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

Study Overview
=================
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.

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

Conditions
-----------------
Clostridium Difficile

Intervention / Treatment
-----------------
* Other: Universal gloving


Participation Criteria
=================
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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Enact universal gloving practices | Other: Universal gloving<br>* 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.<br>* Other names: Expanded barrier precautions;|
| No Intervention: Control<br>Continue standard of care gloving practices | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| HAI Cost | Estimated costs of burden caused by healthcare-associated infections based on published reports | 12 months | 
| 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 | 
| 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 | 
| Patient and Healthcare Worker Experience | Qualitative interviews of patients and healthcare workers evalutaing their experience with the intervention; universal gloving | 12 months | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clostridium difficile, Barrier Precautions, Personal Protective Equipment