Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-03-04 @ 12:44 AM
Study NCT ID:
NCT02266069
Status:
COMPLETED
Last Update Posted:
2017-11-29
First Post:
2014-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PROject - Supportive and Palliative Care and INnOvation - Antwerp (Pro-Spinoza)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019091', 'term': 'Critical Pathways'}], 'ancestors': [{'id': 'D010347', 'term': 'Patient Care Planning'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-27', 'studyFirstSubmitDate': '2014-10-10', 'studyFirstSubmitQcDate': '2014-10-10', 'lastUpdatePostDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of deaths occurred in the hospital (of patients per family doctor/per research cluster)', 'timeFrame': '6 months', 'description': 'The hypothesis is that the CPPPC reduces the percentage of deaths occurred in the hospital'}], 'secondaryOutcomes': [{'measure': 'cost of health care consumption in the last year of life (of patients per family doctor/per research cluster)', 'timeFrame': '6 months', 'description': 'The hypothesis is that the CPPPC reduces the cost of health care consumption in the last year of life'}, {'measure': 'consumption of antibiotics in the last year of life (of patients per family doctor/per research cluster)', 'timeFrame': '6 months', 'description': 'The hypothesis is that the CPPPC reduces the consumption of antibiotics in the last year of life'}, {'measure': 'consumption of pain killers in the last year of life (of patients per family doctor/per research cluster)', 'timeFrame': '6 months', 'description': 'The hypothesis is that the CPPPC augments the consumption of pain killers in the last year of life'}, {'measure': 'consumption of (invasive) diagnostic and therapeutic procedures in the last year of life (of patients per family doctor/per research cluster)', 'timeFrame': '6 months', 'description': 'The hypothesis is that the CPPPC reduces the consumption of (invasive) diagnostic and therapeutic procedures in the last year of life'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['implementation', 'anticipatory care planning', 'symptom assessment', 'interdisciplinary collaboration'], 'conditions': ['Palliative Care', 'Primary Health Care']}, 'referencesModule': {'references': [{'pmid': '30836994', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '26416574', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.pro-spinoza.be', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* not having signed the informed consent.'}, 'identificationModule': {'nctId': 'NCT02266069', 'acronym': 'pro-Spinoza', 'briefTitle': 'PROject - Supportive and Palliative Care and INnOvation - Antwerp (Pro-Spinoza)', 'organization': {'class': 'OTHER', 'fullName': 'Universiteit Antwerpen'}, 'officialTitle': 'Implementation of the Care Pathway for Primary Palliative Care in Five Research Clusters in Belgium', 'orgStudyIdInfo': {'id': 'UA C130298'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Research cluster 1: Antwerp', 'description': '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.', 'interventionNames': ['Other: Care Pathway for Primary Palliative Care']}, {'type': 'OTHER', 'label': 'Research cluster 2: Mons', 'description': '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.', 'interventionNames': ['Other: Care Pathway for Primary Palliative Care']}, {'type': 'OTHER', 'label': 'Research cluster 3: Brussels', 'description': '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.', 'interventionNames': ['Other: Care Pathway for Primary Palliative Care']}, {'type': 'OTHER', 'label': 'Research cluster 4: Limburg', 'description': '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.', 'interventionNames': ['Other: Care Pathway for Primary Palliative Care']}, {'type': 'OTHER', 'label': 'Research cluster 5: ?', 'description': '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.', 'interventionNames': ['Other: Care Pathway for Primary Palliative Care']}], 'interventions': [{'name': 'Care Pathway for Primary Palliative Care', 'type': 'OTHER', 'otherNames': ['CPPPC'], 'description': '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.', 'armGroupLabels': ['Research cluster 1: Antwerp', 'Research cluster 2: Mons', 'Research cluster 3: Brussels', 'Research cluster 4: Limburg', 'Research cluster 5: ?']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mons', 'state': 'Hainaut', 'country': 'Belgium', 'facility': 'Reliance', 'geoPoint': {'lat': 50.45413, 'lon': 3.95229}}, {'city': 'Hasselt', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Netwerk Palliatieve Zorg Limburg', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Palliatieve Hulpverlening Antwerpen', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Brussels-Capital Region', 'country': 'Belgium', 'facility': 'Palliabru'}], 'overallOfficials': [{'name': 'Bart Van den Eynden, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiteit Antwerpen'}, {'name': 'Johan Wens, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiteit Antwerpen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bert Leysen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Intermutualistic Agency', 'class': 'OTHER'}, {'name': 'National Institute for Health and Disability Insurance, Belgium', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD candidate', 'investigatorFullName': 'Bert Leysen', 'investigatorAffiliation': 'Universiteit Antwerpen'}}}}