Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-01-03 @ 9:03 AM
Study NCT ID:
NCT04036058
Status:
COMPLETED
Last Update Posted:
2025-07-11
First Post:
2019-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Expanding (Gloving) Barrier Precautions for Reducing Clostridium Difficile Acquisition (and Infection) in VA
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'linda.mckinley2@va.gov', 'phone': '608-256-1901', 'title': 'Linda McKinley', 'organization': 'Wm. S. Middleton Memorial VA Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': "Central institutional review board (CIRB) determination for written informed consent led to low enrollment numbers; limited 24/7 availability of research coordinators and burden to busy clinicians and hospitalized patients. Therefore, the primary aim (C. difficile acquisition) was not adequately powered to detect differences. Other real-world challenges to study enrollment was the ongoing corona virus disease of 2019 (COVID-19) pandemic which wasn't officially declared over until May 2023."}}, 'adverseEventsModule': {'timeFrame': 'during hospitalization, up to one month', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Enact universal gloving practices\n\nUniversal gloving: The intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing universal gloving (non-sterile gloves) for all patient contacts in the units that are randomized to receive the intervention. If a patient in the intervention unit is known to have CDI or a multidrug-resistant organisms, both gowns and gloves will be used as is currently recommended. Signage denoting what type of precautions are needed will be utilized.', 'otherNumAtRisk': 470, 'deathsNumAtRisk': 470, 'otherNumAffected': 0, 'seriousNumAtRisk': 470, 'deathsNumAffected': 28, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Continue standard of care gloving practices', 'otherNumAtRisk': 310, 'deathsNumAtRisk': 310, 'otherNumAffected': 0, 'seriousNumAtRisk': 310, 'deathsNumAffected': 26, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'C. Difficile Acquisition Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}, {'units': 'patient days of care', 'counts': [{'value': '988', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Enact universal gloving practices\n\nUniversal gloving: The intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing universal gloving (non-sterile gloves) for all patient contacts in the units that are randomized to receive the intervention. If a patient in the intervention unit is known to have CDI or a multidrug-resistant organisms, both gowns and gloves will be used as is currently recommended. Signage denoting what type of precautions are needed will be utilized.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Continue standard of care gloving practices'}], 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '20.3'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '18.0'}]}]}], 'analyses': [{'pValue': '0.611', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'during hospitalization, approximately 5 days', 'description': "Acquisition will be defined as a patient who has an initial stool culture upon unit admission that is negative for C. difficile and the patient's subsequent discharge culture within the same unit that is positive for C. difficile. Acquisition rate will be (# of acquisitions/patient days)", 'unitOfMeasure': 'C. diff acquisition per patient days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'patient days of care', 'denomUnitsSelected': 'patient days of care', 'populationDescription': 'The intervention group had 5569 patient admissions in 5 participating units with 988 patient days of care; 303 subjects had both admission and discharge specimens with 13 that acquired c. difficile (c. difficile negative upon admission and positive upon discharge). The control group had 4412 patient admissions in 5 participating units with 674 patient days of care; 171 subjects had both admission and discharge specimens with 7 that acquired c. difficile.'}, {'type': 'SECONDARY', 'title': 'Hospital-onset C. Difficile Infection (HO-CDI) Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5369', 'groupId': 'OG000'}, {'value': '4412', 'groupId': 'OG001'}]}, {'units': 'patient days of care', 'counts': [{'value': '37842', 'groupId': 'OG000'}, {'value': '40310', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Enact universal gloving practices\n\nUniversal gloving: The intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing universal gloving (non-sterile gloves) for all patient contacts in the units that are randomized to receive the intervention. If a patient in the intervention unit is known to have CDI or a multidrug-resistant organisms, both gowns and gloves will be used as is currently recommended. Signage denoting what type of precautions are needed will be utilized.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Continue standard of care gloving practices'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2379', 'groupId': 'OG000', 'lowerLimit': '0.0825', 'upperLimit': '0.3932'}, {'value': '0.5210', 'groupId': 'OG001', 'lowerLimit': '0.2982', 'upperLimit': '0.7437'}]}]}], 'analyses': [{'pValue': '0.0435', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'monthly, up to 18 months', 'description': 'The development of CDI as determined by the presence of clinical symptoms and positive laboratory results. Infection rates will be measured on the unit level. Infection rate will be (# of CDI/patient days)', 'unitOfMeasure': 'CDI per patient days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'patient days of care', 'denomUnitsSelected': 'patient days of care', 'populationDescription': 'In the intervention group there were 5369 patient admitted in the 5 participating inpatient hospital units with 37842 patient days of care. The intervention group had 5569 patient admissions in 5 participating units with 37842 patient days of care; 9 subjects developed CDI. The control group had 4412 patient admissions in 5 participating units with 40310 patient days of care; 21 subjects developed CDI.'}, {'type': 'SECONDARY', 'title': 'MRSA (HAI) Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5369', 'groupId': 'OG000'}, {'value': '4412', 'groupId': 'OG001'}]}, {'units': 'patient days of care', 'counts': [{'value': '37843', 'groupId': 'OG000'}, {'value': '40310', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Enact universal gloving practices\n\nUniversal gloving: The intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing universal gloving (non-sterile gloves) for all patient contacts in the units that are randomized to receive the intervention. If a patient in the intervention unit is known to have CDI or a multidrug-resistant organisms, both gowns and gloves will be used as is currently recommended. Signage denoting what type of precautions are needed will be utilized.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Continue standard of care gloving practices'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0528', 'groupId': 'OG000', 'lowerLimit': '-0.0204', 'upperLimit': '0.1261'}, {'value': '0.1737', 'groupId': 'OG001', 'lowerLimit': '0.0450', 'upperLimit': '0.3022'}]}]}], 'analyses': [{'pValue': '0.1158', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'monthly, up to 18 months', 'description': 'The rates of healthcare-associated methicillin-resistant Staphylococcus aureus (MRSA) infection will be measured as (# of MRSA cases/patient days) on the unit level.', 'unitOfMeasure': 'MRSA per patient days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'patient days of care', 'denomUnitsSelected': 'patient days of care', 'populationDescription': 'The control had 4412 admissions in 5 units with 40310 patient days; 7 subjects developed MRSA.\n\nThe intervention group had 5369 patient admissions in 5 participating units with 37843 patient days of care; 2 subjects developed MRSA. The control group had 4412 patient admissions in 5 participating units with 40310 patient days of care; 7 subjects developed MRSA.'}, {'type': 'SECONDARY', 'title': 'CLABSI (HAI) Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5569', 'groupId': 'OG000'}, {'value': '4412', 'groupId': 'OG001'}]}, {'units': 'line days of care', 'counts': [{'value': '4846', 'groupId': 'OG000'}, {'value': '5100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Enact universal gloving practices\n\nUniversal gloving: The intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing universal gloving (non-sterile gloves) for all patient contacts in the units that are randomized to receive the intervention. If a patient in the intervention unit is known to have CDI or a multidrug-resistant organisms, both gowns and gloves will be used as is currently recommended. Signage denoting what type of precautions are needed will be utilized.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Continue standard of care gloving practices'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0318', 'groupId': 'OG000', 'lowerLimit': '0.1279', 'upperLimit': '1.9357'}, {'value': '0.1961', 'groupId': 'OG001', 'lowerLimit': '-0.1882', 'upperLimit': '0.5804'}]}]}], 'analyses': [{'pValue': '0.0898', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'monthly, up to 18 months', 'description': 'The rates of healthcare-associated central line-associated bloodstream infection (CLABSI) will be measured as (# of CLABSI cases per number of device days) on the unit level.', 'unitOfMeasure': 'CLABSI per central line days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'line days of care', 'denomUnitsSelected': 'line days of care', 'populationDescription': 'The intervention group had 5569 patient admissions in 5 participating units with 4846 line days of care; 5 subjects developed CLABSI. The control group had 4412 patient admissions in 5 participating units with 5100 line days of care; 1 subjects developed CLABSI.'}, {'type': 'SECONDARY', 'title': 'CAUTI (HAI) Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5569', 'groupId': 'OG000'}, {'value': '4412', 'groupId': 'OG001'}]}, {'units': 'catheter days of care', 'counts': [{'value': '4807', 'groupId': 'OG000'}, {'value': '5763', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Enact universal gloving practices\n\nUniversal gloving: The intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing universal gloving (non-sterile gloves) for all patient contacts in the units that are randomized to receive the intervention. If a patient in the intervention unit is known to have CDI or a multidrug-resistant organisms, both gowns and gloves will be used as is currently recommended. Signage denoting what type of precautions are needed will be utilized.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Continue standard of care gloving practices'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.5206', 'groupId': 'OG001', 'lowerLimit': '-0.0684', 'upperLimit': '1.1095'}]}]}], 'analyses': [{'pValue': '0.114', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'monthly, up to 18 months', 'description': 'The rates of healthcare-associated catheter-associated urinary tract infection (CAUTI) will be measured as (# of CAUTI cases per number of device days) on the unit level.', 'unitOfMeasure': 'CAUTI per foley catheter days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'catheter days of care', 'denomUnitsSelected': 'catheter days of care', 'populationDescription': 'The intervention group had 5569 patient admissions in 5 participating units with 4807 catheter days of care; 0 subjects developed CAUTI. The control group had 4412 patient admissions in 5 participating units with 5763 catheter days of care; 3 subjects developed CAUTI.'}, {'type': 'SECONDARY', 'title': 'Intervention Fidelity - Barrier Precaution Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '717', 'groupId': 'OG000'}]}, {'units': 'inpatient hospital units', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Enact universal gloving practices\n\nUniversal gloving: The intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing universal gloving (non-sterile gloves) for all patient contacts in the units that are randomized to receive the intervention. If a patient in the intervention unit is known to have CDI or a multidrug-resistant organisms, both gowns and gloves will be used as is currently recommended. Signage denoting what type of precautions are needed will be utilized.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.651', 'groupId': 'OG000', 'lowerLimit': '0.616', 'upperLimit': '0.686'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'monthly, up to 18 months', 'description': 'Healthcare worker barrier precaution compliance with unit-wide gloving practices during patient care activities will be measured via observations in participating units. Compliance will be measured as a percentage of use of appropriate gloving practices per opportunities for gloving practices.', 'unitOfMeasure': 'glove compliance per glove observations', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'inpatient hospital units', 'denomUnitsSelected': 'inpatient hospital units', 'populationDescription': 'This population represents healthcare worker glove compliance (intervention fidelity) rather than patient participant data.'}, {'type': 'SECONDARY', 'title': '30-day Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '988', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}]}, {'units': 'inpatient hospital units', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Enact universal gloving practices\n\nUniversal gloving: The intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing universal gloving (non-sterile gloves) for all patient contacts in the units that are randomized to receive the intervention. If a patient in the intervention unit is known to have CDI or a multidrug-resistant organisms, both gowns and gloves will be used as is currently recommended. Signage denoting what type of precautions are needed will be utilized.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Continue standard of care gloving practices'}], 'classes': [{'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000', 'lowerLimit': '18.0', 'upperLimit': '38.7'}, {'value': '38.6', 'groupId': 'OG001', 'lowerLimit': '24.0', 'upperLimit': '53.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during hospitalization, up to one month', 'description': 'Mortality will be defined as the number of patients who die per the number of patient days at risk during study period. Mortality rate will be (# of deaths/patient days)', 'unitOfMeasure': 'patient deaths per patient admission', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'inpatient hospital units', 'denomUnitsSelected': 'inpatient hospital units', 'populationDescription': 'participants that are reported in the Participant Flow differ from the baseline analysis population due to missing mortality data'}, {'type': 'SECONDARY', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '470', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}]}, {'units': 'inpatient hospital units', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Enact universal gloving practices\n\nUniversal gloving: The intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing universal gloving (non-sterile gloves) for all patient contacts in the units that are randomized to receive the intervention. If a patient in the intervention unit is known to have CDI or a multidrug-resistant organisms, both gowns and gloves will be used as is currently recommended. Signage denoting what type of precautions are needed will be utilized.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Continue standard of care gloving practices'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '0.295', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.770', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during hospitalization, approximately 5 days', 'description': 'the average number of days spent in the participating unit based on unit admission and unit discharge dates', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'inpatient hospital units', 'denomUnitsSelected': 'inpatient hospital units'}, {'type': 'SECONDARY', 'title': 'HAI Costs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5369', 'groupId': 'OG000'}, {'value': '4412', 'groupId': 'OG001'}]}, {'units': 'inpatient hospital units', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Enact universal gloving practices\n\nUniversal gloving: The intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing universal gloving (non-sterile gloves) for all patient contacts in the units that are randomized to receive the intervention. If a patient in the intervention unit is known to have CDI or a multidrug-resistant organisms, both gowns and gloves will be used as is currently recommended. Signage denoting what type of precautions are needed will be utilized.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Continue standard of care gloving practices'}], 'classes': [{'categories': [{'measurements': [{'value': '155349', 'groupId': 'OG000'}, {'value': '362460', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'through study completion, an average of 18 months', 'description': 'total costs in U.S. dollars attributed to the number of HAIs during study period', 'unitOfMeasure': 'U.S. dollars', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'inpatient hospital units', 'denomUnitsSelected': 'inpatient hospital units', 'populationDescription': 'Overall Number of Participants Analyzed is inconsistent with the total number of participants reported in the Participant Flow module because we used unit-level aggregate data rather than participant-level data.'}, {'type': 'SECONDARY', 'title': 'Supply Costs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5369', 'groupId': 'OG000'}]}, {'units': 'inpatient hospital units', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Enact universal gloving practices\n\nUniversal gloving: The intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing universal gloving (non-sterile gloves) for all patient contacts in the units that are randomized to receive the intervention. If a patient in the intervention unit is known to have CDI or a multidrug-resistant organisms, both gowns and gloves will be used as is currently recommended. Signage denoting what type of precautions are needed will be utilized.'}], 'classes': [{'categories': [{'measurements': [{'value': '42883', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'through study completion, an average of 18 months', 'description': 'total costs in U.S. dollars attributed to the number of gloves used during study period', 'unitOfMeasure': 'U.S. dollars', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'inpatient hospital units', 'denomUnitsSelected': 'inpatient hospital units', 'populationDescription': 'Overall Number of Participants Analyzed is inconsistent with the total number of participants reported in the Participant Flow module because we used unit-level aggregate data rather than participant-level data.'}, {'type': 'SECONDARY', 'title': 'Patient and Healthcare Worker Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Enact universal gloving practices\n\nUniversal gloving: The intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing universal gloving (non-sterile gloves) for all patient contacts in the units that are randomized to receive the intervention. If a patient in the intervention unit is known to have CDI or a multidrug-resistant organisms, both gowns and gloves will be used as is currently recommended. Signage denoting what type of precautions are needed will be utilized.'}], 'classes': [{'title': 'patient perceived no change in care', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'patient perceived no change in hcw hand hygiene', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'patient perceived no change in hcw work activities', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'months 12 - 18', 'description': 'Qualitative data describing the patient and healthcare worker experience with the intervention of universal gloving.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'there were 15 patient interviews and 23 employee interviews but thematic quantitative analysis was not conducted for employee interviews.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Enact universal gloving practices\n\nUniversal gloving: The intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing universal gloving (non-sterile gloves) for all patient contacts in the units that are randomized to receive the intervention. If a patient in the intervention unit is known to have CDI or a multidrug-resistant organisms, both gowns and gloves will be used as is currently recommended. Signage denoting what type of precautions are needed will be utilized.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Continue standard of care gloving practices'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '470'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '310'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '303'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '171'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '167'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '139'}]}]}], 'typeUnitsAnalyzed': 'inpatient hospital units'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '748', 'groupId': 'BG002'}]}, {'units': 'inpatient hospital units', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Enact universal gloving practices\n\nUniversal gloving: The intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing universal gloving (non-sterile gloves) for all patient contacts in the units that are randomized to receive the intervention. If a patient in the intervention unit is known to have CDI or a multidrug-resistant organisms, both gowns and gloves will be used as is currently recommended. Signage denoting what type of precautions are needed will be utilized.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Continue standard of care gloving practices'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '100'}, {'value': '72', 'groupId': 'BG001', 'lowerLimit': '30', 'upperLimit': '101'}, {'value': '71', 'groupId': 'BG002', 'lowerLimit': '29', 'upperLimit': '101'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '407', 'groupId': 'BG000'}, {'value': '283', 'groupId': 'BG001'}, {'value': '690', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '278', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '463', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'inpatient hospital units', 'populationDescription': 'participants that are reported in the Participant Flow differ from the baseline analysis population due to missing demographic data'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-07', 'size': 458741, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-10T18:31', 'hasProtocol': True}, {'date': '2023-08-27', 'size': 314528, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-10T18:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm parallel assignment: the 10 participating units will be randomized; at each site, one unit will be randomized to the intervention group and one unit to the control group so that 5 units will enact the universal gloving intervention and 5 units will continue standard of care gloving practices.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 780}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2019-07-24', 'resultsFirstSubmitDate': '2025-01-27', 'studyFirstSubmitQcDate': '2019-07-26', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-20', 'studyFirstPostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C. Difficile Acquisition Rates', 'timeFrame': 'during hospitalization, approximately 5 days', 'description': "Acquisition will be defined as a patient who has an initial stool culture upon unit admission that is negative for C. difficile and the patient's subsequent discharge culture within the same unit that is positive for C. difficile. Acquisition rate will be (# of acquisitions/patient days)"}], 'secondaryOutcomes': [{'measure': 'Hospital-onset C. Difficile Infection (HO-CDI) Rates', 'timeFrame': 'monthly, up to 18 months', 'description': 'The development of CDI as determined by the presence of clinical symptoms and positive laboratory results. Infection rates will be measured on the unit level. Infection rate will be (# of CDI/patient days)'}, {'measure': 'MRSA (HAI) Rates', 'timeFrame': 'monthly, up to 18 months', 'description': 'The rates of healthcare-associated methicillin-resistant Staphylococcus aureus (MRSA) infection will be measured as (# of MRSA cases/patient days) on the unit level.'}, {'measure': 'CLABSI (HAI) Rates', 'timeFrame': 'monthly, up to 18 months', 'description': 'The rates of healthcare-associated central line-associated bloodstream infection (CLABSI) will be measured as (# of CLABSI cases per number of device days) on the unit level.'}, {'measure': 'CAUTI (HAI) Rates', 'timeFrame': 'monthly, up to 18 months', 'description': 'The rates of healthcare-associated catheter-associated urinary tract infection (CAUTI) will be measured as (# of CAUTI cases per number of device days) on the unit level.'}, {'measure': 'Intervention Fidelity - Barrier Precaution Compliance', 'timeFrame': 'monthly, up to 18 months', 'description': 'Healthcare worker barrier precaution compliance with unit-wide gloving practices during patient care activities will be measured via observations in participating units. Compliance will be measured as a percentage of use of appropriate gloving practices per opportunities for gloving practices.'}, {'measure': '30-day Mortality', 'timeFrame': 'during hospitalization, up to one month', 'description': 'Mortality will be defined as the number of patients who die per the number of patient days at risk during study period. Mortality rate will be (# of deaths/patient days)'}, {'measure': 'Length of Stay', 'timeFrame': 'during hospitalization, approximately 5 days', 'description': 'the average number of days spent in the participating unit based on unit admission and unit discharge dates'}, {'measure': 'HAI Costs', 'timeFrame': 'through study completion, an average of 18 months', 'description': 'total costs in U.S. dollars attributed to the number of HAIs during study period'}, {'measure': 'Supply Costs', 'timeFrame': 'through study completion, an average of 18 months', 'description': 'total costs in U.S. dollars attributed to the number of gloves used during study period'}, {'measure': 'Patient and Healthcare Worker Experience', 'timeFrame': 'months 12 - 18', 'description': 'Qualitative data describing the patient and healthcare worker experience with the intervention of universal gloving.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clostridium difficile', 'Barrier Precautions', 'Personal Protective Equipment'], 'conditions': ['Clostridium Difficile']}, 'descriptionModule': {'briefSummary': 'Clostridium difficile (C. difficile) is a major pathogen causing serious healthcare-associated diarrheal illness in patients. Prevention of healthcare facility-onset C. difficile infection (CDI) is essential. Many CDI cases are caused by the transmission of the pathogen from patients who carry the bacteria, but do not have symptoms. However, there are limited data on how to prevent the transmission of C. difficile from patients who do not have symptoms. Universal gloving practices - the use of gloves by all healthcare workers for all patient contacts - may reduce CDI cases. In this study, the investigators will examine the effectiveness of universal gloving practices as compared to standard of care (use of gloving for contact only in patients with known CDI or other infections). The investigators will compare the effects of these practices on the transmission of C. difficile within participating hospital units to determine if universal gloving is an effective practice to prevent healthcare-associated CDI.', 'detailedDescription': 'Background: Clostridium difficile infection (CDI) has become the most common healthcare-associated infection (HAI) in US hospitals, causing approximately 500,000 infections and 30,000 deaths per year. Prevention of healthcare-onset (HO) CDI has quickly become a priority for many hospitals. Hospital prevention measures are limited to modifiable risk factors (i.e., prudent antibiotic use and limiting exposure to C. difficile). Hospital exposure to C. difficile can occur directly (i.e., hands or clothing of healthcare workers) or indirectly (i.e., environmental surfaces or shared equipment), so infection prevention measures focus on healthcare worker hand hygiene, barrier precautions (use of gowns and gloves) and cleaning of the hospital environment and reusable medical equipment. However, these interventions are limited to symptomatic patients who test positive for CDI. Asymptomatic patients serve as a reservoir for cross-contamination, but microbiological screening for asymptomatic carriage of C. difficile is not routinely performed in healthcare. Gloving for all patient contacts may interrupt transmission from asymptomatic patients colonized with C. difficile.\n\nObjectives: The overall purpose of the study is to determine the effectiveness of healthcare worker use of gloves for all patient contact (universal gloving) on reducing acquisition of C. difficile and hospital-onset CDI in inpatient hospital units. The main objective of the study is to compare the effects of universal gloving for all patient contact to the current standard of care (i.e., glove and gown use only for known CDI cases). The specific aims are: 1) compare the effects of universal gloving for all patient contact to the current standard of care on C. difficile acquisition rates in hospitalized patients; 2) compare the effects of universal gloving compared to standard of care on CDI rates, other HAI rates, 30-day mortality, and unit length of stay; and 3) evaluate intervention fidelity, cost, and stakeholder experiences with universal gloving.\n\nMethods: The study will be a cluster randomized trial (CRT) in ten inpatient VA hospital units. Hospital units will be randomized either to implement universal gloving intervention or to continue standard of care. The universal gloving intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing gloves for all patient contacts in the units that are randomized to receive the intervention. The non-intervention units will follow standard of care which consists of healthcare workers using gowns and gloves only for patients with known CDI and other infections (e.g., MRSA). Unit-level data will be collected, including C. difficile acquisition and infection rates, mortality, length of stay, barrier precaution compliance, and end-user perceptions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nVA inpatient units meeting the following criteria are eligible to participate in the study:\n\n* Ability to identify one of the following inpatient units as defined by Centers for Disease Control (CDC) National Healthcare Safety Network30 by reviewing prior 12-month patient mix data (at least 80% of patients meet patient type):\n\n * Adult Acute Medical Ward: Hospital area for the evaluation and treatment of patients with medical conditions or disorders.\n * Adult Acute Medical/Surgical Ward: Hospital area for the evaluation of patients with medical and/or surgical conditions.\n * Adult Acute Surgical Ward: Hospital area for evaluation and treatment of patients who have undergone a surgical procedure.\n* Ability to collect and upload data (HAIs, mortality, length of stay, hand hygiene and barrier precaution compliance; glove use and glove plus gown use for contact precautions) required for analysis.\n* Local R\\&D Committee approval.\n* Letter of support from the Hospital Director or Chief of Staff.\n* Ability to enroll one unit to intervention and one unit to control.\n\nTo participate in interviews or focus groups, the individual must be:\n\n* 18 years of age or older\n* A patient admitted to the participating unit OR a healthcare worker who has regular work duties on the participating unit.\n\nExclusion Criteria:\n\n* Intensive care units\n* Long term care units'}, 'identificationModule': {'nctId': 'NCT04036058', 'acronym': 'GLORI', 'briefTitle': 'Effect of Expanding (Gloving) Barrier Precautions for Reducing Clostridium Difficile Acquisition (and Infection) in VA', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Effect of Expanding Barrier Precautions for Reducing Clostridium Difficile Acquisition in VA', 'orgStudyIdInfo': {'id': 'IIR 18-087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Enact universal gloving practices', 'interventionNames': ['Other: Universal gloving']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Continue standard of care gloving practices'}], 'interventions': [{'name': 'Universal gloving', 'type': 'OTHER', 'otherNames': ['Expanded barrier precautions'], 'description': 'The intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing universal gloving (non-sterile gloves) for all patient contacts in the units that are randomized to receive the intervention. If a patient in the intervention unit is known to have CDI or a multidrug-resistant organisms, both gowns and gloves will be used as is currently recommended. Signage denoting what type of precautions are needed will be utilized.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20422-0001', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington DC VA Medical Center, Washington, DC', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60141-3030', 'city': 'Hines', 'state': 'Illinois', 'country': 'United States', 'facility': 'Edward Hines Jr. VA Hospital, Hines, IL', 'geoPoint': {'lat': 41.85364, 'lon': -87.8395}}, {'zip': '10468-3904', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'James J. Peters VA Medical Center, Bronx, NY', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '97207-2964', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'VA Portland Health Care System, Portland, OR', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '53705-2254', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'William S. Middleton Memorial Veterans Hospital, Madison, WI', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53295-0001', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Clement J. Zablocki VA Medical Center, Milwaukee, WI', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Nasia Safdar, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, WI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}