Clinical trial NCT04673760: The PROAKTIV Study
Official title: Palliative Needs Assessment and Palliative Care in Primary Care: The PROAKTIV Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Keywords: palliative care
end of life care
home care services
primary care
primary care nursing
outpatient care
quality of healthcare
quality of life
advance care planning
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: University of Bern
First posted: 2020-12-17
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with a new medical indication for specialized palliative home care are assigned to intervention arm.

Patients without a new indication for specialized palliative home care are controls .
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Patients exclusion criteria:

* 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.

Primary outcomes:
measure: Sense of security of patients
timeFrame: From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Secondary outcomes:
measure: Number of patients who define advance directives
timeFrame: From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
measure: Access to advance directives of the patients for the ambulant care providers
timeFrame: From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
measure: Satisfaction with care of patient
timeFrame: From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
measure: Satisfaction with care of GP
timeFrame: From date of baseline measurement of patient to study completion, an average of 6 months, or shorter if patient deceases
Other outcomes:
measure: Health care utilization
timeFrame: From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
measure: Health care costs
timeFrame: From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
measure: Sense of security of family caregivers
timeFrame: From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
measure: Satisfaction with care of family caregivers
timeFrame: From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
measure: Satisfaction with care of home care nurses
timeFrame: From the date of baseline measurement of patient to study completion, an average of 6 months, or shorter if patient deceases
measure: Performance Status of patient
timeFrame: From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
measure: Quality of life of patient
timeFrame: From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
measure: Therapeutic alliance between patients and their home care team
timeFrame: From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Locations:
city: Bern
country: Switzerland
facility: University Hospital Inselspital Bern
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Steffen Eychmüller, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: