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Southwest Health Extension Partnership to Enhance Research Dissemination

22 de enero de 2021 actualizado por: University of Colorado, Denver
Heart disease and strokes cause one in three deaths reported each year in the United States. Primary care practices need to implement new research findings that help decrease patients' risk for heart disease and stroke. This project will help to build primary care practice capacity for quality improvement and change management in small and medium size primary care practices in Colorado and New Mexico. This project will also help practices implement patient-centered outcomes research findings.

Descripción general del estudio

Descripción detallada

Cardiovascular disease (CVD) causes one in three deaths reported each year in the United States. Strategies derived from patient-centered outcomes research (PCOR) that address CVD risk factors can greatly reduce the burden of CVD. Primary care practices must transform to deliver a higher level of PCOR evidence-based prevention to decrease cardiovascular risk. PCOR interventions that emphasize patient-centered care including self-management support, team-based care, improved information systems, and active quality improvement have been shown to be effective. Practices often require assistance integrating new programs into clinical operations. Practice facilitation has been shown to enhance implementation of new programs for patients with chronic disease in primary care. Other methods of practice support, including academic detailing, collaborative learning sessions, and health information technology assistance, have also been shown to be effective, by themselves and in combination with practice facilitation. Patient involvement may also aid practice transformation. Increasingly, practices are actively including patients as part of the change process through the creation of patient advisory councils and including patients in practice quality improvement teams. Another method of patient involvement to inform implementation of evidence-based care is the Boot Camp Translation process, in which patients collaborate with primary care clinicians, staff members, and community members to translate best practices into culturally and community relevant implementation at the local level. However, while these efforts have had considerable success, no study has looked at the incremental value of adding patient engagement strategies to the more standard approaches to practice transformation listed above. This project would implement the Southwest Health Extension Program to Enhance Research Dissemination (SHEPERD) as a cooperative program to build primary care practice capacity for quality improvement, change management, and implementation of PCOR findings in small and medium size primary care practices in Colorado and New Mexico, with an initial focus on cardiovascular care. It also would conduct a cluster randomized trial with an external matched cohort control group to examine the Reach, Effectiveness, Adoption, Implementation, and Maintenance of two approaches to practice transformation to implement PCOR interventions for reducing cardiovascular risks in primary care practices, comparing the impact of 1) a standard practice transformation support intervention (including practice facilitation, practice assessment with feedback, HIT assistance, academic detailing, and collaborative learning sessions) to 2) an approach that adds patient engagement activities (including patient advisory councils and boot camp translation) as part of the practice transformation support. This project will provide critical information regarding the added value of patient engagement in practice transformation efforts and will also result in a network of practices across the region with increased capacity for practice transformation and implementation of PCOR findings.

Tipo de estudio

Intervencionista

Inscripción (Actual)

5508

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

    • Colorado
      • Denver, Colorado, Estados Unidos
        • University of Colorado, Denver

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 a 89 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Must be staff or clinicians (including physicians, nurse practitioners, and physician assistants) in an enrolled primary care practice
  • Primary care practices must be family medicine or general internal medicine practices with a maximum of ten lead clinicians
  • Primary care practices must be either independent or, if part of a larger organization, demonstrate on careful screening that they do not receive significant quality improvement support from the larger organization

Exclusion Criteria:

  • Primary care practices with more than 10 lead clinicians
  • Non-independent primary care practices that receive significant quality improvement support from their system or organization
  • Clinicians and staff who do not speak or read English

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
Comparador activo: Standard practice transformation support
Primary care practices will receive a cardiovascular care toolkit, practice facilitation, practice assessment with feedback, health information technology assistance, academic detailing, and periodic collaborative learning sessions
Experimental: Enhanced practice transformation support
Primary care practices will receive practice facilitation, practice assessment with feedback, health information technology assistance, academic detailing, and periodic collaborative learning sessions PLUS patient advisory council support and a modified cardiovascular care toolkit based on combined practice and patient input regarding the local context.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change of documentation of aspirin therapy in patients with ischemic vascular disease.
Periodo de tiempo: Baseline, 3, 6, 9, 12, and 15 months from baseline
The percent of patients aged 18 years and older with Ischemic Vascular Disease (IVD) with documented use of aspirin or other antithrombotic. This is a practice-level indicator of documentation of care processes for cardiovascular disease.
Baseline, 3, 6, 9, 12, and 15 months from baseline
Change of documentation of blood pressure in patients with a diagnosis of hypertension.
Periodo de tiempo: Baseline, 3, 6, 9, 12, and 15 months from baseline
The percent of patients aged 18 - 85 who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled (<140/90) during the measurement year. This is a practice-level indicator of documentation of care processes for cardiovascular disease.
Baseline, 3, 6, 9, 12, and 15 months from baseline
Change of documentation of blood pressure in patients with adequately controlled blood pressure.
Periodo de tiempo: Baseline, 3, 6, 9, 12, and 15 months from baseline
The percent of patients aged 18 - 85 who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled (age 18-59 and/or people with diabetes or chronic kidney disease <140/90; age 60-85 <150/90) during the measurement year. This is a practice-level indicator of documentation of care processes for cardiovascular disease.
Baseline, 3, 6, 9, 12, and 15 months from baseline
Change of documentation of fasting LDL in patients with a fasting LDL at or below the LDL goal.
Periodo de tiempo: Baseline, 3, 6, 9, 12, and 15 months from baseline
The percent of patients aged 20 - 79 who had a fasting LDL test performed and whose risk-stratified fasting LDL is at or below the recommended LDL goal. This is a practice-level indicator of documentation of care processes for cardiovascular disease.
Baseline, 3, 6, 9, 12, and 15 months from baseline
Change of documentation of patients who had a fasting LDL test performed and prescribed a statin based on risk.
Periodo de tiempo: Baseline, 3, 6, 9, 12, and 15 months from baseline
The percent of patients aged 20 - 79 who had a fasting LDL test performed and who are prescribed a recommended dose of statin based on risk status if indicated. This is a practice-level indicator of documentation of care processes for cardiovascular disease.
Baseline, 3, 6, 9, 12, and 15 months from baseline
Change of documentation of patients screened about tobacco use.
Periodo de tiempo: Baseline, 3, 6, 9, 12, and 15 months from baseline
The percent of patients aged 18 years or older screened about tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. This is a practice-level indicator of documentation of care processes for cardiovascular disease.
Baseline, 3, 6, 9, 12, and 15 months from baseline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change of the documentation in primary care practice's.
Periodo de tiempo: Baseline, 9 and 15 months from baseline
This primary care practice capacity to implement PCOR findings and improve quality and implementation of the planned comprehensive approach. The measure is based on practice-level scores of change process capacity, adaptive reserve, clinician experience and implementation of patient-centered medical home components.
Baseline, 9 and 15 months from baseline

Colaboradores e Investigadores

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

Colaboradores

Investigadores

  • Investigador principal: W. Perry Dickinson, MD, University of Colorado, Denver

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 octubre de 2015

Finalización primaria (Actual)

31 de julio de 2018

Finalización del estudio (Actual)

31 de julio de 2018

Fechas de registro del estudio

Enviado por primera vez

15 de julio de 2015

Primero enviado que cumplió con los criterios de control de calidad

31 de julio de 2015

Publicado por primera vez (Estimar)

5 de agosto de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de enero de 2021

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

22 de enero de 2021

Última verificación

1 de enero de 2021

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 15-0403

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. .

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