primary care clinics and will make face-to-face site visits and monthly phone calls for 15 months to support building QI capacity in each assigned practcie
Outros nomes:
Practices randomized to this arm of the study will receive an educational outreach phone call by an academic expert on implementation strategies for use of a cardiovascular risk calculator within their daily work flow and clinic setting
Outros nomes:
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Comparador Ativo: Site Visit
Site visits made by practices to 'exemplar" practices to learn innovative approaches to quality improvement
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An external facilitator or coach is assigned 15-20 primary care clinics and will make face-to-face site visits and monthly phone calls for 15 months to support building QI capacity in each assigned practcie
Outros nomes:
Practices randomized to this arm of the study will be given an opportunity to make a site visit to an "exemplar" practice to learn about innovative approaches to conducting quality improvement activities.
Outros nomes:
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Comparador Ativo: Educational Outreach and Site Visit
In this arm of the study, practices will be offered both educational outreach and an opportunity for a site visit
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An external facilitator or coach is assigned 15-20 primary care clinics and will make face-to-face site visits and monthly phone calls for 15 months to support building QI capacity in each assigned practcie
Outros nomes:
Practices randomized to this arm of the study will receive an educational outreach phone call by an academic expert on implementation strategies for use of a cardiovascular risk calculator within their daily work flow and clinic setting
Outros nomes:
Practices randomized to this arm of the study will be given an opportunity to make a site visit to an "exemplar" practice to learn about innovative approaches to conducting quality improvement activities.
Outros nomes:
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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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Appropriate use of Aspirin
Prazo: Every 3 months with 12 month look-back
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National Quality Forum (NQF) 0068 Ischemic Vascular Disease (IVD): Use of Aspirin or another Antithrombotic
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Every 3 months with 12 month look-back
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Hypertension
Prazo: Every 3 months with 12 month look-back
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NQF 0018 Controlling hypertension
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Every 3 months with 12 month look-back
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Smoking
Prazo: Every 3 months with 12 month look-back
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NQF 0027 Smoking and Tobacco Use Cessation, Medical Assistance
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Every 3 months with 12 month look-back
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change Process Capacity
Prazo: Baseline, 15 months, 21 months
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The change process capacity questionnaire
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Baseline, 15 months, 21 months
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Quality Improvement Capacity Assessment
Prazo: Baseline and 12 months
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Practice-level consensus agreement on QI capacity
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Baseline and 12 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Michael L Parchman, MD, Kaiser Permanente
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
- Parchman ML, Fagnan LJ, Dorr DA, Evans P, Cook AJ, Penfold RB, Hsu C, Cheadle A, Baldwin LM, Tuzzio L. Study protocol for "Healthy Hearts Northwest": a 2 x 2 randomized factorial trial to build quality improvement capacity in primary care. Implement Sci. 2016 Oct 13;11(1):138. doi: 10.1186/s13012-016-0502-7.
- Fagnan LJ, Walunas TL, Parchman ML, Dickinson CL, Murphy KM, Howell R, Jackson KL, Madden MB, Ciesla JR, Mazurek KD, Kho AN, Solberg LI. Engaging Primary Care Practices in Studies of Improvement: Did You Budget Enough for Practice Recruitment? Ann Fam Med. 2018 Apr;16(Suppl 1):S72-S79. doi: 10.1370/afm.2199.
- Baldwin LM, Fischer MA, Powell J, Holden E, Tuzzio L, Fagnan LJ, Hummel J, Parchman ML. Virtual Educational Outreach Intervention in Primary Care Based on the Principles of Academic Detailing. J Contin Educ Health Prof. 2018 Fall;38(4):269-275. doi: 10.1097/CEH.0000000000000224. No abstract available.
- Tuzzio L, O'Meara ES, Holden E, Parchman ML, Ralston JD, Powell JA, Baldwin LM. Barriers to Implementing Cardiovascular Risk Calculation in Primary Care: Alignment With the Consolidated Framework for Implementation Research. Am J Prev Med. 2021 Feb;60(2):250-257. doi: 10.1016/j.amepre.2020.07.027. Epub 2020 Dec 3.
- Parchman ML, Anderson ML, Penfold RB, Kuo E, Dorr DA. The Ability of Practices to Report Clinical Quality Measures: More Evidence of the Size Paradox? J Am Board Fam Med. 2020 Jul-Aug;33(4):620-625. doi: 10.3122/jabfm.2020.04.190369.
- Parchman ML, Anderson ML, Coleman K, Michaels LA, Schuttner L, Conway C, Hsu C, Fagnan LJ. Assessing quality improvement capacity in primary care practices. BMC Fam Pract. 2019 Jul 25;20(1):103. doi: 10.1186/s12875-019-1000-1.
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 maio de 2015
Conclusão Primária (Real)
1 de maio de 2018
Conclusão do estudo (Real)
1 de maio de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
18 de julho de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de julho de 2016
Primeira postagem (Estimativa)
21 de julho de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de setembro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de setembro de 2019
Última verificação
1 de setembro de 2019
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Transtornos Mentais, Desordem Mental
- Distúrbios induzidos quimicamente
- Doenças Vasculares
- Doenças Metabólicas
- Transtornos Relacionados a Substâncias
- Distúrbios do metabolismo lipídico
- Dislipidemias
- Hipertensão
- Doenças cardiovasculares
- Transtorno do Uso de Tabaco
- Hipertensão essencial
- Hiperlipidemias
Outros números de identificação do estudo
- AHRQ 1R8HS023908-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Sim
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