Palliative CareNCT04673760
The PROAKTIV Study
A study testing Specialized palliative home care in people with Palliative Care, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palliative Care
- What is being tested?
- Specialized palliative home care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Sep 2020to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
About this study
Official title: Palliative Needs Assessment and Palliative Care in Primary Care: The PROAKTIV Study
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.
Read the 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.
- Conditions
- Palliative Care
- Being tested
- Specialized palliative home care
- Keywords
- palliative care, end of life care, home care services, primary care, primary care nursing, outpatient care, quality of healthcare, quality of life, advance care planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized palliative home careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Structured specialized palliative home care | Experimental | Eligible specialist palliative home care teams provide ambulant specialised palliative care as usual Receives: Behavioral: Specialized palliative home care |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Secondary outcomes (4)
Number of patients who define advance directives
Measured by questionnaire
Measured: 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
Measured: 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"
Measured: 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
Measured: From date of baseline measurement of patient to study completion, an average of 6 months, or shorter if patient deceases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start7 Sep 2020
- Primary completion10 Apr 2022
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, University of Bern
- Responsible party
- Principal investigator, Steffen Eychmüller, Insel Gruppe AG, University Hospital Bern
- Investigators
- Steffen Eychmüller, Prof. dr., Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673760
- Sponsor's protocol ID
- DFL Nr. 4887
- Other IDs
- SNCTP000003820
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2020
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Needs Assessment and Palliative Care in Primary Care: The PROAKTIV Study
- ClinicalTrials.gov ID
- NCT04673760
- Acronym / sponsor ID
- DFL Nr. 4887
- Conditions
- Palliative Care
- Keywords
- palliative care, end of life care, home care services, primary care, primary care nursing, outpatient care, quality of healthcare, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, University of Bern
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 10 Apr 2022 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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 .
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Structured specialized palliative home care | Experimental | Behavioral: Specialized palliative home careEligible specialist palliative home care teams provide ambulant specialised palliative care as usual |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specialized palliative home careSpecialist 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. | Behavioural | Arm 1: Structured specialized palliative home care |
Primary outcome
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.
4 secondary outcomes
Number of patients who define advance directives
Time frame: 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
Time frame: From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Satisfaction with care of patient
Time frame: From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Satisfaction with care of GP
Time frame: From date of baseline measurement of patient to study completion, an average of 6 months, or shorter if patient deceases
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffen Eychmüller, Prof. dr. principal investigator
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specialized palliative home care in people with Palliative Care, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.