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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG006244 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study will examine the effect of the EHR-based intervention to improve quality of palliative care for patients 55 years or older with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are:
OVERVIEW: This is a large pragmatic trial of the Jumpstart intervention designed to promote goals-of-care discussions for older, seriously ill, hospitalized patients. The trial recruits consecutively eligible patients from three UW Medicine hospitals. The Jumpstart Guide is a communication-priming intervention that addresses hospitalized patients' goals of care. It includes information, drawn from the electronic health record (EHR), identifying the dates and locations of prior advance care planning documents (e.g. living wills, healthcare directives, durable power of attorney for healthcare, and Physician Orders for Life Sustaining Treatments (POLST)) and patients' code status. This information is provided by email to patients' clinicians. The Jumpstart Guide includes tips to improve this communication. The trial will assess the effectiveness of the EHR-based clinician Jumpstart as compared with usual care.
This current study is "Trial 1" of the R01 Award funding this trial. Trial 2 was initiated following the completion of recruitment for Trial 1.
SPECIFIC AIM 1 (for Trial 1): Evaluate the efficacy of the EHR-based clinician Jumpstart compared to usual care for improving quality of care.
TRIAL 1 has three components.
Component 1- Subject Identification/Recruitment/Randomization: The investigators will use automated methods with EHR data, including natural language processing/machine learning (NLP/ML) approaches, to identify hospitalized patients with serious illness during the first 2-3 days of this specific admission. Screening reports will be produced daily and include all likely eligible patients. Study staff will use these daily screening reports to review individual records of eligible patients for inclusion and exclusion criteria (i.e. verify eligibility). Patients will not be approached for consent. Eligible patients will be assigned to intervention or comparator in a 1:1 ratio. Patients are randomized using variable size blocks and stratified for hospital and ADRD vs. no ADRD.
Component 2- EHR-based Clinician Jumpstart Guide: The Jumpstart guide is developed by applying NLP/ML algorithms to both inpatient and outpatient EHR notes (e.g., progress notes, specialty consult notes, alerts and care plans) preceding the current hospitalization. It summarizes the presence/absence of POLST, advance directives and DPOA (durable power of attorney) documentation and the patients' code status. It also provides general recommendations to initiating goals of care discussions. Jumpstart guides are prepared for the intervention group only.
Component 3- Delivery of the intervention: For the intervention group, the investigators deliver the Jumpstart guide to the primary hospital team (attending and resident physicians and advanced practice providers) via secure email. The Jumpstart guides are delivered within 1 business day of patient randomization. Study staff monitor the care team of the patient, and if there are any changes, ensure that any new providers receive the Jumpstart guide as well.
Comparator: The hospital teams for patients in the control group do not receive Jumpstart guides.
Outcome Assessment. Outcomes are obtained from the EHR and use, in part, NLP/ML methods. The primary outcome is EHR documentation of goals-of-care discussions in the 30 days following randomization. Secondary outcomes are measures of intensity of care, including utilization metrics (i.e., ICU admissions, ICU and hospital lengths of stay, 30-day hospital readmissions), costs of care during hospital admission, and estimated costs of implementing the intervention.
SPECIFIC AIM 2 (Trial 1): Evaluate implementation of the Jumpstart Guide and identify barriers and facilitators to future implementation.
Qualitative evaluation:
Clinician recruitment: Study staff will recruit clinicians who were involved with the study to participate in a short interview after the clinician's study involvement with the enrolled patient has ended. Clinician participants will be selected using purposive sampling to ensure a diverse group (e.g., age, race/ethnicity, gender, specialty, year of training).
Interview: Using an interview guide developed specifically for this project, interviewers will assess respondents' experience with the intervention and gather suggestions for ways to improve the intervention's content, delivery and implementation, including implementation outcomes (e.g., acceptability, fidelity, penetration, maintenance) that will guide future dissemination of the intervention.
Assessment: Interviews are audio recorded, transcribed, and analyzed using thematic analytic methods.
Quantitative evaluation:
Quantitative evaluation for Specific Aim 2 will be guided by the RE-AIM framework. We will evaluate the intervention's: 1) Reach (% of all identified eligible clinicians, patients and families that participated in the study); 2) Adoption (% of eligible services that participated); and 3) Implementation (the proportion of HTML Jumpstart Guides that were opened by a clinician, proportion of patients for whom an HTML JS guide was sent and for whom a JS was opened by a clinician).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EHR-based Clinician Jumpstart | Experimental | The EHR-based Jumpstart Guide will be developed by extracting data from the EHR using automated methods with both inpatient and outpatient notes (e.g., progress notes, specialty consult notes, alerts and care plans) preceding the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation and patients' code status. |
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| Usual Care | No Intervention | The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EHR-based Clinician Jumpstart | Behavioral | The Jumpstart Guide is a communication-priming intervention for clinicians that addresses hospitalized patients' goals of care. The intervention's goal is to prompt clinicians to provide standard of care which includes a discussion with patients or their legal surrogate decision-maker about their goals of care. The one-page Jumpstart Guide provides information to the clinician about prior advance care planning documentation and code status derived from the EHR. The Jumpstart Guides includes tips to improve goals-of-care communication. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With EHR Documentation of Goals of Care Discussions | The primary outcome is the proportion of patients who have a goals-of-care (GOC) discussion that has been documented in the EHR in the period between randomization and 30 days following randomization The proportion is the number of patients with GOC documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our NLP/ML methods. | Assessed for the period between randomization and 30 days following randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of Care/ICU Use: ICU Admissions | Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR. | Assessed for the period between randomization and 30 days following randomization |
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Eligibility criteria apply to two subject groups: 1) seriously ill adult patients; 2) hospital clinicians.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruth Engelberg, PHD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harborview Medical Center | Seattle | Washington | 98104 | United States | ||
| UW Medical Center - Northwest |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35963531 | Background | Curtis JR, Lee RY, Brumback LC, Kross EK, Downey L, Torrence J, Heywood J, LeDuc N, Mallon Andrews K, Im J, Weiner BJ, Khandelwal N, Abedini NC, Engelberg RA. Improving communication about goals of care for hospitalized patients with serious illness: Study protocol for two complementary randomized trials. Contemp Clin Trials. 2022 Sep;120:106879. doi: 10.1016/j.cct.2022.106879. Epub 2022 Aug 10. | |
| 37210665 | Result | Curtis JR, Lee RY, Brumback LC, Kross EK, Downey L, Torrence J, LeDuc N, Mallon Andrews K, Im J, Heywood J, Brown CE, Sibley J, Lober WB, Cohen T, Weiner BJ, Khandelwal N, Abedini NC, Engelberg RA. Intervention to Promote Communication About Goals of Care for Hospitalized Patients With Serious Illness: A Randomized Clinical Trial. JAMA. 2023 Jun 20;329(23):2028-2037. doi: 10.1001/jama.2023.8812. |
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4567 potentially eligible patients identified; 4395 patients screened (1883 ineligible, 2512 eligible); 2512 enrolled.
PATIENTS recruited from 4/23/20 to 3/26/21. A waiver of informed consent and HIPAA authorization obtained for screening and enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | EHR-based Clinician Jumpstart | The EHR-based Jumpstart Guide will be developed by extracting data from the EHR to identify documents uploaded prior to the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation and patients' code status. EHR-based Clinician Jumpstart: The Jumpstart Guide is a communication-priming intervention for clinicians that addresses hospitalized patients' goals of care. The intervention's goal is to prompt clinicians to provide standard of care which includes a discussion with patients or their legal surrogate decision-maker about their goals of care. The one-page Jumpstart Guide provides information to the clinician about prior advance care planning documentation and code status derived from the EHR. The Jumpstart Guides includes tips to improve goals-of-care communication. |
| 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 25, 2022 | Jul 5, 2022 |
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| Intensity of Care/ICU Use: ICU Length of Stay (Number of Days Alive and Out of the ICU) |
Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days alive and out of the ICU within 30 days from randomization will be collected from the EHR. |
| Assessed for the period between randomization and 30 days following randomization |
| Intensity of Care/Hospital Use: Hospital Length of Stay (Number of Days Alive and Out of the Hospital) | Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days alive and out of the hospital within 30 days from randomization will be collected from the EHR. | Assessed for the period between randomization and 30 days following randomization |
| Intensity of Care: Hospital Readmissions 30 Days | Secondary outcomes include measures of intensity of care, including utilization metrics: Proportion of patients readmitted to the hospital following index hospitalization. | Assessed for the period between randomization and 30 days following randomization |
| Intensity of Care: ICU Admissions 30 Days | Secondary outcomes include measures of intensity of care, including utilization metrics: Proportion of patients who received ICU care. | Assessed for the period between randomization and 30 days following randomization |
| Total Hospitalization Costs, Randomization to 30 Days After Randomization | Secondary outcomes include measures of intensity of care, including costs of inpatient care, collected from UW Medicine Finance Office and adjusted for inflation. | Assessed for the period between randomization and 30 days later |
| All-cause Mortality at 30 Days After Randomization (Safety Outcome) | From Washington State death certificates | 30 days after randomization |
| Total Hospitalization Costs, Randomization to Index Hospitalization Discharge | Secondary outcomes include measures of intensity of care, including costs of inpatient care, collected from UW Medicine Finance Office and adjusted for inflation. Assessed for the period between randomization and discharge for the index hospital stay. | Index hospital stay |
| Seattle |
| Washington |
| 98133 |
| United States |
| UW Medical Center - Montlake (UWMC) | Seattle | Washington | 98195 | United States |
| 41680079 | Derived | Lee RY, Li KS, Sibley J, Cohen T, Lober WB, O'Brien J, LeDuc N, Mallon Andrews K, Ungar A, Walsh J, Nielsen EL, Dotolo DG, Kross EK. A modular pipeline for natural language processing-screened human abstraction of a pragmatic trial outcome from electronic health records. Clin Trials. 2026 Apr;23(2):145-154. doi: 10.1177/17407745251405386. Epub 2026 Feb 12. |
| FG001 | Usual Care | The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | EHR-based Clinician Jumpstart | The EHR-based Jumpstart Guide will be developed by extracting data from the EHR to identify documents uploaded prior to the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation and patients' code status. EHR-based Clinician Jumpstart: The Jumpstart Guide is a communication-priming intervention for clinicians that addresses hospitalized patients' goals of care. The intervention's goal is to prompt clinicians to provide standard of care which includes a discussion with patients or their legal surrogate decision-maker about their goals of care. The one-page Jumpstart Guide provides information to the clinician about prior advance care planning documentation and code status derived from the EHR. The Jumpstart Guides includes tips to improve goals-of-care communication. |
| BG001 | Usual Care | The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care. |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | Proportion of Patients With EHR Documentation of Goals of Care Discussions | The primary outcome is the proportion of patients who have a goals-of-care (GOC) discussion that has been documented in the EHR in the period between randomization and 30 days following randomization The proportion is the number of patients with GOC documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our NLP/ML methods. | Posted | Count of Participants | Participants | Assessed for the period between randomization and 30 days following randomization |
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| Secondary | Intensity of Care/ICU Use: ICU Admissions | Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR. | Not Posted | Assessed for the period between randomization and 30 days following randomization | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Intensity of Care/ICU Use: ICU Length of Stay (Number of Days Alive and Out of the ICU) | Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days alive and out of the ICU within 30 days from randomization will be collected from the EHR. | Posted | Mean | Standard Deviation | days | Assessed for the period between randomization and 30 days following randomization |
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| Secondary | Intensity of Care/Hospital Use: Hospital Length of Stay (Number of Days Alive and Out of the Hospital) | Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days alive and out of the hospital within 30 days from randomization will be collected from the EHR. | Posted | Mean | Standard Deviation | days | Assessed for the period between randomization and 30 days following randomization |
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| Secondary | Intensity of Care: Hospital Readmissions 30 Days | Secondary outcomes include measures of intensity of care, including utilization metrics: Proportion of patients readmitted to the hospital following index hospitalization. | Posted | Count of Participants | Participants | Assessed for the period between randomization and 30 days following randomization |
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| Secondary | Intensity of Care: ICU Admissions 30 Days | Secondary outcomes include measures of intensity of care, including utilization metrics: Proportion of patients who received ICU care. | Posted | Count of Participants | Participants | Assessed for the period between randomization and 30 days following randomization |
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| Secondary | Total Hospitalization Costs, Randomization to 30 Days After Randomization | Secondary outcomes include measures of intensity of care, including costs of inpatient care, collected from UW Medicine Finance Office and adjusted for inflation. | (Data unavailable from Finance Office for two patients.) | Posted | Mean | Standard Deviation | US dollars | Assessed for the period between randomization and 30 days later |
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| Secondary | All-cause Mortality at 30 Days After Randomization (Safety Outcome) | From Washington State death certificates | Posted | Count of Participants | Participants | 30 days after randomization |
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| Secondary | Total Hospitalization Costs, Randomization to Index Hospitalization Discharge | Secondary outcomes include measures of intensity of care, including costs of inpatient care, collected from UW Medicine Finance Office and adjusted for inflation. Assessed for the period between randomization and discharge for the index hospital stay. | (Data unavailable from Finance Office for two patients.) | Posted | Mean | Standard Deviation | US dollars | Index hospital stay |
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Randomization through one year following randomization.
No study-related Serious Adverse Events are expected. The Jumpstart intervention is a communication intervention and is unlikely to result in fatal or life-threatening outcomes.
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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 | EHR-based Clinician Jumpstart | The EHR-based Jumpstart Guide will be developed by extracting data from the EHR using automated methods with both inpatient and outpatient notes (e.g., progress notes, specialty consult notes, alerts and care plans) preceding the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation and patients' code status. EHR-based Clinician Jumpstart: The Jumpstart Guide is a communication-priming intervention for clinicians that addresses hospitalized patients' goals of care. The intervention's goal is to prompt clinicians to provide standard of care which includes a discussion with patients or their legal surrogate decision-maker about their goals of care. The one-page Jumpstart Guide provides information to the clinician about prior advance care planning documentation and code status derived from the EHR. The Jumpstart Guides includes tips to improve goals-of-care communication. | 70 | 1,255 | 0 | 1,255 | 0 | 1,255 |
| EG001 | Usual Care | The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care. | 64 | 1,257 | 0 | 1,257 | 0 | 1,257 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janaki Torrence, Research Coordinator | University of Washington | 206-402-7357 | jtorrenc@uw.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2022 | Jul 5, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D002908 | Chronic Disease |
| D009362 | Neoplasm Metastasis |
| D008175 | Lung Neoplasms |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006333 | Heart Failure |
| D008103 | Liver Cirrhosis |
| D007676 | Kidney Failure, Chronic |
| D017563 | Lung Diseases, Interstitial |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014652 | Vascular Diseases |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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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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