Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization

University of California Irvine (UCI)

Status and phase: Completed; Phase 4

Conditions: Infection; Hospitalization

Treatments: Drug: Chlorhexidine gluconate (CHG); Drug: Iodophor (10% povidone-iodine)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03118232

20151805

Details and patient eligibility

About

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.

Enrollment: 13,952 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13,952 participants in 2 patient groups

Decolonization

Active Comparator group

Description:

Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.

Treatment:

Drug: Chlorhexidine gluconate (CHG)

Drug: Iodophor (10% povidone-iodine)

Routine Bathing

No Intervention group

Description:

Routine bathing per facility protocol.