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

Clostridium Difficile Clinical Trial

— GLORI  

Official title:

Effect of Expanding Barrier Precautions for Reducing Clostridium Difficile Acquisition in VA

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04036058
• Other study ID #: IIR 18-087
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 29, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Objectives: 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.

Methods: 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: September 30, 2024
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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 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:

• 18 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.

Exclusion Criteria:

• Intensive care units

• Long term care units

Related Conditions & MeSH terms

• Clostridium Difficile
• Clostridium Infections

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center, Bronx, NY	Bronx	New York
United States	Edward Hines Jr. VA Hospital, Hines, IL	Hines	Illinois
United States	William S. Middleton Memorial Veterans Hospital, Madison, WI	Madison	Wisconsin
United States	Clement J. Zablocki VA Medical Center, Milwaukee, WI	Milwaukee	Wisconsin
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon
United States	Washington DC VA Medical Center, Washington, DC	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	12 months
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)	12 months
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.	12 months
Secondary	30-day mortality rate	Patients' average 30-day mortality (percentage of patients that died within 30 days after unit admission date) will be measured on the unit level.	12 months
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.	12 months
Secondary	Length of stay	Patient's average length of stay (number of days spent in the hospital based on unit admission and discharge) will be measured on the unit level.	12 months
Secondary	HAI Cost	Estimated costs of burden caused by healthcare-associated infections based on published reports	12 months
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.	12 months
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.	12 months
Secondary	Patient and Healthcare Worker Experience	Qualitative interviews of patients and healthcare workers evalutaing their experience with the intervention; universal gloving	12 months
Secondary	Supply Costs	Estimated based on glove use data, collected from a monthly list of supplies (i.e. gloves) issued to each unit (both control and intervention arms) from their distribution departments.	12 months