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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bert Leysen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Intermutualistic Agency
National Institute for Health and Disability Insurance, Belgium

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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