Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization

Study Overview
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Brief Summary
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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.

Official Title
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Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization

Conditions
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Hospitalization, Infection

Intervention / Treatment
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* Drug: Chlorhexidine gluconate (CHG)
* Drug: Iodophor (10% povidone-iodine)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Decolonization<br>Nursing homes assigned to this arm will perform decolonization using topical antiseptic products. | Drug: Chlorhexidine gluconate (CHG)<br>* 2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.<br>Drug: Iodophor (10% povidone-iodine)<br>* 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.<br>|
| No Intervention: Routine Bathing<br>Routine bathing per facility protocol. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Transfers Due to Infection | Probability that a transfer to a hospital is due to an infection | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Hospital Transfers | Probability that a discharge is to a hospital | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nursing Homes, Health Facilities, Infections, Readmissions, Multi-Drug resistance, Antibiotic Use