Palliative Needs Assessment and Palliative Care in Primary Care: The PROAKTIV Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 149
- Locations
- 1
- Primary Endpoint
- Sense of security of patients
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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
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.
Arms & Interventions
Arm 1: Structured specialized palliative home care
Eligible specialist palliative home care teams provide ambulant specialised palliative care as usual
Intervention: Specialized palliative home care (Behavioral)
Arm 2: No care of specialist palliative home care teams at study inclusion
No care from specialist palliative home care teams at study inclusion
Outcomes
Primary Outcomes
Sense of security of patients
Time Frame: From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
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.
Secondary Outcomes
- Satisfaction with care of patient(From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).)
- Satisfaction with care of GP(From date of baseline measurement of patient to study completion, an average of 6 months, or shorter if patient deceases)
- Number of patients who define advance directives(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(From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).)
Investigators
Steffen Eychmüller
Prof. dr. med.
Insel Gruppe AG, University Hospital Bern