Clinical trial NCT03118232: Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization
Official title: Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hospitalization
Infection
Keywords: Nursing Homes
Health Facilities
Infections
Readmissions
Multi-Drug resistance
Antibiotic Use
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
name: University of Massachusetts, Amherst
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2017-04-18
Enrollment: 13952
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Hospital Transfers Due to Infection
timeFrame: 18 months
Secondary outcomes:
measure: All Hospital Transfers
timeFrame: 18 months
Other outcomes:
measure: Multidrug-resistant Organism (MDRO) Colonization (Secondary Manuscript)
timeFrame: Once in baseline and once at end-intervention (month 15-18 of intervention period)
measure: Hospital Transfers Due to Infection in Long Stay and Short Stay Subsets (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017)
timeFrame: 18 months
measure: All Hospital Transfers in Long Stay and Short Stay Subsets (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017)
timeFrame: 18 months
measure: Emergency Department Transfers Due to Infection (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017)
timeFrame: 18 months
Locations:
city: Anaheim
country: United States
facility: Buena Vista Care Center
state: California
city: Anaheim
country: United States
facility: Walnut Village Rehabilitation and Care Center
state: California
city: Anaheim
country: United States
facility: Anaheim Crest Nursing Center
state: California
city: Anaheim
country: United States
facility: Sun Mar Nursing Center
state: California
city: Anaheim
country: United States
facility: West Anaheim Extended Care
state: California
city: Bellflower
country: United States
facility: Bel Tooren Villa Convalescent Hospital
state: California
city: Capistrano Beach
country: United States
facility: Capistrano Beach Care Center
state: California
city: Downey
country: United States
facility: Downey Care Center
state: California
city: Fullerton
country: United States
facility: Gordon Lane Care Center
state: California
city: Fullerton
country: United States
facility: Windsor Gardens Care Center of Fullerton
state: California
city: Fullerton
country: United States
facility: Terrace View Care Center
state: California
city: Garden Grove
country: United States
facility: Pacific Haven Subacute Healthcare Center
state: California
city: Gardena
country: United States
facility: Las Flores Convalescent Hospital
state: California
city: La Habra
country: United States
facility: Park Regency Care Center
state: California
city: Long Beach
country: United States
facility: Regency Oaks Post Acute Care Center
state: California
city: Long Beach
country: United States
facility: Windsor Convalescent of North Long Beach
state: California
city: Long Beach
country: United States
facility: Bixby Knolls Healthcare Center
state: California
city: Long Beach
country: United States
facility: Pacific Villa Inc.
state: California
city: Long Beach
country: United States
facility: Vista Cove Care Center at Long Beach
state: California
city: Long Beach
country: United States
facility: Intercommunity Care Center
state: California
city: Lynwood
country: United States
facility: Royal Oaks Care Center
state: California
city: Norwalk
country: United States
facility: Norwalk Skilled Nursing and Wellness Center
state: California
city: Norwalk
country: United States
facility: Villa Elena Care Center
state: California
city: Torrance
country: United States
facility: Harbor Post-Acute Care Center
state: California
city: Torrance
country: United States
facility: Heritage Rehabilitation Center
state: California
city: Torrance
country: United States
facility: Sunnyside Nursing Center
state: California
city: Torrance
country: United States
facility: Torrance Care Center West
state: California
city: Torrance
country: United States
facility: Del Amo Gardens Care Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Susan Huang, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Harbor UCLA
name: Loren Miller, MD MPH
role: STUDY_DIRECTOR
affiliation: Harbor UCLA
name: James McKinnell, MD
role: STUDY_DIRECTOR
References: