search
Back to results

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

Primary Purpose

Hospitalization, Infection

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine gluconate (CHG)
Iodophor (10% povidone-iodine)
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hospitalization focused on measuring Nursing Homes, Health Facilities, Infections, Readmissions, Multi-Drug resistance, Antibiotic Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Decolonization

Routine Bathing

Arm Description

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

Routine bathing per facility protocol.

Outcomes

Primary Outcome Measures

Hospital Transfers Due to Infection
Probability that a transfer to a hospital is due to an infection

Secondary Outcome Measures

All Hospital Transfers
Probability that a discharge is to a hospital

Full Information

First Posted
February 21, 2017
Last Updated
June 30, 2023
Sponsor
University of California, Irvine
Collaborators
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, University of Massachusetts, Amherst, Agency for Healthcare Research and Quality (AHRQ)
search

1. Study Identification

Unique Protocol Identification Number
NCT03118232
Brief Title
Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization
Acronym
PROTECT
Official Title
Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, University of Massachusetts, Amherst, Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospitalization, Infection
Keywords
Nursing Homes, Health Facilities, Infections, Readmissions, Multi-Drug resistance, Antibiotic Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Decolonization
Arm Type
Active Comparator
Arm Description
Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.
Arm Title
Routine Bathing
Arm Type
No Intervention
Arm Description
Routine bathing per facility protocol.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate (CHG)
Intervention Description
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
Intervention Name(s)
Iodophor (10% povidone-iodine)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital Transfers Due to Infection
Description
Probability that a transfer to a hospital is due to an infection
Time Frame
18 months
Secondary Outcome Measure Information:
Title
All Hospital Transfers
Description
Probability that a discharge is to a hospital
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
Multidrug-resistant organism (MDRO) colonization (Secondary manuscript, Original protocol)
Description
Probability of colonization with any multidrug-resistant organism (MDRO): (MRSA, VRE, ESBL, CRE)
Time Frame
Once in baseline and once at end-intervention (month 15-18 of intervention period)
Title
Hospital Transfers Due to Infection in Long Stay and Short Stay Subsets (Secondary manuscript, added by Steering Committee decision on 3/22/2017)
Description
Probability that a transfer to a hospital is due to an infection for long stay and short stay resident subsets
Time Frame
18 months
Title
All Hospital Transfers in Long Stay and Short Stay Subsets (Secondary manuscript, added by Steering Committee decision on 3/22/2017)
Description
Probability that a discharge is to a hospital for long stay and short stay resident subsets
Time Frame
18 months
Title
Emergency Department Transfers Due to Infection (Secondary manuscript, added by Steering Committee decision on 3/22/2017)
Description
Probability that a resident is sent to the emergency department for an infection, overall for long stay and short stay resident subsets
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Huang, MD MPH
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Loren Miller, MD MPH
Organizational Affiliation
Harbor UCLA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
James McKinnell, MD
Organizational Affiliation
Harbor UCLA
Official's Role
Study Director
Facility Information:
Facility Name
Buena Vista Care Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92802
Country
United States
Facility Name
Walnut Village Rehabilitation and Care Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92802
Country
United States
Facility Name
Anaheim Crest Nursing Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Sun Mar Nursing Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
West Anaheim Extended Care
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Bel Tooren Villa Convalescent Hospital
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Capistrano Beach Care Center
City
Capistrano Beach
State/Province
California
ZIP/Postal Code
92624
Country
United States
Facility Name
Downey Care Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
Gordon Lane Care Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92831
Country
United States
Facility Name
Windsor Gardens Care Center of Fullerton
City
Fullerton
State/Province
California
ZIP/Postal Code
92832
Country
United States
Facility Name
Terrace View Care Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Pacific Haven Subacute Healthcare Center
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Las Flores Convalescent Hospital
City
Gardena
State/Province
California
ZIP/Postal Code
90249
Country
United States
Facility Name
Park Regency Care Center
City
La Habra
State/Province
California
ZIP/Postal Code
90631
Country
United States
Facility Name
Regency Oaks Post Acute Care Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90804
Country
United States
Facility Name
Windsor Convalescent of North Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
Bixby Knolls Healthcare Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Pacific Villa Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Vista Cove Care Center at Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Intercommunity Care Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90815
Country
United States
Facility Name
Royal Oaks Care Center
City
Lynwood
State/Province
California
ZIP/Postal Code
90262
Country
United States
Facility Name
Norwalk Skilled Nursing and Wellness Center
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Villa Elena Care Center
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Harbor Post-Acute Care Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Heritage Rehabilitation Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Sunnyside Nursing Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Torrance Care Center West
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
Del Amo Gardens Care Center
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The resource sharing plan involves sharing 1) sharing of trial materials and tools, and 2) making bacterial isolates available.

Learn more about this trial

Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization

We'll reach out to this number within 24 hrs