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CompletedNCT02266069pro-SpinozaUpdated Nov 29, 2017

PROject - Supportive and Palliative Care and INnOvation - Antwerp (Pro-Spinoza)

An interventional study of Care Pathway for Primary Palliative Care in Palliative Care and Primary Health Care, sponsored by Bert Leysen. Completed at 4 sites in Belgium. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2017-11-29.

Sponsored by Bert Leysen · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
45 Years and older
Sex
All
01

Study 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 implementation of the CPPPC really helps to improve patients' lifes.

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Conditions studied

  • Palliative Care
  • Primary Health Care

Keywords

  • implementation
  • anticipatory care planning
  • symptom assessment
  • interdisciplinary collaboration
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In context

Lead sponsor

This is the only study on the registry with Bert Leysen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • not having signed the informed consent.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Other
    Research cluster 1: Antwerp

    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.

    Other: Care Pathway for Primary Palliative Care

  • Other
    Research cluster 2: Mons

    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.

    Other: Care Pathway for Primary Palliative Care

  • Other
    Research cluster 3: Brussels

    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.

    Other: Care Pathway for Primary Palliative Care

  • Other
    Research cluster 4: Limburg

    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.

    Other: Care Pathway for Primary Palliative Care

  • Other
    Research cluster 5: ?

    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.

    Other: Care Pathway for Primary Palliative Care

Interventions

  • OtherCare Pathway for Primary Palliative Care

    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.

    Also known as: CPPPC

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

Secondary outcomes

  1. 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

    Time frame: 6 months

  2. 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

    Time frame: 6 months

  3. 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

    Time frame: 6 months

  4. 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

    Time frame: 6 months

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Study locations

4 sites
  • Reliance
    Mons, Hainaut, Belgium
  • Netwerk Palliatieve Zorg Limburg
    Hasselt, Limburg, Belgium
  • Palliatieve Hulpverlening Antwerpen
    Antwerp, Belgium
  • Palliabru
    Brussels-Capital Region, Belgium
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References and documents

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 30836994 ↗
  • Leysen 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 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02266069
Lead sponsor
Bert Leysen
Collaborators
Intermutualistic Agency, National Institute for Health and Disability Insurance, Belgium
Responsible party
Bert Leysen (MD, PhD candidate, Universiteit Antwerpen) — Sponsor-investigator
First posted
Oct 16, 2014
Start date
Oct 2014
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Nov 29, 2017

Study contacts

Bart Van den Eynden, MD, PhD
principal investigator · Universiteit Antwerpen
Johan Wens, MD, PhD
principal investigator · Universiteit Antwerpen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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