Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-27 @ 7:00 PM
Study NCT ID:
NCT04905095
Status:
COMPLETED
Last Update Posted:
2025-02-12
First Post:
2021-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CSAPG Early Warning Score
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075902', 'term': 'Clinical Deterioration'}], 'ancestors': [{'id': 'D018450', 'term': 'Disease Progression'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15998}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2021-05-24', 'studyFirstSubmitQcDate': '2021-05-24', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital stay', 'timeFrame': 'from baseline to hospital discharge, as much 3 months', 'description': 'Average days of hospital admission'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'from baseline to hospital discharge, as much 3 months', 'description': 'Percentage of patients deceased during hospital admission'}, {'measure': 'Complications', 'timeFrame': 'from baseline to hospital discharge, as much 3 months', 'description': 'Percentage of patients who develop health complications during hospital admission'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hospital Stay', 'Mortality', 'Clinical Deterioration'], 'conditions': ['Undefined']}, 'descriptionModule': {'briefSummary': 'The Early Warning Score (EWS) has been shown in previous studies to be correlated with mortality and mean hospital stay, but it is unknown whether the implementation of the scale improves mortality and mean hospital stay.\n\nThis trial aims to study whether the implantation of the EWS in a regional hospital reduces the mean hospital stay (primary objective), mortality and complications (secondary objectives).\n\nFor this, an open clinical trial will be carried out in which the hospitalization floors of the hospital will be administratively divided into two sections (two study branches); the EWS scale will be implemented in the computer equipment of one of the sections of each floor, acting the another section as a control branch.\n\nAll the patients admitted to the participating hospital floors during one year will be included in the study. The mean stay, mortality and complications will be compared between study branches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted during study period to the participant hospital units.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04905095', 'acronym': 'CEWS', 'briefTitle': 'CSAPG Early Warning Score', 'organization': {'class': 'OTHER', 'fullName': "Consorci Sanitari de l'Alt Penedès i Garraf"}, 'officialTitle': 'CSAPG Early Warning Score', 'orgStudyIdInfo': {'id': 'CSAPG-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EWS', 'description': 'Early Warning Score will be implemented in the computer system of the nursing station', 'interventionNames': ['Other: EWS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Nursing supervision will be carried out in the usual way.', 'interventionNames': ['Other: usual clinical care']}], 'interventions': [{'name': 'EWS', 'type': 'OTHER', 'description': 'Early Warning Score will be implemented in the computer system of the nursing station which belong to this intervention group. When the nurses enter the vital signs of the patients into the system, the EWS will be automatically calculated and an alarm will be displayed if an intervention is necessary, which is protocolized.', 'armGroupLabels': ['EWS']}, {'name': 'usual clinical care', 'type': 'OTHER', 'description': 'Nurses perform their clinical monitoring activities as usual. EWS will not be implemented in their nursing station', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vilafranca del Penedès', 'state': 'Barcelona', 'country': 'Spain', 'facility': "Consorci Sanitari de l'Alt Penedès i Garraf", 'geoPoint': {'lat': 41.34618, 'lon': 1.69713}}], 'overallOfficials': [{'name': 'Cristina Ramos, Nurse', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CSAPG'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After publication of main results of the study.', 'ipdSharing': 'YES', 'description': 'IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research proposels and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).', 'accessCriteria': 'IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Consorci Sanitari de l'Alt Penedès i Garraf", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}