Clostridium Difficile
Conditions
Keywords
Clostridium difficile, Barrier Precautions, Personal Protective Equipment
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.
Interventions
OTHERUniversal 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.
Sponsors
University of Wisconsin, Madison
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C. Difficile Acquisition Rates | during hospitalization, approximately 5 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MRSA (HAI) Rates | monthly, up to 18 months | The rates of healthcare-associated methicillin-resistant Staphylococcus aureus (MRSA) infection will be measured as (# of MRSA cases/patient days) on the unit level. |
| CLABSI (HAI) Rates | monthly, up to 18 months | 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. |
| CAUTI (HAI) Rates | monthly, up to 18 months | 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. |
| Intervention Fidelity - Barrier Precaution Compliance | monthly, up to 18 months | 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. |
| Hospital-onset C. Difficile Infection (HO-CDI) Rates | monthly, up to 18 months | 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) |
| Length of Stay | during hospitalization, approximately 5 days | the average number of days spent in the participating unit based on unit admission and unit discharge dates |
| HAI Costs | through study completion, an average of 18 months | total costs in U.S. dollars attributed to the number of HAIs during study period |
| Supply Costs | through study completion, an average of 18 months | total costs in U.S. dollars attributed to the number of gloves used during study period |
| Patient and Healthcare Worker Experience | months 12 - 18 | Qualitative data describing the patient and healthcare worker experience with the intervention of universal gloving. |
| 30-day Mortality | during hospitalization, up to one month | Mortality will be defined as the number of patients who die per the number of patient days at risk during study period. Mortality rate will be (# of deaths/patient days) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Enact universal gloving practices
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. | 450 |
| Intervention Enact universal gloving practices
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. | 5 |
| Control Continue standard of care gloving practices | 298 |
| Control Continue standard of care gloving practices | 5 |
| Total | 758 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 72 years | 71 years | 70 years |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 9 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 91 Participants | 222 Participants | 131 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 45 Participants | 31 Participants |
| Race (NIH/OMB) White | 185 Participants | 463 Participants | 278 Participants |
| Sex: Female, Male Female | 15 Participants | 58 Participants | 43 Participants |
| Sex: Female, Male Male | 283 Participants | 690 Participants | 407 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 28 / 470 | 26 / 310 |
| other Total, other adverse events | 0 / 470 | 0 / 310 |
| serious Total, serious adverse events | 0 / 470 | 0 / 310 |
Outcome results
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)
Time frame: during hospitalization, approximately 5 days
Population: The intervention group had 5569 patient admissions in 5 participating units with 988 patient days of care; 303 subjects had both admission and discharge specimens with 13 that acquired c. difficile (c. difficile negative upon admission and positive upon discharge). The control group had 4412 patient admissions in 5 participating units with 674 patient days of care; 171 subjects had both admission and discharge specimens with 7 that acquired c. difficile.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | C. Difficile Acquisition Rates | 13.2 C. diff acquisition per patient days |
| Control | C. Difficile Acquisition Rates | 10.4 C. diff acquisition per patient days |
p-value: 0.611t-test, 2 sided
Secondary
30-day Mortality
Mortality will be defined as the number of patients who die per the number of patient days at risk during study period. Mortality rate will be (# of deaths/patient days)
Time frame: during hospitalization, up to one month
Population: participants that are reported in the Participant Flow differ from the baseline analysis population due to missing mortality data
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | 30-day Mortality | 28.3 patient deaths per patient admission |
| Control | 30-day Mortality | 38.6 patient deaths per patient admission |
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.
Time frame: monthly, up to 18 months
Population: The intervention group had 5569 patient admissions in 5 participating units with 4807 catheter days of care; 0 subjects developed CAUTI. The control group had 4412 patient admissions in 5 participating units with 5763 catheter days of care; 3 subjects developed CAUTI.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | CAUTI (HAI) Rates | 0.00 CAUTI per foley catheter days |
| Control | CAUTI (HAI) Rates | 0.5206 CAUTI per foley catheter days |
p-value: 0.114t-test, 2 sided
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.
Time frame: monthly, up to 18 months
Population: The intervention group had 5569 patient admissions in 5 participating units with 4846 line days of care; 5 subjects developed CLABSI. The control group had 4412 patient admissions in 5 participating units with 5100 line days of care; 1 subjects developed CLABSI.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | CLABSI (HAI) Rates | 1.0318 CLABSI per central line days |
| Control | CLABSI (HAI) Rates | 0.1961 CLABSI per central line days |
p-value: 0.0898t-test, 2 sided
Secondary
HAI Costs
total costs in U.S. dollars attributed to the number of HAIs during study period
Time frame: through study completion, an average of 18 months
Population: Overall Number of Participants Analyzed is inconsistent with the total number of participants reported in the Participant Flow module because we used unit-level aggregate data rather than participant-level data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | HAI Costs | 155349 U.S. dollars |
| Control | HAI Costs | 362460 U.S. dollars |
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)
Time frame: monthly, up to 18 months
Population: In the intervention group there were 5369 patient admitted in the 5 participating inpatient hospital units with 37842 patient days of care. The intervention group had 5569 patient admissions in 5 participating units with 37842 patient days of care; 9 subjects developed CDI. The control group had 4412 patient admissions in 5 participating units with 40310 patient days of care; 21 subjects developed CDI.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Hospital-onset C. Difficile Infection (HO-CDI) Rates | 0.2379 CDI per patient days |
| Control | Hospital-onset C. Difficile Infection (HO-CDI) Rates | 0.5210 CDI per patient days |
p-value: 0.0435t-test, 2 sided
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.
Time frame: monthly, up to 18 months
Population: This population represents healthcare worker glove compliance (intervention fidelity) rather than patient participant data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Intervention Fidelity - Barrier Precaution Compliance | 0.651 glove compliance per glove observations |
Secondary
Length of Stay
the average number of days spent in the participating unit based on unit admission and unit discharge dates
Time frame: during hospitalization, approximately 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Length of Stay | 3.2 days | Standard Error 0.295 |
| Control | Length of Stay | 3.6 days | Standard Error 0.77 |
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.
Time frame: monthly, up to 18 months
Population: The control had 4412 admissions in 5 units with 40310 patient days; 7 subjects developed MRSA.~The intervention group had 5369 patient admissions in 5 participating units with 37843 patient days of care; 2 subjects developed MRSA. The control group had 4412 patient admissions in 5 participating units with 40310 patient days of care; 7 subjects developed MRSA.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | MRSA (HAI) Rates | 0.0528 MRSA per patient days |
| Control | MRSA (HAI) Rates | 0.1737 MRSA per patient days |
p-value: 0.1158t-test, 2 sided
Secondary
Patient and Healthcare Worker Experience
Qualitative data describing the patient and healthcare worker experience with the intervention of universal gloving.
Time frame: months 12 - 18
Population: there were 15 patient interviews and 23 employee interviews but thematic quantitative analysis was not conducted for employee interviews.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Patient and Healthcare Worker Experience | patient perceived no change in care | 10 participants |
| Intervention | Patient and Healthcare Worker Experience | patient perceived no change in hcw hand hygiene | 10 participants |
| Intervention | Patient and Healthcare Worker Experience | patient perceived no change in hcw work activities | 10 participants |
Secondary
Supply Costs
total costs in U.S. dollars attributed to the number of gloves used during study period
Time frame: through study completion, an average of 18 months
Population: Overall Number of Participants Analyzed is inconsistent with the total number of participants reported in the Participant Flow module because we used unit-level aggregate data rather than participant-level data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Supply Costs | 42883 U.S. dollars |