Trial Outcomes & Findings for Effect of Expanding (Gloving) Barrier Precautions for Reducing Clostridium Difficile Acquisition (and Infection) in VA (NCT NCT04036058)

NCT ID: NCT04036058

Last Updated: 2025-07-11

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 780 participants
• Primary outcome timeframe: during hospitalization, approximately 5 days
• Results posted on: 2025-07-11

Participant Flow

Unit of analysis: inpatient hospital units

Participant milestones

Measure	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.	Control Continue standard of care gloving practices
Overall Study STARTED	470 5	310 5
Overall Study COMPLETED	303 5	171 5
Overall Study NOT COMPLETED	167 0	139 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Expanding (Gloving) Barrier Precautions for Reducing Clostridium Difficile Acquisition (and Infection) in VA

Baseline characteristics by cohort

Measure	Intervention n=5 inpatient hospital units 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.	Control n=5 inpatient hospital units Continue standard of care gloving practices	Total n=10 inpatient hospital units Total of all reporting groups
Age, Continuous	70 years n=5 Participants	72 years n=7 Participants	71 years n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	15 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	407 Participants n=5 Participants	283 Participants n=7 Participants	690 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Black or African American	131 Participants n=5 Participants	91 Participants n=7 Participants	222 Participants n=5 Participants
Race (NIH/OMB) White	278 Participants n=5 Participants	185 Participants n=7 Participants	463 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	31 Participants n=5 Participants	14 Participants n=7 Participants	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: during hospitalization, approximately 5 days

Population: 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.

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)

Outcome measures

Measure	Intervention n=988 patient days of care 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.	Control n=674 patient days of care Continue standard of care gloving practices
C. Difficile Acquisition Rates	13.2 C. diff acquisition per patient days Interval 6.1 to 20.3	10.4 C. diff acquisition per patient days Interval 2.7 to 18.0

SECONDARY outcome

Timeframe: monthly, up to 18 months

Population: 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.

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)

Outcome measures

Measure	Intervention n=37842 patient days of care 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.	Control n=40310 patient days of care Continue standard of care gloving practices
Hospital-onset C. Difficile Infection (HO-CDI) Rates	0.2379 CDI per patient days Interval 0.0825 to 0.3932	0.5210 CDI per patient days Interval 0.2982 to 0.7437

SECONDARY outcome

Timeframe: monthly, up to 18 months

Population: 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.

The rates of healthcare-associated methicillin-resistant Staphylococcus aureus (MRSA) infection will be measured as (# of MRSA cases/patient days) on the unit level.

Outcome measures

Measure	Intervention n=37843 patient days of care 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.	Control n=40310 patient days of care Continue standard of care gloving practices
MRSA (HAI) Rates	0.0528 MRSA per patient days Interval -0.0204 to 0.1261	0.1737 MRSA per patient days Interval 0.045 to 0.3022

SECONDARY outcome

Timeframe: monthly, up to 18 months

Population: 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.

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.

Outcome measures

Measure	Intervention n=4846 line days of care 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.	Control n=5100 line days of care Continue standard of care gloving practices
CLABSI (HAI) Rates	1.0318 CLABSI per central line days Interval 0.1279 to 1.9357	0.1961 CLABSI per central line days Interval -0.1882 to 0.5804

SECONDARY outcome

Timeframe: monthly, up to 18 months

Population: 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.

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.

Outcome measures

Measure	Intervention n=4807 catheter days of care 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.	Control n=5763 catheter days of care Continue standard of care gloving practices
CAUTI (HAI) Rates	0.00 CAUTI per foley catheter days Interval 0.0 to 0.0	0.5206 CAUTI per foley catheter days Interval -0.0684 to 1.1095

SECONDARY outcome

Timeframe: monthly, up to 18 months

Population: This population represents healthcare worker glove compliance (intervention fidelity) rather than patient participant data.

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.

Outcome measures

Measure	Intervention n=5 inpatient hospital units 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.	Control Continue standard of care gloving practices
Intervention Fidelity - Barrier Precaution Compliance	0.651 glove compliance per glove observations Interval 0.616 to 0.686	—

SECONDARY outcome

Timeframe: during hospitalization, up to one month

Population: participants that are reported in the Participant Flow differ from the baseline analysis population due to missing mortality data

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)

Outcome measures

Measure	Intervention n=5 inpatient hospital units 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.	Control n=5 inpatient hospital units Continue standard of care gloving practices
30-day Mortality	28.3 patient deaths per patient admission Interval 18.0 to 38.7	38.6 patient deaths per patient admission Interval 24.0 to 53.1

SECONDARY outcome

Timeframe: during hospitalization, approximately 5 days

the average number of days spent in the participating unit based on unit admission and unit discharge dates

Outcome measures

Measure	Intervention n=5 inpatient hospital units 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.	Control n=5 inpatient hospital units Continue standard of care gloving practices
Length of Stay	3.2 days Standard Error 0.295	3.6 days Standard Error 0.770

SECONDARY outcome

Timeframe: through study completion, an average of 18 months

Population: 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.

total costs in U.S. dollars attributed to the number of HAIs during study period

Outcome measures

Measure	Intervention n=5 inpatient hospital units 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.	Control n=5 inpatient hospital units Continue standard of care gloving practices
HAI Costs	155349 U.S. dollars	362460 U.S. dollars

SECONDARY outcome

Timeframe: through study completion, an average of 18 months

Population: 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.

total costs in U.S. dollars attributed to the number of gloves used during study period

Outcome measures

Measure	Intervention n=5 inpatient hospital units 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.	Control Continue standard of care gloving practices
Supply Costs	42883 U.S. dollars	—

SECONDARY outcome

Timeframe: months 12 - 18

Population: there were 15 patient interviews and 23 employee interviews but thematic quantitative analysis was not conducted for employee interviews.

Qualitative data describing the patient and healthcare worker experience with the intervention of universal gloving.

Outcome measures

Measure	Intervention n=15 Participants 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.	Control Continue standard of care gloving practices
Patient and Healthcare Worker Experience patient perceived no change in care	10 participants	—
Patient and Healthcare Worker Experience patient perceived no change in hcw hand hygiene	10 participants	—
Patient and Healthcare Worker Experience patient perceived no change in hcw work activities	10 participants	—

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 28 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 26 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Linda McKinley

Wm. S. Middleton Memorial VA Hospital

Phone: 608-256-1901

Email: linda.mckinley2@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place