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:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Effect of Expanding Barrier Precautions for Reducing Clostridium Difficile Acquisition in VA
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GLORI
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: