The PROAKTIV Study

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Palliative Care

Treatments: Behavioral: Specialized palliative home care

Study type: Interventional

Funder types: Other

Identifiers

NCT04673760

DFL Nr. 4887

SNCTP000003820 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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149 participants in 2 patient groups

Arm 1: Structured specialized palliative home care

Experimental group

Description:

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

Treatment:

Behavioral: Specialized palliative home care

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

No Intervention group

Description:

No care from specialist palliative home care teams at study inclusion