Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization (PROTECT)

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.

Study Overview

• Status: Completed
• Conditions: Infection; Hospitalization
• Intervention / Treatment: Drug: Chlorhexidine gluconate (CHG); Drug: Iodophor (10% povidone-iodine)

• Study Type: Interventional
• Enrollment (Actual): 13952
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92802
      • Buena Vista Care Center
    • Anaheim, California, United States, 92802
      • Walnut Village Rehabilitation and Care Center
    • Anaheim, California, United States, 92804
      • Anaheim Crest Nursing Center
    • Anaheim, California, United States, 92804
      • Sun Mar Nursing Center
    • Anaheim, California, United States, 92804
      • West Anaheim Extended Care
    • Bellflower, California, United States, 90706
      • Bel Tooren Villa Convalescent Hospital
    • Capistrano Beach, California, United States, 92624
      • Capistrano Beach Care Center
    • Downey, California, United States, 90242
      • Downey Care Center
    • Fullerton, California, United States, 92831
      • Gordon Lane Care Center
    • Fullerton, California, United States, 92832
      • Windsor Gardens Care Center of Fullerton
    • Fullerton, California, United States, 92835
      • Terrace View Care Center
    • Garden Grove, California, United States, 92843
      • Pacific Haven Subacute Healthcare Center
    • Gardena, California, United States, 90249
      • Las Flores Convalescent Hospital
    • La Habra, California, United States, 90631
      • Park Regency Care Center
    • Long Beach, California, United States, 90804
      • Regency Oaks Post Acute Care Center
    • Long Beach, California, United States, 90805
      • Windsor Convalescent of North Long Beach
    • Long Beach, California, United States, 90807
      • Bixby Knolls Healthcare Center
    • Long Beach, California, United States, 90807
      • Pacific Villa Inc.
    • Long Beach, California, United States, 90807
      • Vista Cove Care Center at Long Beach
    • Long Beach, California, United States, 90815
      • Intercommunity Care Center
    • Lynwood, California, United States, 90262
      • Royal Oaks Care Center
    • Norwalk, California, United States, 90650
      • Norwalk Skilled Nursing and Wellness Center
    • Norwalk, California, United States, 90650
      • Villa Elena Care Center
    • Torrance, California, United States, 90502
      • Harbor Post-Acute Care Center
    • Torrance, California, United States, 90502
      • Heritage Rehabilitation Center
    • Torrance, California, United States, 90502
      • Sunnyside Nursing Center
    • Torrance, California, United States, 90503
      • Torrance Care Center West
    • Torrance, California, United States, 90505
      • Del Amo Gardens Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Decolonization; Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.	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.; 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.
No Intervention: Routine Bathing; Routine bathing per facility protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Transfers Due to Infection	Probability that a transfer to a hospital is due to an infection	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Hospital Transfers	Probability that a discharge is to a hospital	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
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

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: University of Massachusetts, Amherst; Agency for Healthcare Research and Quality (AHRQ); Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Investigators: Study Director: Loren Miller, MD MPH, Harbor UCLA; Study Director: James McKinnell, MD, Harbor UCLA; Principal Investigator: Susan Huang, MD MPH, University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2017
• Primary Completion (Actual): October 10, 2023
• Study Completion (Actual): October 10, 2023

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: April 14, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Health Facilities; Infections; Nursing Homes; Readmissions; Antibiotic Use; Multi-Drug resistance
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Plasma Substitutes; Blood Substitutes; Chlorhexidine; Povidone-Iodine; Povidone; Chlorhexidine gluconate
• Other Study ID Numbers: 20151805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The resource sharing plan involves sharing 1) sharing of trial materials and tools, and 2) making bacterial isolates available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No