The PROAKTIV Study

Study Overview
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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.

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

Conditions
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Palliative Care

Intervention / Treatment
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* Behavioral: Specialized palliative home care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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 .
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Structured specialized palliative home care<br>Eligible specialist palliative home care teams provide ambulant specialised palliative care as usual | Behavioral: Specialized palliative home care<br>* 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.<br>|
| No Intervention: Arm 2: No care of specialist palliative home care teams at study inclusion<br>No care from specialist palliative home care teams at study inclusion | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advance care planning, palliative care, end of life care, home care services, primary care, primary care nursing, outpatient care, quality of healthcare, quality of life