| Primary | C. Difficile Acquisition Rates | 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) | 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. | Posted | | Mean | 95% Confidence Interval | C. diff acquisition per patient days | | during hospitalization, approximately 5 days | patient days of care | patient days of care | | ID | Title | Description |
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| OG000 | Intervention | Enact universal gloving practices Universal 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. | | OG001 | Control | Continue standard of care gloving practices |
| | Units | Counts |
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| Participants | | | patient days of care | |
| | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00013.2(6.1 to 20.3)
- OG00110.4(2.7 to 18.0)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | t-test, 2 sided | | 0.611 | | | | | | | | | | | | | | Superiority | | |
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| Secondary | Hospital-onset C. Difficile Infection (HO-CDI) Rates | 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) | 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. | Posted | | Mean | 95% Confidence Interval | CDI per patient days | | monthly, up to 18 months | patient days of care | patient days of care | | ID | Title | Description |
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| OG000 | Intervention | Enact universal gloving practices Universal 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. | | OG001 | Control | Continue standard of care gloving practices |
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| Secondary | MRSA (HAI) Rates | The rates of healthcare-associated methicillin-resistant Staphylococcus aureus (MRSA) infection will be measured as (# of MRSA cases/patient days) on the unit level. | The control had 4412 admissions in 5 units with 40310 patient days; 7 subjects developed MRSA. The 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. | Posted | | Mean | 95% Confidence Interval | MRSA per patient days | | monthly, up to 18 months | patient days of care | patient days of care | | ID | Title | Description |
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| OG000 | Intervention | Enact universal gloving practices Universal 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. | | OG001 | Control | Continue standard of care gloving practices |
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| Secondary | CLABSI (HAI) Rates | 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. | 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. | Posted | | Mean | 95% Confidence Interval | CLABSI per central line days | | monthly, up to 18 months | line days of care | line days of care | | ID | Title | Description |
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| OG000 | Intervention | Enact universal gloving practices Universal 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. | | OG001 | Control | Continue standard of care gloving practices |
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| Secondary | CAUTI (HAI) Rates | 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. | 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. | Posted | | Mean | 95% Confidence Interval | CAUTI per foley catheter days | | monthly, up to 18 months | catheter days of care | catheter days of care | | ID | Title | Description |
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| OG000 | Intervention | Enact universal gloving practices Universal 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. | | OG001 | Control | Continue standard of care gloving practices |
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| Secondary | Intervention Fidelity - Barrier Precaution Compliance | 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. | This population represents healthcare worker glove compliance (intervention fidelity) rather than patient participant data. | Posted | | Mean | 95% Confidence Interval | glove compliance per glove observations | | monthly, up to 18 months | inpatient hospital units | inpatient hospital units | | ID | Title | Description |
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| OG000 | Intervention | Enact universal gloving practices Universal 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. |
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| Secondary | 30-day Mortality | 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) | participants that are reported in the Participant Flow differ from the baseline analysis population due to missing mortality data | Posted | | Mean | 95% Confidence Interval | patient deaths per patient admission | | during hospitalization, up to one month | inpatient hospital units | inpatient hospital units | | ID | Title | Description |
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| OG000 | Intervention | Enact universal gloving practices Universal 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. | | OG001 | Control | Continue standard of care gloving practices |
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| Secondary | Length of Stay | the average number of days spent in the participating unit based on unit admission and unit discharge dates | | Posted | | Mean | Standard Error | days | | during hospitalization, approximately 5 days | inpatient hospital units | inpatient hospital units | | ID | Title | Description |
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| OG000 | Intervention | Enact universal gloving practices Universal 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. | | OG001 | Control | Continue standard of care gloving practices |
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| Secondary | HAI Costs | total costs in U.S. dollars attributed to the number of HAIs during study period | 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. | Posted | | Number | | U.S. dollars | | through study completion, an average of 18 months | inpatient hospital units | inpatient hospital units | | ID | Title | Description |
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| OG000 | Intervention | Enact universal gloving practices Universal 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. | | OG001 | Control | Continue standard of care gloving practices |
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| Secondary | Supply Costs | total costs in U.S. dollars attributed to the number of gloves used during study period | 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. | Posted | | Number | | U.S. dollars | | through study completion, an average of 18 months | inpatient hospital units | inpatient hospital units | | ID | Title | Description |
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| OG000 | Intervention | Enact universal gloving practices Universal 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. |
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| Secondary | Patient and Healthcare Worker Experience | Qualitative data describing the patient and healthcare worker experience with the intervention of universal gloving. | there were 15 patient interviews and 23 employee interviews but thematic quantitative analysis was not conducted for employee interviews. | Posted | | Number | | participants | | months 12 - 18 | | | | ID | Title | Description |
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| OG000 | Intervention | Enact universal gloving practices Universal 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. |
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