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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 outubro de 2018 atualizado 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.

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Real)

177

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Satisfaction with care comprise patients' evaluations of caregivers' identity-oriented approach and the sociocultural atmosphere at the ward.
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Self-reported health assessed with EQ-5D-5L
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

9 de novembro de 2015

Conclusão Primária (Real)

30 de junho de 2016

Conclusão do estudo (Real)

30 de junho de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

16 de outubro de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de outubro de 2018

Primeira postagem (Real)

31 de outubro de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

31 de outubro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de outubro de 2018

Última verificação

1 de outubro de 2018

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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