Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization

NCT03118232 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20151805
• Study Type: interventional
• Target: 13,952
• Locations: 1 country
• Sites: 28

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.

Conditions

Hospitalization; Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hospital Transfers Due to Infection

  Probability that a transfer to a hospital is due to an infection

  18 months

Secondary Outcomes (1)

• All Hospital Transfers

  18 months

Other Outcomes (4)

• Multidrug-resistant Organism (MDRO) Colonization (Secondary Manuscript)

  Once in baseline and once at end-intervention (month 15-18 of intervention period)

• Hospital Transfers Due to Infection in Long Stay and Short Stay Subsets (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017)

  18 months

• All Hospital Transfers in Long Stay and Short Stay Subsets (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017)

  18 months

Study Arms (2)

Decolonization

ACTIVE COMPARATOR

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

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

Routine Bathing

NO INTERVENTION

Routine bathing per facility protocol.

Interventions

Chlorhexidine gluconate (CHG) 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.

Decolonization

Iodophor (10% povidone-iodine) 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.

Decolonization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: collaborator
• University of Massachusetts, Amherst: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (28)

Buena Vista Care Center

Anaheim, California, 92802, United States

Location

Walnut Village Rehabilitation and Care Center

Anaheim, California, 92802, United States

Location

Anaheim Crest Nursing Center

Anaheim, California, 92804, United States

Location

Sun Mar Nursing Center

Anaheim, California, 92804, United States

Location

West Anaheim Extended Care

Anaheim, California, 92804, United States

Location

Bel Tooren Villa Convalescent Hospital

Bellflower, California, 90706, United States

Location

Capistrano Beach Care Center

Capistrano Beach, California, 92624, United States

Location

Downey Care Center

Downey, California, 90242, United States

Location

Gordon Lane Care Center

Fullerton, California, 92831, United States

Location

Windsor Gardens Care Center of Fullerton

Fullerton, California, 92832, United States

Location

Terrace View Care Center

Fullerton, California, 92835, United States

Location

Pacific Haven Subacute Healthcare Center

Garden Grove, California, 92843, United States

Location

Las Flores Convalescent Hospital

Gardena, California, 90249, United States

Location

Park Regency Care Center

La Habra, California, 90631, United States

Location

Regency Oaks Post Acute Care Center

Long Beach, California, 90804, United States

Location

Windsor Convalescent of North Long Beach

Long Beach, California, 90805, United States

Location

Bixby Knolls Healthcare Center

Long Beach, California, 90807, United States

Location

Pacific Villa Inc.

Long Beach, California, 90807, United States

Location

Vista Cove Care Center at Long Beach

Long Beach, California, 90807, United States

Location

Intercommunity Care Center

Long Beach, California, 90815, United States

Location

Royal Oaks Care Center

Lynwood, California, 90262, United States

Location

Norwalk Skilled Nursing and Wellness Center

Norwalk, California, 90650, United States

Location

Villa Elena Care Center

Norwalk, California, 90650, United States

Location

Harbor Post-Acute Care Center

Torrance, California, 90502, United States

Location

Heritage Rehabilitation Center

Torrance, California, 90502, United States

Location

Sunnyside Nursing Center

Torrance, California, 90502, United States

Location

Torrance Care Center West

Torrance, California, 90503, United States

Location

Del Amo Gardens Care Center

Torrance, California, 90505, United States

Location

Related Publications (1)

• Miller LG, McKinnell JA, Singh RD, Gussin GM, Kleinman K, Saavedra R, Mendez J, Catuna TD, Felix J, Chang J, Heim L, Franco R, Tjoa T, Stone ND, Steinberg K, Beecham N, Montgomery J, Walters D, Park S, Tam S, Gohil SK, Robinson PA, Estevez M, Lewis B, Shimabukuro JA, Tchakalian G, Miner A, Torres C, Evans KD, Bittencourt CE, He J, Lee E, Nedelcu C, Lu J, Agrawal S, Sturdevant SG, Peterson E, Huang SS. Decolonization in Nursing Homes to Prevent Infection and Hospitalization. N Engl J Med. 2023 Nov 9;389(19):1766-1777. doi: 10.1056/NEJMoa2215254. Epub 2023 Oct 10.

  PMID: 37815935 DERIVED

MeSH Terms

Conditions

Infections

Interventions

chlorhexidine gluconate; Iodophors; Povidone-Iodine

Intervention Hierarchy (Ancestors)

Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Susan Huang
• Organization: University of California, Irvine

sshuang@hs.uci.edu

714-456-5047

Study Officials

• Susan Huang, MD MPH

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

• Loren Miller, MD MPH

  Harbor UCLA

  STUDY DIRECTOR

• James McKinnell, MD

  Harbor UCLA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Medical Director of Epidemiology and Infection Prevention

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: April 18, 2017
• Study Start: April 3, 2017
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: December 27, 2023
• Results First Posted: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (28)