The PROAKTIV Study

NCT ID: NCT04673760

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-07

Study Completion Date

2023-08-01

Brief Summary

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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

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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.

Conditions

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Palliative Care

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm 1: Structured specialized palliative home care

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

Group Type EXPERIMENTAL

Specialized palliative home care

Intervention Type BEHAVIORAL

Specialist palliative home care teams will initiate care as usual, including managing a systematic and collaborative process of advance care planning with patients, family caregivers, GPs and SPITEX nurses using the "Betreuungsplan", information packages and regular case meetings. The GP was additionally provided with educational palliative care information by the study team.

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

No care from specialist palliative home care teams at study inclusion

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Specialized palliative home care

Specialist palliative home care teams will initiate care as usual, including managing a systematic and collaborative process of advance care planning with patients, family caregivers, GPs and SPITEX nurses using the "Betreuungsplan", information packages and regular case meetings. The GP was additionally provided with educational palliative care information by the study team.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* 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.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss National Science Foundation

OTHER

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Steffen Eychmüller

Prof. dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steffen Eychmüller, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

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University Hospital Inselspital Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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SNCTP000003820

Identifier Type: REGISTRY

Identifier Source: secondary_id

DFL Nr. 4887

Identifier Type: -

Identifier Source: org_study_id