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Inter-rater Reliability of the Clinical Frailty Scale in a Swedish Emergency Department Setting

12 de noviembre de 2021 actualizado por: Daniel Wilhelms, University Hospital, Linkoeping

Frailty is a common clinical syndrome in older adults, which may be assessed through various assessment tools. One frequently used tool is the Clinical Frailty Scale (CFS) which potentially can be adopted for daily use in the Emergency Department and has been appraised for reliability to some extent, but have so far not been evaluated in the Swedish emergency care context.

The purpose of this study is to evaluate the inter-rater reliability of the Clinical Frailty Scale (CFS) in a clinical Swedish Emergency Department (ED) setting. Members of multidisciplinary emergency care teams will conduct the assessments individually.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

The CFS is introduced and tested as part of a quality-improvement process regarding elderly people within the Emergency departments (EDs) of Region Östergötland (Östergötland County) in Sweden.

CFS is a 9-point scale developed within the Canadian Study of Health and Aging. It comprises of a pictograms and a clinical description to help assign scores ranging from very fit to terminally ill. CFS enables clinicians to rapidly stratify the degree of frailty in the elderly with the help of questions and clinical assessment. However, since the assessment is judgement based, it is important that the inter-rater reliability is satisfactory.

This study is part of a larger project where all eligible patients who visit the ED (24/7) for a period of four weeks will be enrolled and then subsequently assessed with CFS by one of their responsible health-care professionals (i.e. physician, registered nurse or nurse assistant). For this study, each professional on the team will individually assess each patient. First, a clinical judgement is performed (frail/not frail) without any instrument, and then the patient is assessed by using the CFS. This will take place during work shifts when someone from the research team is present and can arrange the assessments, as well as ensure that they are conducted independently. These work shifts will be selected using the online application Research Randomizer, to randomly include all hours of the day as well as eligible health-care professionals.

The research-team member will collect the assigned CFS-scores and information on the age, gender, profession, position (emergency physician or intern/resident from other specialities) and the number of years in the profession of each assessor. Informed consent will be obtained from all health-care professionals who participate. No data that can identify any patient will be collected.

Sample size is determined to be 100 patients, which would be more than sufficient with a power of 90% and α 0,05.

Tipo de estudio

De observación

Inscripción (Actual)

100

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

    • Östergötland
      • Linköping, Östergötland, Suecia, 58185
        • Akutmottagningen US Östergötland

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

65 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Health care professionals:

Physicians, nurses and assistant nurses who are the responsible healthcare professionals for the enrolled patients

Patients:

Patients of all genders at the age of ≥65 years seeking medical care at the three ED instances in Region Östergötland.

Descripción

Inclusion Criteria:

Health-care professionals:

- Working in the ED, as part of the emergency-care team that are responsible for a patient ≥65 years

Patients:

- ≥65 years

Exclusion Criteria:

Health care professionals:

- Unwilling to provide informed consent

Patients:

- ≤65 years

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Level of inter-rater reliability regarding frailty as assessed by CFS
Periodo de tiempo: The assessment will be made in connection with the patient´s first meeting with the care team, i.e. within 1 hour from the patient´s arrival to the ED
Inter-rater reliability of the CFS, expressed as Intraclass Correlation Coefficient
The assessment will be made in connection with the patient´s first meeting with the care team, i.e. within 1 hour from the patient´s arrival to the ED

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Level of correlation between degree of frailty (CFS 1-9) and degree of inter-rater reliability
Periodo de tiempo: The assessment will be made in connection with the patient´s first meeting with the care team, i.e. within 1 hour from the patient´s arrival to the ED
Investigates whether inter-rater reliability, expressed as Intraclass Correlation Coefficient, varies between scale scores in CFS. Described descriptively.
The assessment will be made in connection with the patient´s first meeting with the care team, i.e. within 1 hour from the patient´s arrival to the ED
Agreement between CFS and clinical judgement (frail/not frail)
Periodo de tiempo: The clinical judgement is made just before the assessment with CFS
Investigates the agreement between a clinical judgement (with no frailty tool) regarding the patient being frail or not, compared to frailty according to the CFS (cut-off 5). Expressed as a percentage.
The clinical judgement is made just before the assessment with CFS

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Difference in measures for Inter-rater reliability, expressed as Intraclass Correlation Coefficient, between care teams with emergency physicians in relation to care teams with interns/residents from other specialties.
Periodo de tiempo: The assessment will be made in connection with the patient´s first meeting with the care team, i.e. within 1 hour from the patient´s arrival to the ED
An Emergency department in Sweden typically has physicians from other specialities who work for a period of time. They may not have the same education and training in CFS assessments, we want to explore if the results differ in terms of inter-rater reliability between care teams with emergency physicians and care teams with other physicians.
The assessment will be made in connection with the patient´s first meeting with the care team, i.e. within 1 hour from the patient´s arrival to the ED

Colaboradores e Investigadores

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

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.

Publicaciones Generales

Enlaces Útiles

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)

3 de mayo de 2021

Finalización primaria (Actual)

31 de octubre de 2021

Finalización del estudio (Actual)

31 de octubre de 2021

Fechas de registro del estudio

Enviado por primera vez

26 de abril de 2021

Primero enviado que cumplió con los criterios de control de calidad

29 de abril de 2021

Publicado por primera vez (Actual)

3 de mayo de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de noviembre de 2021

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

12 de noviembre de 2021

Última verificación

1 de noviembre de 2021

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

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. .

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