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Study Evaluating the Effect of Person-centred Care for Patients Admitted for Inpatient Care at an Internal Medicine Unit

29 de octubre de 2018 actualizado por: Göteborg University

Person-centred Inpatient Care - a Quasi-experimental Study Within an Internal Medicine Context

Patients admitted to internal medicine care environments have complex care needs and must be treated as persons with resources and responsibilities. Person-centred care is defined as care in which the caregiver aims to get to know the patient as a person, and the care comprises a holistic approach to assess patients' needs and resources. There is strong motivation for future health care to transform into an approach that acknowledges and endorses every patient's resources, interests and needs. There is limited existing research on the benefit of implementing person-centred care in internal medicine care environments for all patients regardless of diagnosis or care pathway. Little is known about the effects of person-centred inpatient care on patients' satisfaction with care. This study includes adult patients admitted to an internal medicine inpatient unit regardless of reason for admission. The aim of the study is to evaluate effects of person-centred inpatient care on care processes, in terms of satisfaction with care and person-centred content in medical records and to evaluate effects on self-reported health and self-efficacy.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

177

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

  • Suecia
      • Gothenburg, Suecia, 41345
        • Department of Medicine, Sahlgrenska University Hospital

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:

  • acute or elective admission with a minimum projected in-hospital stay of 24 hours
  • age ≥ 18 years
  • conscious and alert, with no delay in response.

Exclusion Criteria:

  • cognitive impairment or a judgment by the caregivers that inclusion was not in the best interests of the patient (e.g. end of life care, impaired psychological wellbeing).

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Person-centred inpatient care
Otro: Person-centred inpatient care

The intervention comprises three sequential steps in the care process. The first two steps follow one after the other in conjunction with admission to the ward: 1) person-centred assessment, and 2) creation of a person-centred health plan. Persistent person-centred inpatient care, the third step, is practiced throughout the hospital stay, and is a component of the quality and patient safety program.

The model is systematically applied to all patients admitted to the unit. All staff are trained in PCC before implementation of the intervention.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Satisfaction with care comprise patients' evaluations of caregivers' identity-oriented approach and the sociocultural atmosphere at the ward.
Periodo de tiempo: From date of admission until the date of discharge, up to 60 days of hospitalization.
The outcome is assessed with the questionnaire Quality from the Patient Perspective. The questionnaire comprises four dimension of with two dimensions is used: Identity-oriented approach (13 items) and the sociocultural atmosphere (5 items). One item from the medical competence subscale (effective pain relief) and one additional item on provision of information about medications is also used. Two kinds of assessments are being made at each item: whether things were being done (perceived reality) and whether the right things were being done (subjective significance). For the primary outcome only the assessments of perceived reality are being used. Items are rated on a four-point response scale ranging from 1 (do not agree at all) to 4 (completely agree). Each item also has a response option of "not applicable". Subscales can be reported item by item or combined in a subscale score (average of all responses within the subscale).
From date of admission until the date of discharge, up to 60 days of hospitalization.
Person-centred content in medical records
Periodo de tiempo: From date of admission until the date of discharge, up to 60 days of hospitalization.
Degree of person-centredness in medical records
From date of admission until the date of discharge, up to 60 days of hospitalization.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Self-reported health assessed with EQ-5D-5L
Periodo de tiempo: at the date of discharge, an average of 5 days after inclusion
Self-reported health is measured with the EuroQual-5Dimensions-5Levels questionnaire (EQ- 5D- 5L). The questionnaire comprises 1 item per dimension. The dimensions of importance for health which are included are; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Patients rate each item on a scale ranging from 1 (no problems) to 5 (extreme problems/unable to). A unique health state is defined by combining 1 level from each of the 5 dimensions. The questionnaire also includes EQ-VAS, in which the patients grade their current health status on an analogue scale from 0 (worst health) to 100 (best health).
at the date of discharge, an average of 5 days after inclusion
Physical and psychological wellbeing assessed with the Quality from the Patient Perspective questionnaire
Periodo de tiempo: at the date of discharge, an average of 5 days after inclusion
Patients rated their physical and psychological wellbeing on two separate five-point Likert scales ranging from "very good" (5) to "very bad" (1). These two items are included in the Quality from the Patient Perspective questionnaire as two separate questions.
at the date of discharge, an average of 5 days after inclusion
Level of general self-efficacy assessed with the General Self-Efficacy scale
Periodo de tiempo: at the date of discharge, an average of 5 days after inclusion
General self-efficacy measures confidence in one's ability to handle difficult challenges in life. It includes 10 items, which are rated on a four- point Likert scale giving a summary score of 40 for the total scale (10-40).
at the date of discharge, an average of 5 days after inclusion
Quality of care measured with ratings of Medical-technical competence and physical conditions at the ward assessed with the questionnaire Quality from the Patient Perspective.
Periodo de tiempo: From date of admission until the date of discharge, up to 60 days of hospitalization.
The questionnaire comprises four dimension of with the two rational dimensions was used for this specific aim: medical- technical competence (4 items) and physical-technical condition (3 items). Two kinds of assessments are being made at each item: whether things were being done (perceived reality) and whether the right things were being done (subjective significance). For this secondary outcome the assessments of perceived reality is being used. A four-point response scale ranging from 1 (do not agree at all) to 4 (completely agree) forms the basis of ratings, each item also had a response option of "not applicable". Subscales can be reported item by item or combined in a subscale score (average of all responses within the subscale).
From date of admission until the date of discharge, up to 60 days of hospitalization.
Clinical observations of pulse rate
Periodo de tiempo: From date of admission until the date of discharge, up to 60 days of hospitalization.
Frequency of documented pulse rate during hospitalization. The medical records are reviewed retrospectively.
From date of admission until the date of discharge, up to 60 days of hospitalization.
Quality of care assessed as documented information in medical records on current medication at a daily basis and at discharge
Periodo de tiempo: From date of admission until the date of the discharge, up to 60 days of hospitalization.
All information in the medical records during hospitalization are reviewed retrospectively. Rating is made regarding the presence (yes or no) of information on current medication at a daily basis and at discharge.
From date of admission until the date of the discharge, up to 60 days of hospitalization.
Quality of care assessed as documented information in medical records on planned medical care at discharge.
Periodo de tiempo: From date of admission until the date of discharge, up to 60 days of hospitalization.
All information in the medical records during hospitalization are reviewed retrospectively. Rating is made regarding the presence (yes or no) of information on planned medical care at discharge.
From date of admission until the date of discharge, up to 60 days of hospitalization.
Clinical observations of weight
Periodo de tiempo: From date of admission until date of discharge, up to 60 days of hospitalization.
Frequency of documented clinical observations of weight (kg) during hospitalization. The medical records are reviewed retrospectively.
From date of admission until date of discharge, up to 60 days of hospitalization.
Clinical observations of blood pressure
Periodo de tiempo: From date of admission until the date of discharge, up to 60 days of hospitalization.
Frequency of documented clinical observations of systolic and diastolic blood pressure during hospitalization. The medical records are reviewed retrospectively.
From date of admission until the date of discharge, up to 60 days of hospitalization.
Clinical observations of respiratory rate
Periodo de tiempo: From date of admission until the date of discharge, up to 60 days of hospitalization.
Frequency of documented clinical observations of respiratory rate during hospitalization. The medical records are reviewed retrospectively.
From date of admission until the date of discharge, up to 60 days of hospitalization.
Body temperature
Periodo de tiempo: From date of admission until the date of discharge, up to 60 days of hospitalization.
Frequency of documented clinical observations of body temperature (degrees celsius) during hospitalization. The medical records are reviewed retrospectively.
From date of admission until the date of discharge, up to 60 days of hospitalization.

Colaboradores e Investigadores

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

Patrocinador

Göteborg University

Investigadores

  • Investigador principal: Eva Jakobsson Ung, Associate professor, Department of Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden and Institute of Health and Care Sciences, Sahlgrenska Academy at the University of Gothenburg

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)

9 de noviembre de 2015

Finalización primaria (Actual)

30 de junio de 2016

Finalización del estudio (Actual)

30 de junio de 2016

Fechas de registro del estudio

Enviado por primera vez

16 de octubre de 2018

Primero enviado que cumplió con los criterios de control de calidad

29 de octubre de 2018

Publicado por primera vez (Actual)

31 de octubre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

31 de octubre de 2018

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

29 de octubre de 2018

Última verificación

1 de octubre de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Person-centred care

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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