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Understanding the Value of Community Vital Signs in Primary Care

26 de febrero de 2018 actualizado por: Virginia Commonwealth University
Social determinants of health (e.g. the income, education, and environment of patients) may exert greater influence on health outcomes than traditional clinical factors (e.g. lab results, diagnoses, and family history). Calls for integrating primary care and public health are therefore increasing, but merging these domains of care is logistically difficult. Research is lacking on the incremental benefit of adding public health data at the practice level-- in improving either health outcomes or care delivery. This proof of concept pilot will merge data from electronic health records (EHRs) with community vital signs, a set of metrics that describes key community resources that affect health. The investigators will identify resource poor communities, or cold spots, based on four variables (education, poverty, life expectancy, and access to healthy foods) at the census tract level - referred to as a community vital sign. The hypothesis is that patients coming from cold spots are more likely to have worse health outcomes and that clinicians will deliver better care if they know a patient's community context and his/her specific social needs. This study will involve 12 primary care practices in Northern Virginia that care for more than 170,000 patients. Patient addresses will be geocoded for each practice and determine which patients reside in cold spots for each community vital sign. The variation for each community vital sign for each practice's patients will be calculated and a bivariate and regression analyses will be used to determine whether coming from a cold spot is associated with worse clinical quality metrics. 15 clinicians will be alerted when they see a patient from a cold spot, patients will complete a social needs survey, and clinicians will prospectively document through surveys whether such knowledge affects interpersonal interactions (such as time spent with patients and the use of clearer language) or clinical management (such as referrals to care coordination or community resources). By pragmatically integrating community vital signs into care, this innovative proposal will seek to understand which community data clinicians value, how these data might influence care, and how best to incorporate these data into clinical and population care.

Descripción general del estudio

Descripción detallada

The investigators will integrate community vital signs into clinical data, identify cold spots, and determine prospectively how clinicians use these community data at the point of care and for populations of patients. The investigators hypothesize that (1) the patients in a primary care practice live in a range of communities with different social determinants of health, including cold spots that lack health-promoting resources, (2) community vital signs are associated with patient health outcomes (e.g., being up-to-date with preventive care, control of chronic conditions, morbidity), and (3) knowing that a patient resides in a cold spot will help clinicians improve patient care.

Aim 1a: Determine community vital sign cold spots in the catchment area of 12 primary care practices.

Aim 1b: Determine whether patients residing in cold spots experience worse outcomes, such as receiving inadequate care, worse chronic disease control, or higher morbidity.

Aim 2: Determine whether knowing a patient's community vital signs and social needs at the point of care will change clinical management; and explore how practices could use community vital signs for population care.

Aim 3: Identify other community vital signs that practices would find useful for managing patients.

Tipo de estudio

De observación

Inscripción (Actual)

120

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

    • Virginia
      • Fairfax, Virginia, Estados Unidos, 22033
        • Fairfax Family Practice Centers
      • Richmond, Virginia, Estados Unidos, 23298
        • Virginia Ambulatory Care Outcomes Research Network

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 99 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Aims 1a and 1b: The participants include all unique patients seen at the 12 study practices (approximately 170,000 patients over the past two years). Aims 2 and 3: The clinicians in this analysis will include 15 participants recruited from the approximately 100 clinicians at the 12 practices - ideally 1-2 clinicians from each office. Because the study will characterize the upper bounds, or ideal outcomes, in the use of community vital signs, clinicians who are willing to participate and provide feedback will be selectively recruited.

Descripción

Inclusion Criteria:

  • Aims 1a and 1b: Patients seen at one of the 12 study practices
  • Aims 2 and 3: Clinicians at one of the 12 study practices

Exclusion Criteria:

  • Aims 1a and 1b: Patients outside of the age range
  • Aims 2 and 3: Clinicians involved with the design of the research protocol.

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Clinic patients
Aims 1a and 1b: The participants include all unique patients seen at the 12 study practices (approximately 170,000 patients over the past two years).
Clinicians
Aims 2 and 3: The clinicians in this analysis will include 15 participants recruited from the approximately 100 clinicians at the 12 practices
We will present clinicians with information about their patients' communities

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Quality of care
Periodo de tiempo: The past 5 years
Likelihood patient living in a cold spot received recommended cancer screening and cardiovascular preventive care based on National Committee for Quality Assurance (NCQA) quality measures.
The past 5 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
ACG morbidity risk score
Periodo de tiempo: Past 5 years
Likelihood a patient living in a cold spot has a higher Adjusted Clinical Group (ACG) risk score than patient not living in a cold spot.
Past 5 years
Change in care
Periodo de tiempo: Up to one year
Physician report on whether they change care in response to knowing a patient lives in a cold spot.
Up to one year

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Alex Krist, M.D., Virginia Commonwealth University

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 octubre de 2015

Finalización primaria (Actual)

1 de noviembre de 2016

Finalización del estudio (Actual)

1 de noviembre de 2016

Fechas de registro del estudio

Enviado por primera vez

11 de junio de 2015

Primero enviado que cumplió con los criterios de control de calidad

29 de julio de 2015

Publicado por primera vez (Estimar)

31 de julio de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de febrero de 2018

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

26 de febrero de 2018

Última verificación

1 de febrero de 2018

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HM20004050

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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 Cáncer de cuello uterino

Ensayos clínicos sobre Community vital signs

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