Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-01-02 @ 1:33 AM
Study NCT ID:
NCT01449734
Status:
COMPLETED
Last Update Posted:
2013-11-11
First Post:
2011-09-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Family Satisfaction (FS) in the Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'christiane.hartog@med.uni-jena.de', 'phone': '+49 3641 9323171', 'title': 'Christiane Hartog, MD', 'organization': 'CSCC Germany, Jena University Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'March to November 2011', 'description': 'No adverse events were expected by conducting the survey among family members of ICU patients. Thus adverse events were not assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Family Satisfaction', 'description': 'family satisfaction in the intensive care unit (ICU) and areas for improvement', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Patient Severity of Illness', 'timeFrame': 'From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Length of Stay on the ICU', 'timeFrame': 'From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Mortality', 'timeFrame': 'From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Family Satisfaction in the ICU (FS-ICU) Questionnaire- Overall Satisfaction Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Family Satisfaction', 'description': 'All 215 surveyed relatives are contained in this group, since the study was observational without intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.3', 'spread': '14.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months', 'description': 'Overall satisfaction score is calculated as the mean of 24 Items concerning satisfaction with care, communication and decision-making. After transformation of Items the score has a scale reaching from 0 (highly unsatisfied) to 100 (highly satisfied).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'By invitation'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Family Satisfaction', 'description': 'family satisfaction in the intensive care unit (ICU) and areas for improvement'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Prospective cohort study performed in four (mixed surgical, neurological, and cardiological) intensive care units of a university hospital in Germany'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Family Satisfaction', 'description': 'family satisfaction in the intensive care unit (ICU) and areas for improvement'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-34', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': '35-44', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}, {'title': '45-54', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}, {'title': '55-64', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}, {'title': '> 64', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Numbers in categories do not add to 215 because of non-response.', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Gender of participating relatives. Numbers do not add to 215 because of non-response.', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Visiting family members'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 217}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-04', 'studyFirstSubmitDate': '2011-09-30', 'resultsFirstSubmitDate': '2013-02-26', 'studyFirstSubmitQcDate': '2011-10-07', 'lastUpdatePostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-04', 'studyFirstPostDateStruct': {'date': '2011-10-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Family Satisfaction in the ICU (FS-ICU) Questionnaire- Overall Satisfaction Score', 'timeFrame': 'From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months', 'description': 'Overall satisfaction score is calculated as the mean of 24 Items concerning satisfaction with care, communication and decision-making. After transformation of Items the score has a scale reaching from 0 (highly unsatisfied) to 100 (highly satisfied).'}], 'secondaryOutcomes': [{'measure': 'Patient Severity of Illness', 'timeFrame': 'From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months'}, {'measure': 'Patient Length of Stay on the ICU', 'timeFrame': 'From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months'}, {'measure': 'Patient Mortality', 'timeFrame': 'From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Critical Illness']}, 'referencesModule': {'references': [{'pmid': '17133189', 'type': 'BACKGROUND', 'citation': 'Wall RJ, Engelberg RA, Downey L, Heyland DK, Curtis JR. Refinement, scoring, and validation of the Family Satisfaction in the Intensive Care Unit (FS-ICU) survey. Crit Care Med. 2007 Jan;35(1):271-9. doi: 10.1097/01.CCM.0000251122.15053.50.'}, {'pmid': '12130954', 'type': 'BACKGROUND', 'citation': "Heyland DK, Rocker GM, Dodek PM, Kutsogiannis DJ, Konopad E, Cook DJ, Peters S, Tranmer JE, O'Callaghan CJ. Family satisfaction with care in the intensive care unit: results of a multiple center study. Crit Care Med. 2002 Jul;30(7):1413-8. doi: 10.1097/00003246-200207000-00002."}, {'pmid': '19730813', 'type': 'BACKGROUND', 'citation': 'Stricker KH, Kimberger O, Schmidlin K, Zwahlen M, Mohr U, Rothen HU. Family satisfaction in the intensive care unit: what makes the difference? Intensive Care Med. 2009 Dec;35(12):2051-9. doi: 10.1007/s00134-009-1611-4.'}, {'pmid': '23417207', 'type': 'DERIVED', 'citation': 'Schwarzkopf D, Behrend S, Skupin H, Westermann I, Riedemann NC, Pfeifer R, Gunther A, Witte OW, Reinhart K, Hartog CS. Family satisfaction in the intensive care unit: a quantitative and qualitative analysis. Intensive Care Med. 2013 Jun;39(6):1071-9. doi: 10.1007/s00134-013-2862-7. Epub 2013 Feb 16.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/23417207', 'label': 'Publication of study results'}]}, 'descriptionModule': {'briefSummary': 'There is increasing awareness that high-quality care in the intensive care unit also includes care of visiting family members according to their needs. The investigators therefore want to assess family satisfaction using a questionnaire that was specially developed for this setting and recently validated for German-speaking participants.', 'detailedDescription': 'Family members who visit patients on the ICU (intensive care unit) are not just onlookers. They experience the process of care along with their loved ones. Increasingly, the satisfaction of family members with ICU care, decision-making and information, and their empowerment to contribute towards patient care as near relatives, is being perceived as an important aspect of the general quality of ICU care.\n\nFamily satisfaction is assessed using the 34-item FS-ICU questionnaire which was recently validated for German-speaking participants.\n\nThe aim of this pilot survey is to identify opportunities for improvement of family satisfaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Visiting family members of patients being treated in the ICU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all visiting family members who consent to participate\n\nExclusion Criteria:\n\n* no more than two family members per patient;\n* prior participation'}, 'identificationModule': {'nctId': 'NCT01449734', 'briefTitle': 'Family Satisfaction (FS) in the Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Center for Sepsis Control and Care, Germany'}, 'officialTitle': 'Observational Study of Family Satisfaction in the Intensive Care Unit Using the German-language FS-ICU', 'orgStudyIdInfo': {'id': 'Jena FS-ICU'}}, 'contactsLocationsModule': {'locations': [{'zip': 'D-07743', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Intensive Care Units of the University Hospital Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'overallOfficials': [{'name': 'Christiane S Hartog, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jena University Hospital, Dpt. of Anesthesiology and Intensive Care Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Sepsis Control and Care, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Christiane Hartog', 'investigatorAffiliation': 'Center for Sepsis Control and Care, Germany'}}}}