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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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This randomized controlled trial will compare strategies to reduce the risk of methicillin-resistant Staphylococcus aureus (MRSA) infection and re-hospitalization in MRSA carriers. This trial will provide critical answers about the role of decolonization versus standard-of-care education in preventing MRSA infections in the large group of high risk MRSA-positive patients being discharged from hospitals. Findings could potentially impact best practice for the 1.8 million MRSA carriers who are discharged from US hospitals each year.
This randomized controlled trial will compare strategies to reduce the risk of methicillin-resistant Staphylococcus aureus (MRSA) infection and re-hospitalization in MRSA carriers. This trial will provide critical answers about the role of decolonization versus standard-of-care education in preventing MRSA infections in the large group of high risk MRSA+ patients being discharged from hospitals. Findings could potentially impact best practice for the 1.8 million MRSA carriers who are discharged from US hospitals each year.
Specific Aims:
Methicillin-resistant Staphylococcus aureus (MRSA) is arguably the most important single pathogen in healthcare-associated infection when accounting for virulence, prevalence, diversity of disease spectrum, and propensity for widespread transmission. MRSA infection causes or complicates 300,000 hospitalizations each year [Klein, Smith, Laxminarayan], a number which has doubled in the past five years. An additional 1.5 million hospitalized patients either acquire or already harbor the pathogen without current infection. Altogether, these 1.8 million MRSA inpatient carriers experience a high amount of MRSA invasive disease in the year following discharge. Due to increased delivery of complex medical care at home or other post-hospital settings, more and more patients experience serious healthcare-associated morbidity after hospital discharge.[Huang, Platt; Huang, Hinrichsen, Stulgis et al.] In fact, over 80% of patients admitted for MRSA infection have had prior healthcare exposures and are at high risk for repeated MRSA infection.[Huang, Platt; Huang, Hinrichsen, Stulgis et al.; Klevens, Morrison, Nadle, et al.]
Project CLEAR compares two strategies to reduce infection and re-hospitalization due to MRSA among patients being discharged from hospitals. Our trial will compare a long-term regimen aimed at eradicating MRSA body reservoirs with patient education on general hygiene and self care, which is the current standard of care. Our specific aims are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRSA Decolonization | Active Comparator | Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month. |
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| Education Arm | Active Comparator | Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard-of-Care Education | Behavioral | Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to MRSA Infection | Time in days to MRSA inpatient or outpatient infection (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to infection; the results we are reporting are number of participants who had an infection event at one year post discharge) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to All-cause Infection (Steering Committee Modified Oct 2011) | Time in days to all-cause infection (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to infection; the results we are reporting are number of participants who had an infection event at one year) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of MRSA Infections | Event count of outpatient and inpatient MRSA infections occurring after enrollment | 1 year |
| Rehospitalization Due to MRSA Infection | Number of participants experiencing rehospitalization due to MRSA infection (first only) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan S Huang, MD, MPH | University of California, Irivne - School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covington Care Center | Aliso Viejo | California | 92656 | United States | ||
| West Anaheim Extended Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18258033 | Background | Klein E, Smith DL, Laxminarayan R. Hospitalizations and deaths caused by methicillin-resistant Staphylococcus aureus, United States, 1999-2005. Emerg Infect Dis. 2007 Dec;13(12):1840-6. doi: 10.3201/eid1312.070629. | |
| 12539068 | Background | Huang SS, Platt R. Risk of methicillin-resistant Staphylococcus aureus infection after previous infection or colonization. Clin Infect Dis. 2003 Feb 1;36(3):281-5. doi: 10.1086/345955. Epub 2003 Jan 17. |
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Recruitment occurred between January 10, 2011 and January 2, 2014, during inpatient admissions in 17 hospitals and 7 nursing homes in Southern California.
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| ID | Title | Description |
|---|---|---|
| FG000 | MRSA Decolonization | Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month. MRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month. |
| 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 | Yes | No | No | Study Protocol | Apr 7, 2011 | Aug 12, 2019 |
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| MRSA Decolonization | Drug | Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month. |
|
| 1 year |
| Cost and Cost Savings Associated With Post-discharge MRSA Decolonization | Medical and non-medical costs of MRSA infection within the 1 year follow up period | 1 year |
| Number of All-cause Infections | Event count of all-cause infections occurring after enrollment | 1 year |
| Anaheim |
| California |
| 92804 |
| United States |
| Downey Regional Medical Center | Downey | California | 90241 | United States |
| Fountain Valley Regional Hospital & Medical Center | Fountain Valley | California | 92708 | United States |
| Orange Coast Memorial Medical Center | Fountain Valley | California | 92708 | United States |
| St. Jude Medical Center | Fullerton | California | 92835 | United States |
| Chapman Care Center | Garden Grove | California | 92840 | United States |
| Pacific Haven HealthCare Center | Garden Grove | California | 92843 | United States |
| Regents Point at Windcrest | Irvine | California | 92612 | United States |
| Saddleback Memorial Medical Center - Laguna Hills | Laguna Hills | California | 92653 | United States |
| Long Beach Memorial Medical Center | Long Beach | California | 90806 | United States |
| St. Mary Medical Center | Long Beach | California | 90813 | United States |
| Mission Hospital | Mission Viejo | California | 92691 | United States |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92658 | United States |
| Villa Elena Health Care Center | Norwalk | California | 90650 | United States |
| UC Irvine Medical Center | Orange | California | 92868 | United States |
| Saddleback Memorial Medical Center - San Clemente | San Clemente | California | 92673 | United States |
| Little Company of Mary - San Pedro | San Pedro | California | 90732 | United States |
| Country Villa Plaza | Santa Ana | California | 92707 | United States |
| Royale Healthcare | Santa Ana | California | 92707 | United States |
| Torrance Memorial Medical Center | Torrance | California | 90505 | United States |
| Providence Little Company of Mary Medical Center | Torrance | California | 90732 | United States |
| Harbor-UCLA Medical Center | Torrence | California | 90502 | United States |
| Ventura County Medical Center | Ventura | California | 93003 | United States |
| Background | Huang SS, Hinrichsen VH, Stulgis L, Miroshnik I, Datta R, Watson K, Platt R. Methicillin-resistant Staphylococcus aureus Infection in the Year Following Detection of Carriage (oral presentation). Society of Healthcare Epidemiology of America Annual Meeting (Chicago, IL), March 18-21, 2006. |
| 17940231 | Background | Klevens RM, Morrison MA, Nadle J, Petit S, Gershman K, Ray S, Harrison LH, Lynfield R, Dumyati G, Townes JM, Craig AS, Zell ER, Fosheim GE, McDougal LK, Carey RB, Fridkin SK; Active Bacterial Core surveillance (ABCs) MRSA Investigators. Invasive methicillin-resistant Staphylococcus aureus infections in the United States. JAMA. 2007 Oct 17;298(15):1763-71. doi: 10.1001/jama.298.15.1763. |
| 30763195 | Derived | Huang SS, Singh R, McKinnell JA, Park S, Gombosev A, Eells SJ, Gillen DL, Kim D, Rashid S, Macias-Gil R, Bolaris MA, Tjoa T, Cao C, Hong SS, Lequieu J, Cui E, Chang J, He J, Evans K, Peterson E, Simpson G, Robinson P, Choi C, Bailey CC Jr, Leo JD, Amin A, Goldmann D, Jernigan JA, Platt R, Septimus E, Weinstein RA, Hayden MK, Miller LG; Project CLEAR Trial. Decolonization to Reduce Postdischarge Infection Risk among MRSA Carriers. N Engl J Med. 2019 Feb 14;380(7):638-650. doi: 10.1056/NEJMoa1716771. |
| FG001 | Education Arm | Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided. Standard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MRSA Decolonization | Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month. MRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month. |
| BG001 | Education Arm | Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided. Standard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Time to MRSA Infection | Time in days to MRSA inpatient or outpatient infection (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to infection; the results we are reporting are number of participants who had an infection event at one year post discharge) | Outcomes were analyzed according to the as-treated adherence strata (fully adherent, partially adherent, and nonadherent participant-time) | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Time to All-cause Infection (Steering Committee Modified Oct 2011) | Time in days to all-cause infection (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to infection; the results we are reporting are number of participants who had an infection event at one year) | Posted | Count of Participants | Participants | 1 year |
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| Other Pre-specified | Number of MRSA Infections | Event count of outpatient and inpatient MRSA infections occurring after enrollment | Posted | Apr 2025 | Number | MRSA Infection Events | No | 1 year |
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| Other Pre-specified | Rehospitalization Due to MRSA Infection | Number of participants experiencing rehospitalization due to MRSA infection (first only) | Posted | Apr 2025 | Count of Participants | Participants | 1 year |
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| Other Pre-specified | Cost and Cost Savings Associated With Post-discharge MRSA Decolonization | Medical and non-medical costs of MRSA infection within the 1 year follow up period | Not Posted | Apr 2027 | 1 year | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of All-cause Infections | Event count of all-cause infections occurring after enrollment | Posted | Apr 2025 | Number | All-cause infection events | 1 year |
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Adverse events were actively assessed from January 2011-January 2015. Participants were recruited from January 2011-January 2014 and were followed for 1 year. Evaluation of the full text medical record reviews for adverse events occurred for several years after recruitment ended in 2014.
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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 | MRSA Decolonization | Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month. MRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month. | 0 | 1,058 | 0 | 1,058 | 48 | 1,058 |
| EG001 | Education Arm | Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided. Standard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. | 0 | 1,063 | 0 | 1,063 | 0 | 1,063 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal Mupirocin (2%) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Congestion |
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| Nasal Mupirocin (2%) | General disorders | Non-systematic Assessment | Headache |
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| Nasal Mupirocin (2%) | General disorders | Non-systematic Assessment | Dizziness |
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| Nasal Mupirocin (2%) | General disorders | Non-systematic Assessment | Numb throat, tast change |
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| Nasal Mupirocin (2%) | General disorders | Non-systematic Assessment | Runny, itchy nose |
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| Nasal Mupirocin (2%) | General disorders | Non-systematic Assessment | Runny nose |
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| Nasal Mupirocin (2%) | General disorders | Non-systematic Assessment | Loss of smell and taste |
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| Chlorhexidine Mouthwash (0.12%) | General disorders | Non-systematic Assessment | Tongue discoloration |
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| Chlorhexidine Mouthwash (0.12%) | General disorders | Non-systematic Assessment | Tingling tongue |
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| Chlorhexidine Mouthwash (0.12%) | General disorders | Non-systematic Assessment | Tingling of mouth |
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| Chlorhexidine Mouthwash (0.12%) | General disorders | Non-systematic Assessment | Teeth staining |
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| Chlorhexidine Mouthwash (0.12%) | General disorders | Non-systematic Assessment | Dry mouth |
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| Chlorhexidine Mouthwash (0.12%) | General disorders | Non-systematic Assessment | Oral irritation |
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| Chlorhexidine Bodywash (4%) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Itchy, dry hands |
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| Chlorhexidine Bodywash (4%) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Itchy body |
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| Chlorhexidine Bodywash (4%) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Itchy face and neck |
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| Chlorhexidine Bodywash (4%) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Itchy, dry scalp |
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| Chlorhexidine Bodywash (4%) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Dry skin |
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| Chlorhexidine Bodywash (4%) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Dry, flaky hands and feet |
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| Chlorhexidine Bodywash (4%) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Burning sensation |
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| Chlorhexidine Bodywash (4%) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Rash: trunk |
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| Chlorhexidine Bodywash (4%) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Rash: body |
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| Chlorhexidine Bodywash (4%) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Rash: face and neck |
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| Chlorhexidine Bodywash (4%) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Rash: chest |
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| Chlorhexidine Bodywash (4%) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Rash: legs |
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| Chlorhexidine Bodywash (4%) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Rash: scrotal |
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| Chlorhexidine Bodywash (4%) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Rash: neck, limbs |
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| Chlorhexidine Bodywash (4%) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Rash and dryness |
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| Chlorhexidine Bodywash (4%) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Rash: leg |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Huang, Principal Investigator & Medical Director of Epidemiology and Infection Prevention | University of California, Irvine | 949-824-5073 | sshuang@uci.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 18, 2012 | Aug 12, 2019 | SAP_001.pdf |
| Male |
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| Black |
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| Asian |
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| American Indian |
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| Other |
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| Unknown/Not Reported |
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