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| Name | Class |
|---|---|
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | OTHER |
| University of Massachusetts, Amherst | OTHER |
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decolonization | Active Comparator | Nursing homes assigned to this arm will perform decolonization using topical antiseptic products. |
|
| Routine Bathing | No Intervention | Routine bathing per facility protocol. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Transfers Due to Infection | Probability that a transfer to a hospital is due to an infection | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| All Hospital Transfers | Probability that a discharge is to a hospital | 18 months |
| 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) |
Inclusion Criteria
Nursing homes will be eligible to participate if they meet the following criteria:
Exclusion Criteria
Nursing homes will not be eligible to participate if they meet the following criteria:
Note: in any participating nursing home, residents with active end-of-life comfort care only measures are excluded
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buena Vista Care Center | Anaheim | California | 92802 | United States | ||
| Walnut Village Rehabilitation and Care Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37815935 | Derived | 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. |
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The resource sharing plan involves sharing 1) sharing of trial materials and tools, and 2) making bacterial isolates available.
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| ID | Title | Description |
|---|---|---|
| FG000 | Decolonization | Nursing homes assigned to this arm will perform decolonization using topical antiseptic products. 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2019 |
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| 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. |
|
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 |
| Anaheim |
| California |
| 92802 |
| United States |
| Anaheim Crest Nursing Center | Anaheim | California | 92804 | United States |
| Sun Mar Nursing Center | Anaheim | California | 92804 | United States |
| West Anaheim Extended Care | Anaheim | California | 92804 | United States |
| Bel Tooren Villa Convalescent Hospital | Bellflower | California | 90706 | United States |
| Capistrano Beach Care Center | Capistrano Beach | California | 92624 | United States |
| Downey Care Center | Downey | California | 90242 | United States |
| Gordon Lane Care Center | Fullerton | California | 92831 | United States |
| Windsor Gardens Care Center of Fullerton | Fullerton | California | 92832 | United States |
| Terrace View Care Center | Fullerton | California | 92835 | United States |
| Pacific Haven Subacute Healthcare Center | Garden Grove | California | 92843 | United States |
| Las Flores Convalescent Hospital | Gardena | California | 90249 | United States |
| Park Regency Care Center | La Habra | California | 90631 | United States |
| Regency Oaks Post Acute Care Center | Long Beach | California | 90804 | United States |
| Windsor Convalescent of North Long Beach | Long Beach | California | 90805 | United States |
| Bixby Knolls Healthcare Center | Long Beach | California | 90807 | United States |
| Pacific Villa Inc. | Long Beach | California | 90807 | United States |
| Vista Cove Care Center at Long Beach | Long Beach | California | 90807 | United States |
| Intercommunity Care Center | Long Beach | California | 90815 | United States |
| Royal Oaks Care Center | Lynwood | California | 90262 | United States |
| Norwalk Skilled Nursing and Wellness Center | Norwalk | California | 90650 | United States |
| Villa Elena Care Center | Norwalk | California | 90650 | United States |
| Harbor Post-Acute Care Center | Torrance | California | 90502 | United States |
| Heritage Rehabilitation Center | Torrance | California | 90502 | United States |
| Sunnyside Nursing Center | Torrance | California | 90502 | United States |
| Torrance Care Center West | Torrance | California | 90503 | United States |
| Del Amo Gardens Care Center | Torrance | California | 90505 | United States |
| FG001 | Routine Bathing | Routine bathing per facility protocol. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Decolonization | Nursing homes assigned to this arm will perform decolonization using topical antiseptic products. 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. 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. |
| BG001 | Routine Bathing | Routine bathing per facility protocol. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hospital Transfers Due to Infection | Probability that a transfer to a hospital is due to an infection | Analysis is of residents accounting for clustering in 28 nursing homes | Posted | Number | Transfers | 18 months |
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| Secondary | All Hospital Transfers | Probability that a discharge is to a hospital | Analysis is of residents accounting for clustering in 28 nursing homes | Posted | Number | Transfers | 18 months |
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| Other Pre-specified | Multidrug-resistant Organism (MDRO) Colonization (Secondary Manuscript) | Probability of colonization with any multidrug-resistant organism (MDRO): (MRSA, VRE, ESBL, CRE) | Posted | Count of Participants | Participants | Once in baseline and once at end-intervention (month 15-18 of intervention period) |
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| Other Pre-specified | 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 | Not Posted | 18 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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 | Not Posted | 18 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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 | Not Posted | 18 months | Participants |
18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Decolonization | Nursing homes assigned to this arm will perform decolonization using topical antiseptic products. 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. 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. | 0 | 7,388 | 0 | 7,388 | 35 | 7,388 |
| EG001 | Routine Bathing | Routine bathing per facility protocol. | 0 | 6,564 | 0 | 6,564 | 0 | 6,564 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rashes | Product Issues | Non-systematic Assessment |
| ||
| Sore throat | Product Issues | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Huang | University of California, Irvine | 714-456-5047 | sshuang@hs.uci.edu |
| Nov 9, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| D007466 | Iodophors |
| D011206 | Povidone-Iodine |
| ID | Term |
|---|---|
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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