Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-03-11 @ 9:22 PM
Study NCT ID:
NCT06597318
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trends of Patient-reported Outcome Measures (PROMs) in Multimorbid Medical Patients Hospitalized for an Acute Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006760', 'term': 'Hospitalization'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-12', 'studyFirstSubmitDate': '2024-08-21', 'studyFirstSubmitQcDate': '2024-09-12', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of PROMS with the risk of readmission', 'timeFrame': 'Day 1, Day 3, at the day of discharge (approximately day 8) and Day 30 after discharge from Hospital', 'description': 'The primary objective of the project is to explore trends in PROMs (using the Edmonton Symptom Assessment System (ESAS-r), the EQ-5D-5L index,45 and the National Comprehensive Cancer Network (NCCN) distress thermometer) of multimorbid medical hospitalized patients, from admission until 30-days post-discharge. The patients-reported outcomes will consist of patients-reported symptoms, quality of life and distress'}], 'secondaryOutcomes': [{'measure': 'Correlation of PROMs at discharge and risk of hospital readmission or ED visits', 'timeFrame': 'Day 30 after discharge from hospital', 'description': 'assess whether PROMs ((using the Edmonton Symptom Assessment System (ESAS-r), the EQ-5D-5L index,45 and the National Comprehensive Cancer Network (NCCN) distress thermometer) at discharge are associated with the risk of hospital readmission or of emergency department visit within the next 30 days;'}, {'measure': 'Exploration of PROMs in patients who receive low-value care', 'timeFrame': 'Day 1, Day 3, at the day of discharge (approximately day 8) and Day 30 after discharge from Hospital', 'description': 'explore whether PROMs ((using the Edmonton Symptom Assessment System (ESAS-r), the EQ-5D-5L index,45 and the National Comprehensive Cancer Network (NCCN) distress thermometer) trends vary in patients who do or do not receive low value care (LVC);'}, {'measure': 'Explore PREMs', 'timeFrame': 'Since 24 hours after beginning of the hospitalization up to Discharge from Hospital (approximately day 8)', 'description': "Explore information on Patient Reported Experiences Measures (PREMs) using a qualitative questionnaire during patients' stay at the hospital, and whether there is a correlation between the provision of LVC and qualitative analysis of PREMs"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PROM', 'PREM', 'Quality of Care', 'Internal Medicine']}, 'descriptionModule': {'briefSummary': 'currently, PROMs and PREMs are not routinely collected and compared among medical inpatients of Swiss university hospitals, nor is a standard set of PROMs and PREMs available for use in Swiss hospitals. The project aims to examine trends in patient-reported outcomes (PROMs), including symptoms, quality of life, and distress, in multimorbid hospitalized patients from admission to 30 days post-discharge. It will also investigate whether PROMs at discharge are linked to the risk of readmission or emergency visits and explore how these outcomes differ in patients who receive low-value care. Additionally, the project will assess the relationship between patient-reported experiences (PREMs) and the provision of low-value care during the hospital stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with 2 or more chronic diseases, hospitalized in general internal medicine divisions of all five Swiss university hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* eligible for the LUCID registry (CER-VD AO\\_2023-00029) \\[Age ≥ 18 years, hospitalized in one of the five participating university hospitals (Geneva, Lausanne, Bern, Zürich, Basel), after 01.01.2014, and admitted to general internal medicine wards\n* Multimorbid patients (2 or more chronic diseases, defined as chronic conditions defined by international classification of diseases, 10th revision, codes with an estimated expected duration of at least 6 months or based on a clinical decision.\n* Acute illness\n* Signature of study specific informed consent\n\nExclusion Criteria:\n\n* Not able to speak French, German or English\n* Foreseen length of stay of less than 4 days (estimated by study collaborators)\n* Prior inclusion in the TRADUCE study\n* Incapacity of discernment, i.e. cognitive impairment which could interfere with the ability to fill in PROMs tools'}, 'identificationModule': {'nctId': 'NCT06597318', 'acronym': 'TRADUCE', 'briefTitle': 'Trends of Patient-reported Outcome Measures (PROMs) in Multimorbid Medical Patients Hospitalized for an Acute Illness', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne Hospitals'}, 'officialTitle': 'Trends of Patient-reported Outcome Measures (PROMs) in Multimorbid Medical Patients Hospitalized for an Acute Illness', 'orgStudyIdInfo': {'id': '2023-00200'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'multimorbid patients in general internal medicine divisions of all five Swiss university hospitals', 'interventionNames': ['Other: Hospitalization']}], 'interventions': [{'name': 'Hospitalization', 'type': 'OTHER', 'description': 'The investigators collect PROMs amongst up to 1000 patients in general internal medicine divisions of all five Swiss university hospitals', 'armGroupLabels': ['multimorbid patients in general internal medicine divisions of all five Swiss university hospitals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1005', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Marie Mean', 'role': 'CONTACT', 'phone': '+41213141111'}], 'facility': 'Lausanne University Hospital', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'centralContacts': [{'name': 'Marie Méan, MD', 'role': 'CONTACT', 'email': 'marie.mean@chuv.ch', 'phone': '+41 213141111'}], 'overallOfficials': [{'name': 'Jerome Stirnemann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Geneva'}, {'name': 'Carole Aubert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bern University Hospital'}, {'name': 'Florence Vallelian Cervetto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zürich University Hospital'}, {'name': 'Stefano Bassetti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Basel University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}, 'collaborators': [{'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, {'name': 'University Hospital, Zürich', 'class': 'OTHER'}, {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Senior Physician', 'investigatorFullName': 'Marie Méan', 'investigatorAffiliation': 'University of Lausanne Hospitals'}}}}