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| ID | Type | Description | Link |
|---|---|---|---|
| SNCTP000003820 | Registry Identifier | Swiss National Clinical Trials Portal |
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| Name | Class |
|---|---|
| Swiss National Science Foundation | OTHER |
| University of Bern | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Structured specialized palliative home care | Experimental | Eligible specialist palliative home care teams provide ambulant specialised palliative care as usual |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specialized palliative home care | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sense of security of patients | 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. | From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who define advance directives | Measured by questionnaire | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Health care utilization | Measured by questionnaire | From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively). |
| Health care costs |
Patients inclusion criteria:
Patients exclusion criteria:
Family caregivers inclusion criteria:
Specialized palliative home care team:
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| Name | Affiliation | Role |
|---|---|---|
| Steffen Eychmüller, Prof. dr. | Insel Gruppe AG, University Hospital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Inselspital Bern | Bern | Switzerland |
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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 .
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Measured by questionnaire |
| From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively). |
| Satisfaction with care of patient | Measured by questionnaire Modified FAMCARE Scale P16. 16 Questions on care with answers (Likert-type scale 1 to 5) ranging from "very satisfied with care" to "very dissatisfied with care" | From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively). |
| Satisfaction with care of GP | Measured by questionnaire | From date of baseline measurement of patient to study completion, an average of 6 months, or shorter if patient deceases |
Measured by administrative health care data
| From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively). |
| Sense of security of family caregivers | Measured by questionnaire | From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively). |
| Satisfaction with care of family caregivers | Measured by questionnaire FAMCARE-2 Scale. 17 questions on care with answers ( Likert-type scale 1 to 5) ranging from "very satisfied with care" to "very dissatisfied with care". | From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively). |
| Satisfaction with care of home care nurses | Measured by questionnaire | From the date of baseline measurement of patient to study completion, an average of 6 months, or shorter if patient deceases |
| Performance Status of patient | Measured by questionnaire , ECOG Scale of performance status.Grading 1 to 4 and higher score indicates lower performance status. | From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively). |
| Quality of life of patient | Measured by questionnaire Functional Assessment of Chronic Illness Therapy - Palliative Care 14 Item Version (FACIT-Pal-14). (5 point Likert-type scale) | From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively). |
| Therapeutic alliance between patients and their home care team | Measured by questionnaire The Human Connection Scale (THC) measures the extent to which patients felt a sense of mutual understanding, caring, and trust with their GP, (specialized palliative) home care nurses ( Likert-type scale 1 to 5) | From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively). |