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Completed

NCT Number: NCT03118232

Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization

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.

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Key information

Conditions

Hospitalization Infection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Anaheim Crest Nursing Center, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Hospital Transfers Due to Infection

    Time frame: 18 months

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

Secondary outcomes

  1. All Hospital Transfers

    Time frame: 18 months

    Probability that a discharge is to a hospital

Other outcomes

  1. Multidrug-resistant Organism (MDRO) Colonization (Secondary Manuscript)

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

    Probability of colonization with any multidrug-resistant organism (MDRO): (MRSA, VRE, ESBL, CRE)

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

    Time frame: 18 months

    Probability that a transfer to a hospital is due to an infection for long stay and short stay resident subsets

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

    Time frame: 18 months

    Probability that a discharge is to a hospital for long stay and short stay resident subsets

  4. Emergency Department Transfers Due to Infection (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017)

    Time frame: 18 months

    Probability that a resident is sent to the emergency department for an infection, overall for long stay and short stay resident subsets

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

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

Registry information

Acronym: PROTECT

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2017
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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