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临床试验/NCT04673760
NCT04673760已完成不适用

Palliative Needs Assessment and Palliative Care in Primary Care: The PROAKTIV Study

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2020年9月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
149
试验地点
1
主要终点
Sense of security of patients

研究概览

简要总结

The overall objective of this study is to identify whether the systematic anticipation of highly structured specialized palliative home care into primary care influences the quality of care and care utilization. Quality of care focusses on the sense of security of patients and family caregivers, satisfaction with care of patients, family caregivers, general practitioners, home care nurses and specialized palliative care nurses, and availability and access to advanced directives. Health care utilization focus on the number of hospitalizations and the length of hospital stays.

详细描述

The University Center for Palliative Care from the Inselspital Bern conducts this monocentric mixed-methods controlled study and is responsible for informed consent.

Data consists of questionnaires of patients, their family caregivers, general practitioners, home care nurses and if involved specialized palliative home care nurses. Patients and their family caregivers will fill out baseline questionnaires and follow-up questionnaires at 2, 8, 16 and 24 weeks. Patient follow-up will end if the patient dies or the study ends. Family caregivers will be asked to fill out a questionnaire two months after the patient's death.

General practitioners, home care nurses and specialised palliative home care nurses will fill out questionnaires after the patient's death or at the end of the study. Patient survival data will be collected from administrative health data after the end of the study.

Additionally, a nested qualitative study with semi-structured qualitative interviews with patients, family caregivers and care providers will provide an in-depth understanding of preferences, needs, experiences from this phase of life.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients inclusion criteria:
  • •18 years or older
  • •Able to read and understand German
  • •Able to fill out questionnaires with only minimal assistance
  • •Live in the catchment area of SPHC
  • •Positive screening on the palliative care screening tools
  • •Expected survival time of approximately six months or less
  • •Have a GP (or GP medical substitute)
  • •Registered with Spitex care
  • •Wish to live at home as long as possible (no plans for long term nursing home uptake)
  • •Written informed consent

排除标准

  • •Planned discharged from hospitals to institutions (e.g. other hospitals, rehabilitations, nursing homes)
  • •Live permanently in nursing homes
  • •Cognitive impairments that make it impossible to follow the study (e.g. psychological disorders, dementia, loss of judgement).
  • •Family caregivers inclusion criteria:
  • •18 years or older
  • •Able to read and understand German
  • •Familiar with the care situation patient
  • •Written informed consent
  • •Specialized palliative home care team:
  • •Provide care in German speaking part of canton Bern
  • •24/7-availability of specialized palliative care
  • •Specialized palliative care team including nurses and consulting physician with specialized palliative care certification.

研究组 & 干预措施

Arm 1: Structured specialized palliative home care

Experimental

Eligible specialist palliative home care teams provide ambulant specialised palliative care as usual

干预措施: Specialized palliative home care (Behavioral)

Arm 2: No care of specialist palliative home care teams at study inclusion

No Intervention

No care from specialist palliative home care teams at study inclusion

结局指标

主要结局

Sense of security of patients

时间窗: From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).

Measured by questionnaire Sense of Security in Care - Patients' Evaluation (SEC-P), This questionnaire has 3 subscales namely, the Care Interaction scale; the Identity scale and the Mastery scale. Higher score indicate a higher level of sens of security at home of the patient.

次要结局

  • Satisfaction with care of patient(From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).)
  • Satisfaction with care of GP(From date of baseline measurement of patient to study completion, an average of 6 months, or shorter if patient deceases)
  • Number of patients who define advance directives(From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).)
  • Access to advance directives of the patients for the ambulant care providers(From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steffen Eychmüller

Prof. dr. med.

Insel Gruppe AG, University Hospital Bern

研究点 (1)

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