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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02266069
Recruitment Status : Completed
First Posted : October 16, 2014
Last Update Posted : November 29, 2017
Sponsor:
Collaborators:
Intermutualistic Agency
National Institute for Health and Disability Insurance, Belgium
Information provided by (Responsible Party):
Bert Leysen, Universiteit Antwerpen

Brief 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.

Condition or disease Intervention/treatment Phase
Palliative Care Primary Health Care Other: Care Pathway for Primary Palliative Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementation of the Care Pathway for Primary Palliative Care in Five Research Clusters in Belgium
Study Start Date : October 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.
Other Name: CPPPC

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
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.
Other Name: CPPPC

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
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.
Other Name: CPPPC

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
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.
Other Name: CPPPC

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
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.
Other Name: CPPPC




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. cost of health care consumption in the last year of life (of patients per family doctor/per research cluster) [ Time Frame: 6 months ]
    The hypothesis is that the CPPPC reduces the cost of health care consumption in the last year of life

  2. consumption of antibiotics in the last year of life (of patients per family doctor/per research cluster) [ Time Frame: 6 months ]
    The hypothesis is that the CPPPC reduces the consumption of antibiotics in the last year of life

  3. consumption of pain killers in the last year of life (of patients per family doctor/per research cluster) [ Time Frame: 6 months ]
    The hypothesis is that the CPPPC augments the consumption of pain killers in the last year of life

  4. 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 ]
    The hypothesis is that the CPPPC reduces the consumption of (invasive) diagnostic and therapeutic procedures in the last year of life



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • not having signed the informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266069


Locations
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Belgium
Reliance
Mons, Hainaut, Belgium
Netwerk Palliatieve Zorg Limburg
Hasselt, Limburg, Belgium
Palliatieve Hulpverlening Antwerpen
Antwerp, Belgium
Palliabru
Brussels-Capital Region, Belgium
Sponsors and Collaborators
Bert Leysen
Intermutualistic Agency
National Institute for Health and Disability Insurance, Belgium
Investigators
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Principal Investigator: Bart Van den Eynden, MD, PhD Universiteit Antwerpen
Principal Investigator: Johan Wens, MD, PhD Universiteit Antwerpen
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bert Leysen, MD, PhD candidate, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT02266069    
Other Study ID Numbers: UA C130298
First Posted: October 16, 2014    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Keywords provided by Bert Leysen, Universiteit Antwerpen:
implementation
anticipatory care planning
symptom assessment
interdisciplinary collaboration