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Implementation of an Integrated Primary Care Network for Prevention and Management of Cardiometabolic Risks (RCM)

29 de marzo de 2011 actualizado por: Public Health Department, Montreal

Implementation of an Integrated Primary Care Network for Prevention and Management of Cardiometabolic Risks (RCM)

CONTEXTE: L'Agence de la santé et des services sociaux de Montréal (ASSS) invited our research team to evaluate the implementation of an integrated and interdisciplinary primary care network for prevention and management of cardiometabolic risks (diabetes and hypertension) (PCR). The intervention is based on the Chronic Care Model and the development of an integrated services network. PCR is to be implemented in 6 territories of "Centre de santé et de services sociaux (CSSS)". A first application for funding was made to Fonds Pfizer-FRSQ-MSSS for an evaluation that has to be completed in the first 24 month after the beginning of the implementation. This application to the PHSI program at CIHR is complementary and will ensure an evaluation of the sustainability of PCR and of long term effects (40 months after the beginning of the implementation) for patients and for their primary care physicians.

In each CSSS, PCR plans for : 1- an interdisciplinary team in an education center working with primary care physicians and offering to referred patients a pre-determined sequence of clinical interventions over a 2-year-period; 2- a program supporting primary care physicians (continuing education, documentation and clinical guidelines, referral system to second line of care); 3- networking between actors of "Réseau local de services (RLS)" insuring clinical information transfer required for efficient patient management.

OBJECTIVES: 1-evaluate PCR effects according to territory, time and degree of exposure (specifically benefits to registered patients and support to participating primary care physicians); 2- identify the degree of implementation of PCR in each CSSS territory and the related contextual factors; 3- examine the relationship between the effects identified, the degree of implementation of PCR and the related contextual factors; 4- assess the impact of implementing PCR on the strengthening of RLS.

METHODS: The proposed evaluation will be done through a mixed design including two complementary strategies. Using a "quasi-experiment/before-after" design, the first strategy is a quantitative approach looking at the program effects and their variation between territories. This analysis will use data from the PCR clinical database (ex.: HbA1c, BP, lifestyle) and from patient questionnaire inquiring about care experience, utilization of services, chronic care follow-up, self-management and quality of life. Around 3000 patients will be enlisted. A primary care physician questionnaire will enquire about PCR effects on their practice. Using primarily a qualitative and a case study approach, each of the 6 territories being one case, the second strategy will identify the degree of implementation of PCR and the explanatory contextual factors. This analysis with use data obtained from semi-structured interviews with program managers. The results of this analysis will be summarized in a monograph for each territory. According to the type of indicator analyzed, objective 3 will be fulfilled using linear models or longitudinal multilevel models supplemented with an interpretive approach using the information from monographs and discussion groups. The impact of implementing PCR on RLS will be assessed through interviews with key informants.

RESULTS AND EXPECTED IMPACT: Our study will identify the effectiveness of PCR and contextual factors associated with successful implementation and sustainability of PCR. Detailed contextual information will allow application of our results to other environments that have similar context and to other chronic conditions that could benefit from an integrated services network.

KNOWLEDGE TRANSFER: Since decision makers, clinicians and researchers did and will take part in all phases of PRC evaluation (planning, data collection, analysis and interpretation), diffusion of information regarding the program is an integral part of the research process. In addition, results will be presented at local, regional, provincial and national conferences and published in reports and articles widely distributed. More specifically, a regional symposium will be organized to share evaluation results with all CSSS in the region (n=12) and with all our local and regional partners.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

3000

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.

Estudio Contacto

  • Nombre: Pierre Tousignant Tousignant, MD
  • Número de teléfono: 3569 514-528-2400
  • Correo electrónico: ptousi@santepub-mtl.qc.ca

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • Quebec
      • Montreal, Quebec, Canadá, H2L 1M3
        • Public Health Department
        • Contacto:
        • Investigador principal:
          • Pierre Tousignant, MD

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Diabetic adults with borderline fasting blood sugar or glucose intolerance or treated with diet only or treated with only one medication or treated with multiple medications but with Hb A1c ≤ 8%;
  • Adults with blood pressure in office ≥ 140/90 mm Hg (if diabetes present, BP ≥ 130/80 mm Hg)

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: Prevención
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Chronic care management 1
Content of chronic care model implemented in territory 1 and level of implementation
1- an interdisciplinary team in an education center working with primary care physicians and offering to referred patients a pre-determined sequence of clinical interventions over a 2-year-period; 2- a program supporting primary care physicians (continuing education, documentation and clinical guidelines, referral system to second line of care); 3- networking between actors insuring clinical information transfer required for efficient patient management.
Comparador activo: Chronic care management 2
Content of chronic care model implemented in territory 2 and level of implementation
1- an interdisciplinary team in an education center working with primary care physicians and offering to referred patients a pre-determined sequence of clinical interventions over a 2-year-period; 2- a program supporting primary care physicians (continuing education, documentation and clinical guidelines, referral system to second line of care); 3- networking between actors insuring clinical information transfer required for efficient patient management.
Comparador activo: Chronic care management 3
Content of chronic care model implemented in territory 3 and level of implementation
1- an interdisciplinary team in an education center working with primary care physicians and offering to referred patients a pre-determined sequence of clinical interventions over a 2-year-period; 2- a program supporting primary care physicians (continuing education, documentation and clinical guidelines, referral system to second line of care); 3- networking between actors insuring clinical information transfer required for efficient patient management.
Comparador activo: Chronic care management 4
Content of chronic care model implemented in territory 4 and level of implementation
1- an interdisciplinary team in an education center working with primary care physicians and offering to referred patients a pre-determined sequence of clinical interventions over a 2-year-period; 2- a program supporting primary care physicians (continuing education, documentation and clinical guidelines, referral system to second line of care); 3- networking between actors insuring clinical information transfer required for efficient patient management.
Comparador activo: Chronic care management 5
Content of chronic care model implemented in territory 5 and level of implementation
1- an interdisciplinary team in an education center working with primary care physicians and offering to referred patients a pre-determined sequence of clinical interventions over a 2-year-period; 2- a program supporting primary care physicians (continuing education, documentation and clinical guidelines, referral system to second line of care); 3- networking between actors insuring clinical information transfer required for efficient patient management.
Comparador activo: Chronic care management 6
Content of chronic care model implemented in territory 6 and level of implementation
1- an interdisciplinary team in an education center working with primary care physicians and offering to referred patients a pre-determined sequence of clinical interventions over a 2-year-period; 2- a program supporting primary care physicians (continuing education, documentation and clinical guidelines, referral system to second line of care); 3- networking between actors insuring clinical information transfer required for efficient patient management.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Diabetes and Hypertension control
Periodo de tiempo: 24 months after registration
Biomedical indicators of diabetes (Hb A1c ≤7%) and hypertension (blood pressure ≤ 140/90) control
24 months after registration

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Effects on patient's behavior
Periodo de tiempo: 24 months after registration
Life-style improvement (physical activity, nutrition, smoking)
24 months after registration
Effects on patient's autonomy
Periodo de tiempo: 24 months after registration
Self-care
24 months after registration
Effects on patient's health
Periodo de tiempo: 24 months after registration
Quality of live
24 months after registration
Effects on follow-up of chronic diseases
Periodo de tiempo: 24 months after registration
Chronic care management
24 months after registration
Effects on process of care
Periodo de tiempo: 24 months after registration
Indexes of continuity, accessibility, comprehensiveness and perceived quality of care
24 months after registration
Effects on physician practice
Periodo de tiempo: 24 months after registration
Physician perception regarding effects of program on patients, inter-professional collaboration, development of knowledge, management of diabetes and hypertension
24 months after registration

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Pierre Tousignant, MD, Public Health Department, Montreal

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

1 de abril de 2011

Finalización primaria (Anticipado)

1 de junio de 2014

Finalización del estudio (Anticipado)

1 de junio de 2014

Fechas de registro del estudio

Enviado por primera vez

28 de marzo de 2011

Primero enviado que cumplió con los criterios de control de calidad

29 de marzo de 2011

Publicado por primera vez (Estimar)

30 de marzo de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

30 de marzo de 2011

Última actualización enviada que cumplió con los criterios de control de calidad

29 de marzo de 2011

Última verificación

1 de marzo de 2011

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • RisqueCardioMetabolique
  • FRSQ 22425 (Otro identificador: Fonds de la recherche en santé du Québec)

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. .

Ensayos clínicos sobre Chronic care management 1-6

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