Program for Research on the Outcomes of VA Education (PROVE)
1 de maio de 2018 atualizado por: Mark Schwartz, VA New York Harbor Healthcare System
Program for Research on the Outcomes of VA Education: Controlled Study of Panel Management and Microsystem Education Interventions to Improve Outcomes in Hypertension and Smoking Cessation
The PROVE aims to test the efficacy of panel management support and educational intervention in VA Primary Care Clinical Microsystems.
The study will test three increasingly intensive methods for implementing panel management strategies among health care providers in VA primary care clinics: providing only panel data, providing panel management support, and providing support plus clinical microsystem-enhancing education and training.It is hypothesized that the group receiving panel management and educational interventions will have better smoking cessation and hypertension outcomes than the group receiving only panel management assistance.
It is further supposed that the later will have better smoking cessation and hypertension patient outcomes than the data-only group.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Objective:
The specific aims for this study are: (1) to identify health professional educational and clinical microsystem determinants of outcomes for hypertension and smoking cessation in veterans. (2) to test the efficacy of three increasingly intensive methods for implementing panel management strategies among health care providers in VA primary care clinics: providing only panel data, providing panel management support, and providing support plus clinical microsystem-enhancing education and training.
Research design:
This project will consist of two phases. Phase I (one year) is the development of the necessary measurement and data infrastructure to assess health professional education, microsystem function, and clinical outcomes. In Phase 2 (two years) the study team will conduct a clinical demonstration project, comparing three interventions in a randomized controlled trial. Primary care teams will be randomly allocated to one of three arms: 1) panel management data, 2) panel management data and support, and 3) panel management data, support and education. The investigators will assess the impact of the implementation of panel management on primary patient outcomes in hypertension and smoking cessation (blood pressure and quit rates). The investigative team will also assess the impact of the implementation of panel management on secondary, intermediary, patient (patient activation, adherence, behavior change), provider (knowledge and attitudes, self-efficacy, job satisfaction) and microsystem outcomes (collective efficacy, teamwork, use of data, redesign of patient processes and provider roles/responsibilities, use of panel management strategies).
Methodology:
The study will utilize a multi-method, quasi-experimental design at VA NYHHS. Primary care is delivered through two teams at the Manhattan and five teams at the Brooklyn campuses. Patients, staff, nurses, and physicians are assigned to specific teams, thereby limiting contamination in this study.
Tipo de estudo
Intervencional
Inscrição (Real)
5000
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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New York
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Brooklyn, New York, Estados Unidos, 11209
- VA NYHHS Brooklyn Campus
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New York, New York, Estados Unidos, 10010
- VA NYHHS Manhattan Campus
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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
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- non-specialized primary care clinical microsystems
Exclusion Criteria:
- specialized clinical microsystems
- pilot clinical patient-aligned care teams
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 |
|---|---|
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Comparador Ativo: PM-Data
Team will receive data only.
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The microsystem teams of providers, nurses, and clerks will receive monthly reports of their performance measures, which will include process and outcome data for smoking cessation and blood pressure control for veterans in their panel.
The reports will provide lists of individual patients in the panel with unmet goals on VA performance measures.
They will receive written informational material describing principles and practices of panel management and evidence-based guidelines for hypertension management and smoking cessation.
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Experimental: PM-Support
Team will receive data and panel management support
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The microsystem teams of providers, nurses, and clerks will receive monthly reports of their performance measures, which will include process and outcome data for smoking cessation and blood pressure control for veterans in their panel.
The reports will provide lists of individual patients in the panel with unmet goals on VA performance measures.
They will receive written informational material describing principles and practices of panel management and evidence-based guidelines for hypertension management and smoking cessation.
PMAs will meet regularly with the members of the microsystem team for one hour/week.
The team will be asked to review progress on the health status of their patient panel and to plan strategies for improving their outcomes that the PMA will then implement.
A PMA toolkit of panel management strategies will be established that will include guidelines for using VA databases to identify care gaps and reaching out to panel patients via phone and mail to intervene (e.g.
reconnect patients to care with appointments, assess and enhance medication adherence, connect patients with VA services, motivational interviewing, and communication with the team about patient issues.
Outros nomes:
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Experimental: PM-Education
Team will receive data, panel management support, and educational interventions.
|
The microsystem teams of providers, nurses, and clerks will receive monthly reports of their performance measures, which will include process and outcome data for smoking cessation and blood pressure control for veterans in their panel.
The reports will provide lists of individual patients in the panel with unmet goals on VA performance measures.
They will receive written informational material describing principles and practices of panel management and evidence-based guidelines for hypertension management and smoking cessation.
PMAs will meet regularly with the members of the microsystem team for one hour/week.
The team will be asked to review progress on the health status of their patient panel and to plan strategies for improving their outcomes that the PMA will then implement.
A PMA toolkit of panel management strategies will be established that will include guidelines for using VA databases to identify care gaps and reaching out to panel patients via phone and mail to intervene (e.g.
reconnect patients to care with appointments, assess and enhance medication adherence, connect patients with VA services, motivational interviewing, and communication with the team about patient issues.
Outros nomes:
The educational intervention will be administered throughout the duration of the study.
Our initial educational focus will be on content (concepts of population health and panel management) and process (practice change methodology).
Subsequent education will be process oriented, reviewing the changing system of care and discussing its functioning.
Education will cover panel management strategies, microsystem theory and skills, and specific strategies regarding the management of hypertension and smoking cessation.
It will include monthly seminars, reading materials, web-based modules, and skill building workshops, and PMA-conducted monthly academic detailing using panel data and feedback.
After the first three months, academic detailing will only be implemented on an as-needed basis.
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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Change in Smoking Status
Prazo: Baseline and 12 months
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clinical outcome
|
Baseline and 12 months
|
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Change in Blood Pressure Reading
Prazo: Baseline and 12 months
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clinical outcome
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Baseline and 12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in weight
Prazo: Baseline and most recent at 12 months
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Baseline and most recent at 12 months
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Change in Patient Activation
Prazo: 6 months and 12 months
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The Patient Activation Measure (PAM) is used to assess patients' self-reported knowledge, skill, and confidence in self-managing of health and chronic conditions
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6 months and 12 months
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Change in Patient Perceptions of Quality of Care
Prazo: 6 months and 12 months
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6 months and 12 months
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Change in Provider Behavior change expertise
Prazo: 6 months and 12 months
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6 months and 12 months
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|
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Change in Provider Self-efficacy with Panel Management Tasks
Prazo: Baseline and 12 months
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Baseline and 12 months
|
|
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Change in Provider Job Satisfaction
Prazo: Baseline and 12 months
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Baseline and 12 months
|
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Change in Microsystem function and collective efficacy
Prazo: Baseline and 12 months
|
Baseline and 12 months
|
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Change in Provider's assessments of training that they received in panel management and working within a PACT team
Prazo: Baseline and 12 months
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Baseline and 12 months
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Change in Proportion of panel smokers offered smoking cessation resources by study arm
Prazo: Baseline and 12 months
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Baseline and 12 months
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Change in Proportion of smokers on the panel received any cessation medications
Prazo: Baseline and 12 months
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This information will be culled from the Vista Smoking Database
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Baseline and 12 months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Health care usage
Prazo: Baseline and 12 months
|
Number of primary care visits, mental health visits, emergency room/urgent care visits and the number of VA hospitalizations
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Baseline and 12 months
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Change in Patient-level costs
Prazo: Baseline and 12 months
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Outpatient primary care visits, mental health visits, pharmacy and hospitalizations from the VA Decision Support System
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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: Mark D Schwartz, VA New York Harbor Healthcare System
- Investigador principal: Scott Sherman, M.D., M.P.H., VA New York Harbor Healthcare System
- Diretor de estudo: Colleen Gillespie, PhD, NYU Langone Health
- Diretor de estudo: Anne Dembitzer, M.D., VA New York Harbor Healthcare System
Publicações e links úteis
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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 setembro de 2009
Conclusão Primária (Real)
31 de agosto de 2014
Conclusão do estudo (Real)
31 de agosto de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
28 de agosto de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de agosto de 2012
Primeira postagem (Estimativa)
3 de setembro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Real)
7 de maio de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de maio de 2018
Última verificação
1 de maio de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- EDU 08-428-2
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