Hospitalization, Infection
Conditions
Keywords
Nursing Homes, Health Facilities, Infections, Readmissions, Multi-Drug resistance, Antibiotic Use
Brief summary
This is a cluster-randomized trial of nursing homes to assess whether decolonization with routine chlorhexidine bathing and periodic use of nasal antiseptics can reduce hospitalizations associated with infections, antibiotic utilization, and multi-drug resistant organism (MDRO) prevalence. The comparator arm will be routine bathing care.
Interventions
2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.
DRUGIodophor (10% povidone-iodine)
Nasal decolonization using topical 10% povidone-iodine nasal swabs will be applied to all residents on admission for 5 days twice daily plus every other week Monday-Friday using a twice daily regimen.
Sponsors
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
University of Massachusetts, Amherst
Agency for Healthcare Research and Quality (AHRQ)
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Nursing homes will be eligible to participate if they meet the following criteria: * Licensed nursing home in Orange County or Southern Los Angeles County serving adults * Minimal use of chlorhexidine bathing\* * Minimal use of nasal decolonization\* \*Minimal use defined as \<15% of residents receiving at least one chlorhexidine bath or nasal decolonization treatment during their nursing home stay.
Exclusion criteria
Nursing homes will not be eligible to participate if they meet the following criteria: * Facilities routinely using decolonization * Dedicated psychiatric nursing homes * Facilities with a resident population with \>=20% combative patients * Pediatric facilities Note: in any participating nursing home, residents with active end-of-life comfort care only measures are excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Transfers Due to Infection | 18 months | Probability that a transfer to a hospital is due to an infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All Hospital Transfers | 18 months | Probability that a discharge is to a hospital |
Other
| Measure | Time frame | Description |
|---|---|---|
| Multidrug-resistant Organism (MDRO) Colonization (Secondary Manuscript) | Once in baseline and once at end-intervention (month 15-18 of intervention period) | Probability of colonization with any multidrug-resistant organism (MDRO): (MRSA, VRE, ESBL, CRE) |
| Hospital Transfers Due to Infection in Long Stay and Short Stay Subsets (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017) | 18 months | Probability that a transfer to a hospital is due to an infection for long stay and short stay resident subsets |
| All Hospital Transfers in Long Stay and Short Stay Subsets (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017) | 18 months | Probability that a discharge is to a hospital for long stay and short stay resident subsets |
| Emergency Department Transfers Due to Infection (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017) | 18 months | Probability that a resident is sent to the emergency department for an infection, overall for long stay and short stay resident subsets |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Decolonization Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.
Chlorhexidine gluconate (CHG): 2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.
Iodophor (10% povidone-iodine): Nasal decolonization using topical 10% povidone-iodine nasal swabs will be applied to all residents on admission for 5 days twice daily plus every other week Monday-Friday using a twice daily regimen. | 7,388 |
| Routine Bathing Routine bathing per facility protocol. | 6,564 |
| Total | 13,952 |
Baseline characteristics
| Characteristic | Decolonization | Total | Routine Bathing |
|---|---|---|---|
| Age, Continuous | 75.7 years STANDARD_DEVIATION 4.2 | 76.2 years STANDARD_DEVIATION 5 | 76.6 years STANDARD_DEVIATION 5.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1042 Participants | 2354 Participants | 1312 Participants |
| Race (NIH/OMB) Black or African American | 841 Participants | 1883 Participants | 1042 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1756 Participants | 3300 Participants | 1544 Participants |
| Race (NIH/OMB) White | 3749 Participants | 6415 Participants | 2666 Participants |
| Region of Enrollment United States | 7388 Participants | 13952 Participants | 6564 Participants |
| Sex: Female, Male Female | 4180 Participants | 7782 Participants | 3602 Participants |
| Sex: Female, Male Male | 3208 Participants | 6170 Participants | 2962 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7,388 | 0 / 6,564 |
| other Total, other adverse events | 35 / 7,388 | 0 / 6,564 |
| serious Total, serious adverse events | 0 / 7,388 | 0 / 6,564 |
Outcome results
Primary
Hospital Transfers Due to Infection
Probability that a transfer to a hospital is due to an infection
Time frame: 18 months
Population: Analysis is of residents accounting for clustering in 28 nursing homes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decolonization | Hospital Transfers Due to Infection | 1243 Transfers |
| Routine Bathing | Hospital Transfers Due to Infection | 1780 Transfers |
p-value: <0.00195% CI: [11, 21.8]Mixed Models Analysis
Secondary
All Hospital Transfers
Probability that a discharge is to a hospital
Time frame: 18 months
Population: Analysis is of residents accounting for clustering in 28 nursing homes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decolonization | All Hospital Transfers | 2388 Transfers |
| Routine Bathing | All Hospital Transfers | 2857 Transfers |
p-value: <0.00195% CI: [9.7, 19.2]Mixed Models Analysis
Other Pre-specified
All Hospital Transfers in Long Stay and Short Stay Subsets (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017)
Probability that a discharge is to a hospital for long stay and short stay resident subsets
Time frame: 18 months
Other Pre-specified
Emergency Department Transfers Due to Infection (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017)
Probability that a resident is sent to the emergency department for an infection, overall for long stay and short stay resident subsets
Time frame: 18 months
Other Pre-specified
Hospital Transfers Due to Infection in Long Stay and Short Stay Subsets (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017)
Probability that a transfer to a hospital is due to an infection for long stay and short stay resident subsets
Time frame: 18 months
Other Pre-specified
Multidrug-resistant Organism (MDRO) Colonization (Secondary Manuscript)
Probability of colonization with any multidrug-resistant organism (MDRO): (MRSA, VRE, ESBL, CRE)
Time frame: Once in baseline and once at end-intervention (month 15-18 of intervention period)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Decolonization | Multidrug-resistant Organism (MDRO) Colonization (Secondary Manuscript) | 176 Participants |
| Routine Bathing | Multidrug-resistant Organism (MDRO) Colonization (Secondary Manuscript) | 307 Participants |