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Showing Health Information Value in a Community Network

9 de julio de 2014 actualizado por: Duke University
The purpose of this study is to determine the value of shared health information on care quality and costs when this information is used to notify care providers about concerning health events for patients cared for by a community-based network of providers.

Descripción general del estudio

Descripción detallada

Project Abstract This three-year project will assess the costs and benefits of health information technology (HIT) in an established community-wide network of academic, private and public healthcare facilities created to share clinical information for the purpose of population-based care management of over 16,000 Medicaid beneficiaries in Durham County, North Carolina. The area of interest for this project is the impact of information-driven interventions on care quality, patient safety and healthcare costs across the diverse stakeholders participating in this collaborative partnership. In order to asses HIT value rigorously in the context of a production information system that is under continual development, we propose to conduct a randomized controlled trial. Specifically, we will randomly assign patients by family unit to either a control group or to an intervention group in which they will initially receive one of 3 information-driven interventions. The interventions include clinical alerts sent to care providers, performance feedback reports presented to clinic managers, and care reminders sent directly to patients. The content of the interventions will address "concerning" events (e.g., an emergency room encounter for asthma) and care deficiencies (e.g., delinquency on biannual mammogram) identified from the composite set of clinical data in our information system. To assess the benefits and burdens of the interventions, combinations of the 3 interventions will be sequentially introduced into the study groups over the course of the project. The analysis will compare groups receiving various combinations of interventions as well as those receiving no interventions. At baseline and at six-month intervals throughout the course of the study, we will measure emergency department encounter rates, hospitalization rates, HEDIS (Healthcare Effectiveness Data and Information Set) scores, missed appointment rates, glycated hemoglobin levels in diabetics, and patient satisfaction. Our assessment will look at the societal value of HIT as well as the value for individual stakeholders including patients, providers, payers, purchasers and policy makers. From these measures, we will assess the costs and benefits of this community-wide effort to promote interoperability of clinical data exchange in order to increase the understanding of HIT value in a community setting. In our preliminary studies, we have observed a statistically significant 3-fold reduction in repeat ED (Emergency Department) encounter rates using email alerts alone. The approach used in this project is able to be generalized across geographic areas and healthcare settings and can, therefore, serve to promote the dissemination of HIT to other communities.

Tipo de estudio

Intervencionista

Inscripción (Actual)

20108

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

    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
        • Duke University Medical Center

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

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Enrollment in the Community Care of North Carolina Medicaid program in Durham County North Carolina

Exclusion Criteria:

-

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 1
electronic mail notifications to care managers about sentinel health events
computer decision support system that generates notifications about sentinel health events and communicates this information via electronic mail to care managers, feedback reports to clinical managers, and letters to patients
Otros nombres:
  • Decision support engine is called SEBASTIAN
Experimental: 2
feedback reports with notifications to clinic managers about sentinel health events
computer decision support system that generates notifications about sentinel health events and communicates this information via electronic mail to care managers, feedback reports to clinical managers, and letters to patients
Otros nombres:
  • Decision support engine is called SEBASTIAN
Experimental: 3
letters to patients with notifications about sentinel health events
computer decision support system that generates notifications about sentinel health events and communicates this information via electronic mail to care managers, feedback reports to clinical managers, and letters to patients
Otros nombres:
  • Decision support engine is called SEBASTIAN
Sin intervención: 4
electronic mail notifications to care managers about sentinel health events -- generated but withheld
Sin intervención: 5
feedback reports with notifications to clinic managers about sentinel health events -- generated but withheld
Sin intervención: 6
letters to patients with notifications about sentinel health events -- generated but withheld

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Emergency department utilization rates and hospitalization rates
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
ED encounter rates for low severity conditions
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
ED encounter rates for asthma
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
ED encounter rates for diabetes
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Hospitalization rates
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Hospitalization rates for asthma (also PQI)
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Hospitalization rates for diabetes (also PQI)
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Glycemic control (hemoglobin A1c)
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Medication contraindications
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
HEDIS - Preventive services
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
HEDIS - # WCC visits
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
AHRQ Prevention Quality Indicators
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
HEDIS - Asthma and diabetes
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
# of messages triggered for health risks
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
# of messages triggered for barriers to care
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Missed appointment rates
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Primary care appointment rates
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
F/U rates post-partum
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Patient satisfaction instruments (CHAPS)
Periodo de tiempo: at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
EuroQoL
Periodo de tiempo: at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
Provider opinion surveys
Periodo de tiempo: At conclusion of study
At conclusion of study
Costs of ED utilization for all causes
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Costs of ED use for asthma
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Costs of ED use for diabetes
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Costs of ED use for low severity visits
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Hospitalization costs for all causes
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Hospitalization costs for asthma
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Hospitalization costs for diabetes
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Reimbursement for labs+other ancillary services
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Primary care reimbursement
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
ED rates for recurrent ED encounters
Periodo de tiempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: David F Lobach, MD, PhD, Duke University

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 agosto de 2006

Finalización primaria (Actual)

1 de julio de 2008

Finalización del estudio (Actual)

1 de agosto de 2008

Fechas de registro del estudio

Enviado por primera vez

16 de agosto de 2006

Primero enviado que cumplió con los criterios de control de calidad

16 de agosto de 2006

Publicado por primera vez (Estimar)

18 de agosto de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

11 de julio de 2014

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

9 de julio de 2014

Última verificación

1 de diciembre de 2012

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Pro00006833
  • R01HS015057 (Subvención/Contrato de la AHRQ de EE. UU.)

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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