Palliative Carepro-SpinozaNCT02266069
PROject - Supportive and Palliative Care and INnOvation - Antwerp (Pro-Spinoza)
A study testing Care Pathway for Primary Palliative Care in people with Palliative Care and Primary Health Care, run by Bert Leysen at 4 sites in Belgium.
Trial summary
It is important to provide high quality palliative care to all patients with a non-curable and life-limiting condition. The Care Pathway for Primary Palliative Care (CPPPC) provides tools for health care professionals to help them delivering palliative care timely and accurately.This study investigates whether the… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Palliative Care, Primary Health Care
- What is being tested?
- Care Pathway for Primary Palliative Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 4 sitesBelgium
- Study dates
- Oct 2014to Dec 2016
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- identified as a palliative care patient using the Surprise Question "Would you, as a family doctor, be surprised if this patient would die in the next 12 months?". If the answer is 'no', the patient is eligible for the study.
Who cannot join
- not having signed the informed consent.
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
Palliatieve Hulpverlening Antwerpen
Antwerp
Palliabru
Brussels-Capital Region
Netwerk Palliatieve Zorg Limburg
Hasselt, Limburg
Reliance
Mons, Hainaut
About this study
Official title: Implementation of the Care Pathway for Primary Palliative Care in Five Research Clusters in Belgium
It is important to provide high quality palliative care to all patients with a non-curable and life-limiting condition. The Care Pathway for Primary Palliative Care (CPPPC) provides tools for health care professionals to help them delivering palliative care timely and accurately.This study investigates whether the implementation of the CPPPC really helps to improve patients' lifes.
- Conditions
- Palliative Care, Primary Health Care
- Being tested
- Care Pathway for Primary Palliative Care
- Keywords
- implementation, anticipatory care planning, symptom assessment, interdisciplinary collaboration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Pathway for Primary Palliative CareOther
Also called CPPPC
Early identification of palliative care patients, anticipatory care planning, systematic symptom assessment, interdisciplinary collaboration, rigorous follow-up of the functional status of the patient and giving attention to the informal care givers.
| Study group | Role | What they receive |
|---|---|---|
| Research cluster 1: Antwerp | Other | The first Dutch-speaking research cluster in a stepped wedge cluster design. Family doctors are implementing the Care Pathway for Primary Palliative Care and will recruit eligible patients from October 2014. Receives: Other: Care Pathway for Primary Palliative Care |
| Research cluster 2: Mons | Other | The first French-speaking research cluster in a stepped wedge cluster design. Family doctors are implementing the Care Pathway for Primary Palliative Care and will recruit eligible patients from November 2014. Receives: Other: Care Pathway for Primary Palliative Care |
| Research cluster 3: Brussels | Other | The only bilingual Dutch/French-speaking research cluster in a stepped wedge cluster design. Family doctors are implementing the Care Pathway for Primary Palliative Care and will recruit eligible patients from December 2014. Receives: Other: Care Pathway for Primary Palliative Care |
| Research cluster 4: Limburg | Other | The second Dutch-speaking research cluster in a stepped wedge cluster design. Family doctors will implement the Care Pathway for Primary Palliative Care and will recruit eligible patients from April 2015. Receives: Other: Care Pathway for Primary Palliative Care |
| Research cluster 5: ? | Other | A second French-speaking research cluster in a stepped wedge cluster design. Family doctors will implement the Care Pathway for Primary Palliative Care and will recruit eligible patients from October 2015. Receives: Other: Care Pathway for Primary Palliative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of deaths occurred in the hospital (of patients per family doctor/per research cluster)
The hypothesis is that the CPPPC reduces the percentage of deaths occurred in the hospital
Measured: 6 months
Secondary outcomes (4)
cost of health care consumption in the last year of life (of patients per family doctor/per research cluster)
The hypothesis is that the CPPPC reduces the cost of health care consumption in the last year of life
Measured: 6 months
consumption of antibiotics in the last year of life (of patients per family doctor/per research cluster)
The hypothesis is that the CPPPC reduces the consumption of antibiotics in the last year of life
Measured: 6 months
consumption of pain killers in the last year of life (of patients per family doctor/per research cluster)
The hypothesis is that the CPPPC augments the consumption of pain killers in the last year of life
Measured: 6 months
consumption of (invasive) diagnostic and therapeutic procedures in the last year of life (of patients per family doctor/per research cluster)
The hypothesis is that the CPPPC reduces the consumption of (invasive) diagnostic and therapeutic procedures in the last year of life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bert Leysen
- Sponsor type
- University, hospital or other
- Collaborators
- Intermutualistic Agency, National Institute for Health and Disability Insurance, Belgium
- Responsible party
- Sponsor-investigator, Bert Leysen, Universiteit Antwerpen
- Investigators
- Bart Van den Eynden, MD, PhD, Principal investigator, Universiteit AntwerpenJohan Wens, MD, PhD, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266069
- Sponsor's protocol ID
- UA C130298
- Acronym
- pro-Spinoza
- Status last verified
- Nov 2017
- First submitted
- 10 Oct 2014
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Leysen B, Van den Eynden B, Janssens A, Wens J. Recruiting general practitioners for palliative care research in primary care: real-life barriers explained. BMC Fam Pract. 2019 Mar 5;20(1):40. doi: 10.1186/s12875-019-0930-y.
PubMed 30836994Leysen B, Van den Eynden B, Gielen B, Bastiaens H, Wens J. Implementation of a Care Pathway for Primary Palliative Care in 5 research clusters in Belgium: quasi-experimental study protocol and innovations in data collection (pro-SPINOZA). BMC Palliat Care. 2015 Sep 28;14:46. doi: 10.1186/s12904-015-0043-x.
PubMed 26416574
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Care Pathway for Primary Palliative Care in Five Research Clusters in Belgium
- ClinicalTrials.gov ID
- NCT02266069
- Acronym / sponsor ID
- pro-Spinoza / UA C130298
- Conditions
- Palliative Care, Primary Health Care
- Keywords
- implementation, anticipatory care planning, symptom assessment, interdisciplinary collaboration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bert LeysenUniversity, hospital or other
- Collaborators
- Intermutualistic Agency, National Institute for Health and Disability Insurance, Belgium
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Oct 2014 (estimated)
- 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.
It is important to provide high quality palliative care to all patients with a non-curable and life-limiting condition. The Care Pathway for Primary Palliative Care (CPPPC) provides tools for health care professionals to help them delivering palliative care timely and accurately.This study investigates whether the implementation of the CPPPC really helps to improve patients' lifes.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Research cluster 1: Antwerp | Other | Other: Care Pathway for Primary Palliative CareThe first Dutch-speaking research cluster in a stepped wedge cluster design. Family doctors are implementing the Care Pathway for Primary Palliative Care and will recruit eligible patients from October 2014. |
| Research cluster 2: Mons | Other | Other: Care Pathway for Primary Palliative CareThe first French-speaking research cluster in a stepped wedge cluster design. Family doctors are implementing the Care Pathway for Primary Palliative Care and will recruit eligible patients from November 2014. |
| Research cluster 3: Brussels | Other | Other: Care Pathway for Primary Palliative CareThe only bilingual Dutch/French-speaking research cluster in a stepped wedge cluster design. Family doctors are implementing the Care Pathway for Primary Palliative Care and will recruit eligible patients from December 2014. |
| Research cluster 4: Limburg | Other | Other: Care Pathway for Primary Palliative CareThe second Dutch-speaking research cluster in a stepped wedge cluster design. Family doctors will implement the Care Pathway for Primary Palliative Care and will recruit eligible patients from April 2015. |
| Research cluster 5: ? | Other | Other: Care Pathway for Primary Palliative CareA second French-speaking research cluster in a stepped wedge cluster design. Family doctors will implement the Care Pathway for Primary Palliative Care and will recruit eligible patients from October 2015. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- identified as a palliative care patient using the Surprise Question "Would you, as a family doctor, be surprised if this patient would die in the next 12 months?". If the answer is 'no', the patient is eligible for the study.
Key exclusion criteria (1 listed)
- not having signed the informed consent.
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 |
|---|---|---|
| Care Pathway for Primary Palliative CareAlso: CPPPCEarly identification of palliative care patients, anticipatory care planning, systematic symptom assessment, interdisciplinary collaboration, rigorous follow-up of the functional status of the patient and giving attention to the informal care givers. | Other | Research cluster 1: Antwerp, Research cluster 2: Mons, Research cluster 3: Brussels, Research cluster 4: Limburg, Research cluster 5: ? |
Primary outcome
percentage of deaths occurred in the hospital (of patients per family doctor/per research cluster)
Time frame: 6 months
The hypothesis is that the CPPPC reduces the percentage of deaths occurred in the hospital
4 secondary outcomes
cost of health care consumption in the last year of life (of patients per family doctor/per research cluster)
Time frame: 6 months
consumption of antibiotics in the last year of life (of patients per family doctor/per research cluster)
Time frame: 6 months
consumption of pain killers in the last year of life (of patients per family doctor/per research cluster)
Time frame: 6 months
consumption of (invasive) diagnostic and therapeutic procedures in the last year of life (of patients per family doctor/per research cluster)
Time frame: 6 months
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 2017.
- Derived from this study: PubMed 30836994Leysen B, Van den Eynden B, Janssens A, Wens J. Recruiting general practitioners for palliative care research in primary care: real-life barriers explained. BMC Fam Pract. 2019 Mar 5;20(1):40. doi: 10.1186/s12875-019-0930-y.
- Derived from this study: PubMed 26416574Leysen B, Van den Eynden B, Gielen B, Bastiaens H, Wens J. Implementation of a Care Pathway for Primary Palliative Care in 5 research clusters in Belgium: quasi-experimental study protocol and innovations in data collection (pro-SPINOZA). BMC Palliat Care. 2015 Sep 28;14:46. doi: 10.1186/s12904-015-0043-x.
- Related InfoLink provided by the sponsor.
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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.
Bart Van den Eynden, MD, PhD principal investigator
Universiteit Antwerpen
Johan Wens, MD, PhD principal investigator
Universiteit Antwerpen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Pathway for Primary Palliative Care in people with Palliative Care and Primary Health Care, run by Bert Leysen at 4 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. 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?
percentage of deaths occurred in the hospital (of patients per family doctor/per research cluster) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02266069, which also lists 2 linked publications.
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 2017.