Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

13952 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-03

Study Completion Date

2023-10-10

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.

Detailed Description

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Conditions

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Hospitalization Infection

Keywords

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Nursing Homes Health Facilities Infections Readmissions Multi-Drug resistance Antibiotic Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Decolonization

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

Group Type ACTIVE_COMPARATOR

Chlorhexidine gluconate (CHG)

Intervention Type DRUG

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)

Intervention Type DRUG

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.

Routine Bathing

Routine bathing per facility protocol.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Susan Huang

Professor and Medical Director of Epidemiology and Infection Prevention

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan Huang, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Loren Miller, MD MPH

Role: STUDY_DIRECTOR

Harbor UCLA

James McKinnell, MD

Role: STUDY_DIRECTOR

Harbor UCLA

Locations

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Buena Vista Care Center

Anaheim, California, United States

Site Status

Walnut Village Rehabilitation and Care Center

Anaheim, California, United States

Site Status

Anaheim Crest Nursing Center

Anaheim, California, United States

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Sun Mar Nursing Center

Anaheim, California, United States

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West Anaheim Extended Care

Anaheim, California, United States

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Bel Tooren Villa Convalescent Hospital

Bellflower, California, United States

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Capistrano Beach Care Center

Capistrano Beach, California, United States

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Downey Care Center

Downey, California, United States

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Gordon Lane Care Center

Fullerton, California, United States

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Windsor Gardens Care Center of Fullerton

Fullerton, California, United States

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Terrace View Care Center

Fullerton, California, United States

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Pacific Haven Subacute Healthcare Center

Garden Grove, California, United States

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Las Flores Convalescent Hospital

Gardena, California, United States

Site Status