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

November 27, 2017 updated by: Bert Leysen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium
        • Palliatieve Hulpverlening Antwerpen
      • Brussels-Capital Region, Belgium
        • Palliabru
    • Hainaut
      • Mons, Hainaut, Belgium
        • Reliance
    • Limburg
      • Hasselt, Limburg, Belgium
        • Netwerk Palliatieve Zorg Limburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 Names:
  • CPPPC
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
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 Names:
  • CPPPC
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
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 Names:
  • CPPPC
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
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 Names:
  • CPPPC
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
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 Names:
  • CPPPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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
6 months
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
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
The hypothesis is that the CPPPC reduces the consumption of (invasive) diagnostic and therapeutic procedures in the last year of life
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bert Leysen

Collaborators

Intermutualistic Agency
National Institute for Health and Disability Insurance, Belgium

Investigators

  • Principal Investigator: Bart Van den Eynden, MD, PhD, Universiteit Antwerpen
  • Principal Investigator: Johan Wens, MD, PhD, Universiteit Antwerpen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

October 10, 2014

First Posted (Estimate)

October 16, 2014

Study Record Updates

Last Update Posted (Actual)

November 29, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UA C130298

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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