N/A
N=780
Effect of Expanding (Gloving) Barrier Precautions for Reducing Clostridium Difficile Acquisition (and Infection) in VA
Clostridium Difficile
Bottom Line
View on ClinicalTrials.gov: NCT04036058 ↗Enrolled (actual)
780
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: C. Difficile Acquisition Rates — 13.2; 10.4 C. diff acquisition per patient days — p=0.611
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Universal gloving (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY C. Difficile Acquisition Rates |
13.2; 10.4 | 0.611 |
| SECONDARY Hospital-onset C. Difficile Infection (HO-CDI) Rates |
0.2379; 0.5210 | 0.0435 sig |
| SECONDARY MRSA (HAI) Rates |
0.0528; 0.1737 | 0.1158 |
| SECONDARY CLABSI (HAI) Rates |
1.0318; 0.1961 | 0.0898 |
| SECONDARY CAUTI (HAI) Rates |
0.00; 0.5206 | 0.114 |
| SECONDARY Intervention Fidelity - Barrier Precaution Compliance |
0.651 | — |
| SECONDARY 30-day Mortality |
28.3; 38.6 | — |
| SECONDARY Length of Stay |
3.2; 3.6 | — |
| SECONDARY HAI Costs |
155349; 362460 | — |
| SECONDARY Supply Costs |
42883 | — |
| SECONDARY Patient and Healthcare Worker Experience |
10; 10; 10 | — |
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.
Eligibility Criteria
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 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:
- 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
Data sourced from ClinicalTrials.gov (NCT04036058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.