Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization

Infection Clinical Trial

— PROTECT  

Official title:

Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118232
• Other study ID #: 20151805
• Status: Completed
• Phase: Phase 4
• Start date: April 3, 2017
• Est. completion date: October 10, 2023

Study information

• Verified date: December 2023
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13952
• Est. completion date: October 10, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Hospitalization
• Infection
• Infections

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Anaheim Crest Nursing Center	Anaheim	California
United States	Buena Vista Care Center	Anaheim	California
United States	Sun Mar Nursing Center	Anaheim	California
United States	Walnut Village Rehabilitation and Care Center	Anaheim	California
United States	West Anaheim Extended Care	Anaheim	California
United States	Bel Tooren Villa Convalescent Hospital	Bellflower	California
United States	Capistrano Beach Care Center	Capistrano Beach	California
United States	Downey Care Center	Downey	California
United States	Gordon Lane Care Center	Fullerton	California
United States	Terrace View Care Center	Fullerton	California
United States	Windsor Gardens Care Center of Fullerton	Fullerton	California
United States	Pacific Haven Subacute Healthcare Center	Garden Grove	California
United States	Las Flores Convalescent Hospital	Gardena	California
United States	Park Regency Care Center	La Habra	California
United States	Bixby Knolls Healthcare Center	Long Beach	California
United States	Intercommunity Care Center	Long Beach	California
United States	Pacific Villa Inc.	Long Beach	California
United States	Regency Oaks Post Acute Care Center	Long Beach	California
United States	Vista Cove Care Center at Long Beach	Long Beach	California
United States	Windsor Convalescent of North Long Beach	Long Beach	California
United States	Royal Oaks Care Center	Lynwood	California
United States	Norwalk Skilled Nursing and Wellness Center	Norwalk	California
United States	Villa Elena Care Center	Norwalk	California
United States	Del Amo Gardens Care Center	Torrance	California
United States	Harbor Post-Acute Care Center	Torrance	California
United States	Heritage Rehabilitation Center	Torrance	California
United States	Sunnyside Nursing Center	Torrance	California
United States	Torrance Care Center West	Torrance	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Irvine	Agency for Healthcare Research and Quality (AHRQ), Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, University of Massachusetts, Amherst

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Multidrug-resistant Organism (MDRO) Colonization (Secondary Manuscript)	Probability of colonization with any multidrug-resistant organism (MDRO): (MRSA, VRE, ESBL, CRE)	Once in baseline and once at end-intervention (month 15-18 of intervention period)
Other	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	18 months
Other	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	18 months
Other	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	18 months
Primary	Hospital Transfers Due to Infection	Probability that a transfer to a hospital is due to an infection	18 months
Secondary	All Hospital Transfers	Probability that a discharge is to a hospital	18 months