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Prediction of Hospital Readmissions in SAPV (Specialised Home Palliative Care) Patients (PRePP)

10 de agosto de 2022 atualizado por: Technische Universität Dresden

Prediction of Hospital Readmissions in SAPV (Specialised Home Palliative Care) Patients - Identification of Structural Factors and Support Needs of Family Caregivers

Specialised outpatient palliative care (German: Spezialisierte ambulante Palliativversorgung, abbreviation: SAPV) aims to support incurably ill or dying people spending their last lifetime at home. Furthermore, a major goal is to prevent unnecessary hospital admissions. However, they occasionally occur for various reasons. This project aims to explore predictors of readmission in terms of structural factors as well as family caregivers' psychological distress.

Study Aims

  1. Identification of structural predictors and caregiver reported predictors for hospital readmissions.
  2. Identification of psychological liabilities of nursing relatives.
  3. Developing a concept to support nursing relatives.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

  1. Background Specialised outpatient palliative care (German: Spezialisierte ambulante Palliativversorgung, abbreviation: SAPV) aims to support incurably ill or dying people spending their last lifetime at home if possible.

    At the same time unnecessary hospital readmissions should be prevented. However, they occasionally occur for various reasons. Due to an analysis of own data including 81 patient of our institution we found the following structural factors influencing hospital readmissions: On average there are 1.3 hospital admissions per patient while receiving palliative care. The quality of home-based care is one factor for hospital readmission. Especially patients´ high symptom burden as well as caregivers´ report of depression and anxiety lead to unplanned hospital readmissions.

    Former studies show a major impact of psychosocial pressure of relatives, for example sadness, sorrows, and exhaustion). High scores of distresses seem to correlate with a higher number of unfulfilled needs. About one third of the nursing relatives reached high scores concerning anxiety and depression. Moreover, an elevated level of resilience relates to a positive opinion of health, better social support, and a decreased rate of depressions of patients who suffer from metastasised oncological diseases. Life quality of nursing relatives is not only decreased in a psychological way but in all parts of life and is influenced by spiritual well-being and by the relation of the patient and the nursing person. The relevance of stable relationship between familiar and professional helpers is also described by Roen and his colleagues.

  2. Methods This study is designed as a single-arm, single institution, non-randomized observational study.

The primary study aim is to investigate structural, and caregiver reported reasons for hospital readmission. Burden and needs for support of informal caregivers that lead to a failure of ambulatory care should be identified. Afterwards experts will develop strategies to improve the identified factors and therefore reduce the number of unnecessary hospital readmissions.

2.1 Primary goal Are there any structural or caregiver reported factors influencing hospital readmission during concomitant care by SAPV?

2.2 Secondary goals To explore the burden and supportive-care needs experience informal caregivers caring for patients with an incurable and progressive disease at home? Which concepts can be developed to improve pressures and needs for support of nonprofessional caregivers during the patients´ palliative care?

2.3 Patients This study aims to include consecutively 240 patients of our institution's specialized outpatient palliative care team.

2.4 Primary and Secondary endpoints Primary outcome is the number of unplanned admissions. An unplanned admission is defined as any hospital stay not being previously planned as part of intended treatment.

Secondary endpoints include structural data taken from the patients´ medical records. Furthermore, four validated questionnaires will be administered to obtain family caregiver reported factors:

  • quality of life (WHOQOL BREF (WHO | WHO Quality of Life-BREF (WHOQOL-BREF), n.d.)
  • psychological distress (NCCN Distress Thermometer)
  • anxiety (Generalized Anxiety Disorder 7-item scale)
  • depression (Health Questionnaire depression module 9- item scale).

In addition, a non-standardized questionnaire identifying the burden of relatives caused by the SARS-CoV-2-pandemia is administered.

The following structural data concerning the informal caregiver will be evaluated: age, sex, relationship to the patient, amount of care, educational background, and actual working situation.

The following structural data concerning the patient will be registered: age, sex, diagnosis justifying imbursement of palliative care, duration of palliative care, hospital admissions during SAPV, support by informal caregivers, level of care, use of home-based services, home hospice, reason for hospital admissions, concomitant cancer therapy, data concerning the hospital admission, place of discharge. Information will be collected from the patients´ medical records.

Nurses of SAPV will answer surprise questions monthly: There will be one surprise question concerning patients´ death and another one concerning the probability of hospital readmission.

Tipo de estudo

Observacional

Inscrição (Real)

240

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

    • Saxony
      • Dresden, Saxony, Alemanha, 01307
        • University Hospital Carl Gustav Carus

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

Sim

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

All patients treated in SAPV University hospital Dresden will be investigated by descriptive statistics. All respective non-professional-caregivers will be asked to take part in the survey. They must meet the aforementioned inclusion criteria and provide informed consent.

Descrição

Inclusion Criteria:

  • adult patients (>17years)
  • with advanced, non-curable disease with limited life expectancy and complex symptoms
  • treated by a Specialised Home Palliative Care - team
  • providing informed consent

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Circumstances of Unplanned hospital admission
Prazo: 18 months
Hospital admission not intended and/or planned by either professional nor non-professional care givers
18 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Quality of Life of primary non-professional care-giver
Prazo: 18 months
Quality of Life as assessed by WHOQOL-BREF (World Health Organization Quality of Life)
18 months
Psychological Distress of primary non-professional care-giver
Prazo: 18 months
Psychological Distress as assessed by NCCN-Distress Thermometer
18 months
Anxiety of primary non-professional care-giver
Prazo: 18 months
Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
18 months
Depressivity of primary non-professional care-giver
Prazo: 18 months
Depressivity as assessed by the Health Questionnaire depression module 9-item scale
18 months
Characteristics of the non-professional care-giver
Prazo: 18 months
Characteristics of primary non-professional care giver such as age, gender, kind of relation to the patient, duration of daily care, highest education, employment status
18 months
Characteristics of patient
Prazo: 18 months
Characteristics of patient such as age, gender, diagnosis, duration of previous hospitalisation, additional supportive services, number of visits by SAPV, symptoms status,
18 months

Colaboradores e Investigadores

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

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Katharina Schütte, MD, University Hospital Dresden; Palliative Care Unit
  • Investigador principal: Leopold Hentschel, Dipl.-Psych., University Hospital Dresden; Department of Psychooncology

Publicações e links úteis

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Publicações Gerais

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)

12 de abril de 2021

Conclusão Primária (Real)

30 de junho de 2022

Conclusão do estudo (Real)

30 de julho de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

4 de maio de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de outubro de 2021

Primeira postagem (Real)

19 de outubro de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de agosto de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de agosto de 2022

Última verificação

1 de agosto de 2022

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • BO-EK-320072020

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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