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

NCT04036058 | Completed Results DMC

• 1 other identifier: IIR 18-087
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Clostridium Difficile

Keywords

Clostridium difficile; Barrier Precautions; Personal Protective Equipment

Outcome Measures

Primary Outcomes (1)

• 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)

  during hospitalization, approximately 5 days

Secondary Outcomes (10)

• Hospital-onset C. Difficile Infection (HO-CDI) Rates

  monthly, up to 18 months

• MRSA (HAI) Rates

  monthly, up to 18 months

• CLABSI (HAI) Rates

  monthly, up to 18 months

• CAUTI (HAI) Rates

  monthly, up to 18 months

• Intervention Fidelity - Barrier Precaution Compliance

  monthly, up to 18 months

Study Arms (2)

Intervention

EXPERIMENTAL

Enact universal gloving practices

Other: Universal gloving

Control

NO INTERVENTION

Continue standard of care gloving practices

Interventions

Universal gloving OTHER

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.

Also known as: Expanded barrier precautions

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• VA inpatient units meeting the following criteria are eligible to participate in the study:
• 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):
• Adult Acute Medical Ward: Hospital area for the evaluation and treatment of patients with medical conditions or disorders.
• Adult Acute Medical/Surgical Ward: Hospital area for the evaluation of patients with medical and/or surgical conditions.
• Adult Acute Surgical Ward: Hospital area for evaluation and treatment of patients who have undergone a surgical procedure.
• 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.
• Local R\&D Committee approval.
• Letter of support from the Hospital Director or Chief of Staff.
• Ability to enroll one unit to intervention and one unit to control.
• To participate in interviews or focus groups, the individual must be:
• years of age or older
• A patient admitted to the participating unit OR a healthcare worker who has regular work duties on the participating unit.

You may not qualify if:

• Intensive care units
• Long term care units

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Wisconsin, Madison: collaborator

Study Sites (6)

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, 20422-0001, United States

Location

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

Location

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

Location

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705-2254, United States

Location

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, 53295-0001, United States

Location

Limitations and Caveats

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.

Results Point of Contact

• Title: Linda McKinley
• Organization: Wm. S. Middleton Memorial VA Hospital

linda.mckinley2@va.gov

608-256-1901

Study Officials

• Nasia Safdar, MD PhD

  William S. Middleton Memorial Veterans Hospital, Madison, WI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 29, 2019
• Study Start: March 29, 2022
• Primary Completion: December 29, 2023
• Study Completion: September 30, 2024
• Last Updated: July 11, 2025
• Results First Posted: July 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)