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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21NR018952 | U.S. NIH Grant/Contract | View source | |
| 310245 | Other Identifier | Rush University | |
| 310244 | Other Identifier | Rush University | |
| 310243 | Other Identifier | Rush Univesrity |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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Poor adherence to pain management and high pain intensity associated with serious, advanced illness is a major public health concern. This randomized clinical trial will test the efficacy of a newly enhanced digital pain and pain management application (e-PainSupport) for use in a home hospice setting. The e-PainSupport application delivers an education module about pain management to patients and caregivers, expedites pain reporting to nurses, and facilitates adherence to pain management. The overall goal of the e-PainSupport application is to improve pain management and reduce patient pain intensity in the home hospice setting.
High pain intensity is a common symptom experienced by patients with serious advanced illness. However, pain management for patients in home hospice is less than optimal. Impediments to improving pain intensity are poor adherence to pain management regimen due in part to caregiver lack of knowledge (a barrier to reporting pain and using analgesics) and lack of self-efficacy (confidence) in administering analgesics. Digital applications may facilitate pain management by: (1) delivering education to increase knowledge and self-efficacy, (2) expediting pain reporting to nurses, and (3) improving adherence to pain management. e-PainSupport is a self-administered, digital pain management application developed in collaboration with hospice nurses and caregivers. It is directly linked to a patient's medical record and enhanced by an evidence-based educational module. It has three elements: (a) Educational Module, (b) Patient Pain Record, and (c) Pain Summary for Nurses. The purpose of this study is to test the effects of e-PainSupport on home hospice patient pain intensity when used by patients, caregivers and nurses. Participants (132 triads of patient, caregiver, and the hospice nurse assigned to the patient will be recruited from one large Midwest hospice agency. Patient and caregiver outcomes will be assessed at baseline and 2 weeks post baseline. Data will be analyzed with multi-level modeling. Post-intervention semi-structured interviews will be conducted with nurses who provided care to patients in the e-PainSupport condition. Qualitative content analysis will be used to identify themes related to perceived practice changes after using e-PainSupport. e-PainSupport has potential as a useful tool to advance home hospice care by enhancing the quality of caregiver pain management, facilitating nurse-patient communication, and improving management of patient pain intensity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| e-PainSupport Condition | Experimental | e-PainSupport is a self-administered, digital pain application. Over the course of the two weeks, caregivers and patients will record the severity of patient's pain and how much pain medicine they use to control patient's pain in the e-PainSupport application. |
|
| Standard Care Condition | No Intervention | Patients and caregivers will be given a paper copy of the same list of resources for pain management included in the Education Module of the e-PainSupport condition at baseline. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e-PainSupport | Behavioral | Patients and caregivers assigned to the e-PainSupport condition will download the app on their own device, or they will be given a project tablet with wireless capability if they do not have their own device. All receive specific training for the intervention. They will also receive a hardcopy of the e-PainSupport manual and a trouble-shooting guide. Contact information will be provided in the app and on paper for technical problems. Caregivers complete Education Module, and patients may complete it. Caregiver or patient will fill out Pain Report daily. Pain Summary for Nurses is an automatically generated graphic summary of patients' Pain Reports over time. Nurses have access to this information during the time the patients and caregivers use e-PainSupport. |
| Measure | Description | Time Frame |
|---|---|---|
| Minimally Important Clinical Change in Worst Pain Intensity | At least 20 percent change on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0: 3 items: Worst pain and average pain in past 7 days scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain. Higher scores indicates higher pain intensity. | Baseline to 2-weeks post baseline |
| Minimally Important Clinical Change in Average Pain Intensity | At Least 20 Percent Change on the PROMIS Average Pain Scale. Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0: Average pain in past 7 days, and current pain, scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain, summed for a range of 3 to 15. Higher scores indicates higher pain intensity. | Baseline to 2-weeks post baseline |
| Minimally Important Clinical Change in Current Pain Intensity | At least 20 percent change on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0: 3 items: current pain, scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain. Higher scores indicates higher pain intensity. | Baseline to 2-weeks post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Continuous Score of the Pain Intensity Scale | Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0. 3items: worst pain and average pain in past 7 days, and current pain, scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain, summed for a range of 3 to 15. Higher scores indicates higher pain intensity. | Baseline to 2-weeks post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Self-efficacy: Difference in Self-efficacy Scores From Baseline to 14 Days | Chronic Pain Self-Efficacy Scale and the two weeks post baseline: Self-efficacy for pain management subscale measures confidence in managing pain, 5 items on 10-point Likert scale anchored on the ends by 10=very uncertain and 100=very certain. The score ranges from 50 to 500. Higher scores indicate higher perceived self efficacy. |
Inclusion criteria (patient)
Inclusion criteria (caregiver)
Inclusion criteria (nurses participating in the RTC)
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| Name | Affiliation | Role |
|---|---|---|
| Masako Mayahara, PhD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23236090 | Background | Kehl KA, Kowalkowski JA. A systematic review of the prevalence of signs of impending death and symptoms in the last 2 weeks of life. Am J Hosp Palliat Care. 2013 Sep;30(6):601-16. doi: 10.1177/1049909112468222. Epub 2012 Dec 12. | |
| 25643305 | Background | Singer AE, Meeker D, Teno JM, Lynn J, Lunney JR, Lorenz KA. Symptom trends in the last year of life from 1998 to 2010: a cohort study. Ann Intern Med. 2015 Feb 3;162(3):175-83. doi: 10.7326/M13-1609. |
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| ID | Title | Description |
|---|---|---|
| FG000 | e-PainSupport Condition | e-PainSupport is a self-administered, digital pain application. Over the course of the two weeks, caregivers and patients will record the severity of patient's pain and how much pain medicine they use to control patient's pain in the e-PainSupport application. e-PainSupport: Patients and caregivers assigned to the e-PainSupport condition will download the app on their own device, or they will be given a project tablet with wireless capability if they do not have their own device. All receive specific training for the intervention. They will also receive a hardcopy of the e-PainSupport manual and a trouble-shooting guide. Contact information will be provided in the app and on paper for technical problems. Caregivers complete Education Module, and patients may complete it. Caregiver or patient will fill out Pain Report daily. Pain Summary for Nurses is an automatically generated graphic summary of patients' Pain Reports over time. Nurses have access to this information during the time the patients and caregivers use e-PainSupport. |
| FG001 | Standard Care Condition | Patients and caregivers will be given a paper copy of the same list of resources for pain management included in the Education Module of the e-PainSupport condition at baseline. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | e-PainSupport Condition | e-PainSupport is a self-administered, digital pain application. Over the course of the two weeks, caregivers and patients will record the severity of patient's pain and how much pain medicine they use to control patient's pain in the e-PainSupport application. e-PainSupport: Patients and caregivers assigned to the e-PainSupport condition will download the app on their own device, or they will be given a project tablet with wireless capability if they do not have their own device. All receive specific training for the intervention. They will also receive a hardcopy of the e-PainSupport manual and a trouble-shooting guide. Contact information will be provided in the app and on paper for technical problems. Caregivers complete Education Module, and patients may complete it. Caregiver or patient will fill out Pain Report daily. Pain Summary for Nurses is an automatically generated graphic summary of patients' Pain Reports over time. Nurses have access to this information during the time the patients and caregivers use e-PainSupport. |
| 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 | Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). |
| 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 | Minimally Important Clinical Change in Worst Pain Intensity | At least 20 percent change on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0: 3 items: Worst pain and average pain in past 7 days scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain. Higher scores indicates higher pain intensity. | A total of 44 patients and 44 caregivers participated in the study. The outcome was measured only in patients (n=44). Among these patients, 23 were in the intervention condition (e-PainSupport) and 21 were in the standard care condition. Of the 23 patients in the intervention condition, only 20 completed the measure. In the standard care condition, 16 out of the 21 patients completed the measure. | Posted | Count of Participants | Participants | Baseline to 2-weeks post baseline |
|
From the beginning to the end of the study (2 weeks).
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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 | e-PainSupport Condition- Patient | Please note that adverse event reporting applies only to study participants and is reported using the e Pain Support application to record and track their pain levels. Caregivers are not considered study participants for adverse event assessment; their role is limited to assisting patients in completing the e Pain Support application. Accordingly, only patients are at risk of potential adverse events if any occur. Description: e-PainSupport is a self-administered, digital pain application. Over the course of the two weeks, caregivers and patients will record the severity of patient's pain and how much pain medicine they use to control patient's pain in the e-PainSupport application. e-PainSupport: Patients and caregivers assigned to the e-PainSupport condition will download the app on their own device, or they will be given a project tablet with wireless capability if they do not have their own device. All receive specific training for the intervention. They will also receive a hardcopy of the e-PainSupport manual and a trouble-shooting guide. Contact information will be provided in the app and on paper for technical problems. Caregivers complete Education Module, and patients may complete it. Caregiver or patient will fill out Pain Report daily. Pain Summary for Nurses is an automatically generated graphic summary of patients' Pain Reports over time. Nurses have access to this information during the time the patients and caregivers use e-PainSupport. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Masako Mayahara | Washington University in St. Louis | 847-738-0951 | masakom@wustl.edu |
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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 | Mar 21, 2023 | Oct 5, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 21, 2023 | Oct 5, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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Data Collectors will be blinded to the intervention. Study participants will be asked to not disclose their treatment condition.
|
| Baseline to 2-weeks post baseline |
| Adherence to Pain Management: Difference in Change Scores From Baseline to 14 Days | Morisky Medication Adherence Scale-4 item version: Measures medication adherence, 4 items on a five-point Likert scale. Patients answer yes or no to questions (e.g., Do you sometimes forget to take your pain medication?).Each "yes" answer is scored as 1.The score ranges from 0 to 4. Lower score indicates better adherence. | Baseline to 2-weeks post baseline |
| Family Caregiver Knowledge: Difference in Change Scores From Baseline to 14 Days | Barriers Questionnaire II measures 8 knowledge barriers about reporting pain and using analgesics, with four subscales (physiological effects, 12 items; fatalism, 3 items; communication, 6 items; and harmful effects, 6 items (total 27 items) on a 6-point scale (0 = don't agree, 5 = agree very much), items averaged (range 0 to 5). The score ranges from 0-135. Higher scores indicate stronger barriers. | Baseline to 2-weeks post baseline |
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| 17363323 | Result | Lind L, Karlsson D, Fridlund B. Patients' use of digital pens for pain assessment in advanced palliative home healthcare. Int J Med Inform. 2008 Feb;77(2):129-36. doi: 10.1016/j.ijmedinf.2007.01.013. Epub 2007 Mar 23. |
| 37897444 | Result | Mayahara M, Wilbur J, Fogg L, Paice JA, Miller AM. e-PainSupport: A Digital Pain Management Application for Home Hospice Care. Am J Hosp Palliat Care. 2024 Oct;41(10):1120-1126. doi: 10.1177/10499091231211493. Epub 2023 Oct 28. |
| 40495339 | Derived | Mayahara M, Wilbur J, Fogg L, Houlihan MC, Oliver DP, Benson JJ, Miller AM. The e-PainSupport Digital Application for Assessing Pain and Pain Management in Home Hospice: A Randomized Controlled Trial. West J Nurs Res. 2025 Aug;47(8):708-719. doi: 10.1177/01939459251338392. Epub 2025 Jun 10. |
| BG001 | Standard Care Condition | Patients and caregivers will be given a paper copy of the same list of resources for pain management included in the Education Module of the e-PainSupport condition at baseline. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
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| Age, Continuous | Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). | Mean | Standard Deviation | years |
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| Sex: Female, Male | There were 44 caregivers who responded. There were 44 patients who responded. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs) | Count of Participants | Participants |
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| Race (NIH/OMB) | Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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e-PainSupport is a self-administered, digital pain application. Over the course of the two weeks, caregivers and patients will record the severity of patient's pain and how much pain medicine they use to control patient's pain in the e-PainSupport application.
e-PainSupport: Patients and caregivers assigned to the e-PainSupport condition will download the app on their own device, or they will be given a project tablet with wireless capability if they do not have their own device. All receive specific training for the intervention. They will also receive a hardcopy of the e-PainSupport manual and a trouble-shooting guide. Contact information will be provided in the app and on paper for technical problems. Caregivers complete Education Module, and patients may complete it. Caregiver or patient will fill out Pain Report daily. Pain Summary for Nurses is an automatically generated graphic summary of patients' Pain Reports over time. Nurses have access to this information during the time the patients and caregivers use e-PainSupport.
| OG001 | Standard Care Condition | Patients and caregivers will be given a paper copy of the same list of resources for pain management included in the Education Module of the e-PainSupport condition at baseline. |
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| Primary | Minimally Important Clinical Change in Average Pain Intensity | At Least 20 Percent Change on the PROMIS Average Pain Scale. Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0: Average pain in past 7 days, and current pain, scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain, summed for a range of 3 to 15. Higher scores indicates higher pain intensity. | A total of 88 patients and caregivers participated in the study. This outcome was only measured in patients (n=44). A total of 23 were in the intervention and 21 were in the standard care condition. Of 23, only 16 completed this measure in the e-PainSupport condition and of 21, only 18 completed in the standard care condition. | Posted | Count of Participants | Participants | Baseline to 2-weeks post baseline |
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| Primary | Minimally Important Clinical Change in Current Pain Intensity | At least 20 percent change on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0: 3 items: current pain, scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain. Higher scores indicates higher pain intensity. | A total of 88 patients and caregivers participated in the study. This outcome was only measured in patients (n=44). A total of 23 were in the intervention and 21 were in the standard care condition. Of 23, only 16 completed this measure in the e-PainSupport condition and of 21, only 20 completed in the standard care condition. | Posted | Count of Participants | Participants | Baseline to 2-weeks post baseline |
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| Secondary | Change in the Continuous Score of the Pain Intensity Scale | Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0. 3items: worst pain and average pain in past 7 days, and current pain, scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain, summed for a range of 3 to 15. Higher scores indicates higher pain intensity. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 2-weeks post baseline |
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| Other Pre-specified | Caregiver Self-efficacy: Difference in Self-efficacy Scores From Baseline to 14 Days | Chronic Pain Self-Efficacy Scale and the two weeks post baseline: Self-efficacy for pain management subscale measures confidence in managing pain, 5 items on 10-point Likert scale anchored on the ends by 10=very uncertain and 100=very certain. The score ranges from 50 to 500. Higher scores indicate higher perceived self efficacy. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 2-weeks post baseline |
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| Other Pre-specified | Adherence to Pain Management: Difference in Change Scores From Baseline to 14 Days | Morisky Medication Adherence Scale-4 item version: Measures medication adherence, 4 items on a five-point Likert scale. Patients answer yes or no to questions (e.g., Do you sometimes forget to take your pain medication?).Each "yes" answer is scored as 1.The score ranges from 0 to 4. Lower score indicates better adherence. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 2-weeks post baseline |
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| Other Pre-specified | Family Caregiver Knowledge: Difference in Change Scores From Baseline to 14 Days | Barriers Questionnaire II measures 8 knowledge barriers about reporting pain and using analgesics, with four subscales (physiological effects, 12 items; fatalism, 3 items; communication, 6 items; and harmful effects, 6 items (total 27 items) on a 6-point scale (0 = don't agree, 5 = agree very much), items averaged (range 0 to 5). The score ranges from 0-135. Higher scores indicate stronger barriers. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 2-weeks post baseline |
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| 5 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Standard Care Condition-- Patient | Please note that adverse event reporting applies only to study participants and is reported using the e Pain Support application to record and track their pain levels. Caregivers are not considered study participants for adverse event assessment; their role is limited to assisting patients in completing the e Pain Support application. Accordingly, only patients are at risk of potential adverse events if any occur. Description: Patients and caregivers will be given a paper copy of the same list of resources for pain management included in the Education Module of the e-PainSupport condition at baseline. | 1 | 42 | 0 | 42 | 0 | 42 |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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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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| 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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