Program for Research on the Outcomes of VA Education (PROVE)
1 de mayo de 2018 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
5000
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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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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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- non-specialized primary care clinical microsystems
Exclusion Criteria:
- specialized clinical microsystems
- pilot clinical patient-aligned care teams
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
Otros nombres:
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Experimental: PM-Education
Team will receive data, panel management support, and educational interventions.
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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.
Otros nombres:
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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Smoking Status
Periodo de tiempo: Baseline and 12 months
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clinical outcome
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Baseline and 12 months
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Change in Blood Pressure Reading
Periodo de tiempo: Baseline and 12 months
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clinical outcome
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Baseline and 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in weight
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 6 months and 12 months
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6 months and 12 months
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Change in Provider Behavior change expertise
Periodo de tiempo: 6 months and 12 months
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6 months and 12 months
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Change in Provider Self-efficacy with Panel Management Tasks
Periodo de tiempo: Baseline and 12 months
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Baseline and 12 months
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Change in Provider Job Satisfaction
Periodo de tiempo: Baseline and 12 months
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Baseline and 12 months
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Change in Microsystem function and collective efficacy
Periodo de tiempo: Baseline and 12 months
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Health care usage
Periodo de tiempo: Baseline and 12 months
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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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
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
- Director de estudio: Colleen Gillespie, PhD, NYU Langone Health
- Director de estudio: Anne Dembitzer, M.D., VA New York Harbor Healthcare System
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de septiembre de 2009
Finalización primaria (Actual)
31 de agosto de 2014
Finalización del estudio (Actual)
31 de agosto de 2015
Fechas de registro del estudio
Enviado por primera vez
28 de agosto de 2012
Primero enviado que cumplió con los criterios de control de calidad
29 de agosto de 2012
Publicado por primera vez (Estimar)
3 de septiembre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de mayo de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
1 de mayo de 2018
Última verificación
1 de mayo de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EDU 08-428-2
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .