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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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The project seeks to study the use of an navigator-based intervention called "PICU Supports." The study will test the impact of PICU Supports during and after PICU discharge on parent outcomes (satisfaction with decision making, decision regret, anxiety, depression, post-traumatic stress, health-related quality of life, and complicated bereavement) and on parent and healthcare team member assessments of communication and team collaboration.
Parents of children admitted to the PICU often face challenging decisions. Research demonstrates deficiencies in communication in the PICU which could impact decision making. This study team has developed a navigator-based intervention call PICU Supports. PICU Supports aims to provide the following types of support to parents of patients in the PICU: emotional; communication (between healthcare team members and parents/families as well as among healthcare team members ); decision making; transitions out of the PICU (i.e. discharge transitions to a non-PICU hospital bed, a long term care facility, or home); and information. Support is accomplished by navigator engagement with parents and healthcare team members and the guided use of navigator supported ancillary tools provided to parents and healthcare team members as needed. During the patient's PICU stay, the navigator activities and use of ancillary tools is directed by the family's needs. Thus PICU Supports uses a predefined framework of activities and tools to provide individualized support directed by the needs of the parent and the patient situation. This research will test PICU Supports in the clinical setting. This will be accomplished by conducting a pilot study of PICU Supports at Ann & Robert H. Lurie Children's Hospital of Chicago (Lurie Children's Hospital), followed by a randomized controlled trial (RCT) comparing the intervention, PICU Supports, to a control, parental receipt of an educational brochure. The RCT will be conducted at Lurie Children's Hospital and at University of Chicago Medicine Comer Children's Hospital (Comer Children's Hospital).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PICU Supports | Experimental | Participants will receive the PICU Supports intervention. |
|
| Educational Brochure | Active Comparator | Participants will receive an educational brochure about the pediatric intensive care unit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICU Supports | Other | The PICU Supports intervention includes navigator activities and ancillary tools. The Navigator activities include: initial visits with the healthcare team members (HTMs) and parents; weekday visits with the parents and feedback to the HTMs as needed; coordination of weekly family meetings between the parents and HTMs; and support during transitions out of the unit. The ancillary tools include: a PICU handbook; a place for parents to keep track of events and their goals; a provider sheet to inform PICU HTMs about important parental issues, concerns or goals; a bedside communication log so parents know which non-PICU HTMs have visited; an end-of-life checklist; a bereavement packet for those whose child dies; and informational resources. |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction With Decision Making (Percentage of "Excellent" Scores in the Decision Making Domain of the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire) | Percentage of "excellent" scores in the decision making domain of the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire; minimum=0, maximum=100, higher score is better outcome | 3-5 weeks following PICU discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Family Decision Making Satisfaction in the Intensive Care Unit (pFS-ICU) | Measures satisfaction of family who have a child admitted to the Pediatric intensive care unit; Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire mean score, range 0-100, higher score is the better outcome | 3-5 weeks following PICU discharge |
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Inclusion Criteria:
Case Patients
Case patients will be included in the study if one of his/her parents agrees to participate in the study and signs a written consent form.
Parents of case patients
Healthcare Team Members for the pre-post assessment of team communication and focus group:
-This group will include as many clinicians in the following groups as possible (identified by the site principal investigator): PICU physicians (attendings and fellows); PICU bedside nurses; PICU Advance Practice Nurses (APNs); hospitalists; subspecialty physicians who consult on PICU patients; subspecialty APNs who consult on PICU patients; PICU respiratory therapist; PICU physical/occupational/speech therapists; and social workers (SWs), chaplains, and case managers who follow PICU patients.
Healthcare team members for the written feedback/assessment of the intervention:
-HTMs caring for the case patient at the time of PICU discharge: (PICU attending; PICU fellow; social worker (if involved); chaplain (if involved); bedside nurse; PICU resident, APN or hospitalist; and one to two subspecialty attendings)
Exclusion Criteria:
Exclusion criteria for parents of case patients:
Exclusion criteria for Healthcare Team members:
-Healthcare team member that does not regularly care for patients in the PICU.
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| Name | Affiliation | Role |
|---|---|---|
| Kelly N Michelson, MD | Ann & Robert H. Lurie Childrens Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States | ||
| The University of Chicago Medicine Comer Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38727516 | Derived | Ashworth RC, Malone JR, Franklin D, Sorce LR, Clayman ML, Frader J, White DB, Michelson KN. Associations of Patient and Parent Characteristics With Parental Decision Regret in the PICU: A Secondary Analysis of the 2015-2017 Navigate Randomized Comparative Trial. Pediatr Crit Care Med. 2024 Sep 1;25(9):795-803. doi: 10.1097/PCC.0000000000003534. Epub 2024 May 10. | |
| 37889100 |
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| ID | Title | Description |
|---|---|---|
| FG000 | PICU Supports | Participants will receive the PICU Supports intervention. PICU Supports: The PICU Supports intervention includes navigator activities and ancillary tools. The Navigator activities include: initial visits with the healthcare team members (HTMs) and parents; weekday visits with the parents and feedback to the HTMs as needed; coordination of weekly family meetings between the parents and HTMs; and support during transitions out of the unit. The ancillary tools include: a PICU handbook; a place for parents to keep track of events and their goals; a provider sheet to inform PICU HTMs about important parental issues, concerns or goals; a bedside communication log so parents know which non-PICU HTMs have visited; an end-of-life checklist; a bereavement packet for those whose child dies; and informational resources. |
| FG001 | Educational Brochure | Participants will receive an educational brochure about the pediatric intensive care unit. Educational Brochure: Parents will receive a short educational brochure with information about the pediatric intensive care unit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PICU Supports | Participants will receive the PICU Supports intervention. PICU Supports: The PICU Supports intervention includes navigator activities and ancillary tools. The Navigator activities include: initial visits with the healthcare team members (HTMs) and parents; weekday visits with the parents and feedback to the HTMs as needed; coordination of weekly family meetings between the parents and HTMs; and support during transitions out of the unit. The ancillary tools include: a PICU handbook; a place for parents to keep track of events and their goals; a provider sheet to inform PICU HTMs about important parental issues, concerns or goals; a bedside communication log so parents know which non-PICU HTMs have visited; an end-of-life checklist; a bereavement packet for those whose child dies; and informational resources. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Satisfaction With Decision Making (Percentage of "Excellent" Scores in the Decision Making Domain of the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire) | Percentage of "excellent" scores in the decision making domain of the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire; minimum=0, maximum=100, higher score is better outcome | Posted | Mean | Standard Error | Percentage of "excellent" scores | 3-5 weeks following PICU discharge |
|
6 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 | PICU Supports | Participants will receive the PICU Supports intervention. PICU Supports: The PICU Supports intervention includes navigator activities and ancillary tools. The Navigator activities include: initial visits with the healthcare team members (HTMs) and parents; weekday visits with the parents and feedback to the HTMs as needed; coordination of weekly family meetings between the parents and HTMs; and support during transitions out of the unit. The ancillary tools include: a PICU handbook; a place for parents to keep track of events and their goals; a provider sheet to inform PICU HTMs about important parental issues, concerns or goals; a bedside communication log so parents know which non-PICU HTMs have visited; an end-of-life checklist; a bereavement packet for those whose child dies; and informational resources. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Rychlik, MS | ChildrensMemorialH | (773) 755-6310 | krychlik@luriechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 6, 2016 | Oct 19, 2018 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| Educational Brochure | Other | Parents will receive a short educational brochure with information about the pediatric intensive care unit. |
|
| Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire) | Subscale: Satisfaction with Care Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire; minimum=0, maximum=100, higher score is better outcome | 3-5 weeks after PICU Discharge |
| Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire) | Subscale: Satisfaction with Decision Making Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire; minimum=0, maximum=100, higher score is better outcome | 3-5 weeks after PICU Discharge |
| Parental Decision Regret (Decision Regret Scale) | Score on the Decision Regret Scale, a 5-item Likert-scale measure of decision regret; minimum=0, maximum=100; higher score indicates more decision regret | 3-5 weeks after PICU discharge |
| Parental Anxiety (Anxiety SF8a) | Score on the Anxiety Short Form8a, a 8-item Likert-scale measure of anxiety, the higher the score, the worst the anxiety, T-score range of 37.1 - 83.1. A T score of 50 is the average fro the US general population. The SD is 10 with a T-score of 60 being 10 worse than the average and a T-score of 40 being 10 better than the average. | 3-5 weeks after PICU discharge |
| Parental Depression (Depression SF8a) | Score on the Depression; Depression Short Form 8a, a 8-item Likert-scale measure of depression; the higher the score, the worst the depression, T-score range of 38.2 - 81.3. A T score of 50 is the average fro the US general population. The SD is 10 with a T-score of 60 being 10 worse than the average and a T-score of 40 being 10 better than the average. | 3-5 weeks after PICU discharge |
| Parental Impact of Event/Post-Traumatic Distress (Impact of Event Scale-revised) | A measure of post-traumatic distress; Score on the Impact of Event Scale-revised, a 22-item Likert-scale measure of post-traumatic distress; scale range from 0 - 88; higher numbers mean higher trauma or distress; units on a scale | 3-5 weeks after PICU discharge |
| Parental Health-related Quality of Life (Global Health Scale) Physical | Measure of global physical health; Physical - Score on the Global Health scale, a 10 item Likert-scale measure of overall health-related quality of life; the higher the score the worse global health, t-score range of 16.2 - 67.7. A T score of 50 is the average fro the US general population. The SD is 10 with a T-score of 60 being 10 worse than the average and a T-score of 40 being 10 better than the average. | 3-5 weeks after PICU discharge |
| Parental Health-related Quality of Life (Global Health Scale) Mental | Measure of Global Mental Health; Mental - Score on the Global Health scale, a 10 item Likert-scale measure of overall health-related quality of life; high scores indicate worse mental health; T-score range 21.1 - 67.6. A T score of 50 is the average fro the US general population. The SD is 10 with a T-score of 60 being 10 worse than the average and a T-score of 40 being 10 better than the average. | 3-5 weeks after PICU discharge |
| Parental Complicated Bereavement (Grief Scale) | Measure of complicated grief in parents after their child's death; Score on the Index of complicated Grief Scale, a 19-item Likert-scale measure of complicated grief; minimum 0, maximum 74; higher numbers mean more complicate grief | 3-5 weeks after PICU discharge |
| Parent Report of Healthcare Team Satisfaction (Collaboration and Satisfaction About Care Decisions Scale) | Measure of Satisfaction with Healthcare team collaboaration Subscale Collaboration Satisfaction Score of the Collaboration and Satisfaction about Care Decisions scale, 2 items on a 9-item Likert-scale measure of healthcare team communication satisfaction in ICUs, Score range from 2 - 14 with higher numbers meaning more satisfaction | 3-5 weeks after PICU Discharge |
| Parent Report of Healthcare Team Collaboration (Collaboration and Satisfaction About Care Decisions Scale) | Subscale Collaboration Score of the Collaboration and Satisfaction about Care Decisions scale, 7 items on a a 9-item Likert-scale measure of healthcare team communication in ICUs, scale range from 7 - 49. Higher numbers more collaboration. | 3-5 weeks after PICU Discharge |
| Parental Report of Acceptability and Perceived Effectiveness of PICU Supports (Likert-scale) | Likert-scale items measuring perceived effectiveness and acceptability of the PICU Supports intervention. One likert scale item based on previous work. White DB, Cua SM, Walk R, et al. Nurse-led intervention to improve surrogate decision making for patients with advanced critical illness. Am J Crit Care. Nov 2012;21(6):396-409. How well did the PICU Supports help with communication in the PICU? scale "Not at all helpful" "Not very helpful" "Somewhat helpful" "Extremely Helpful" "Unable to assess" Scored based on percentage of participants who responded "Somewhat Helpful" or Extremely Helpful" | 3-5 weeks after PICU Discharge |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Tager JB, Hinojosa JT, LiaBraaten BM, Balistreri KA, Aniciete D, Charleston E, Frader JE, White DB, Clayman ML, Sorce LR, Davies WH, Rothschild CB, Michelson KN; Navigate Study Investigators. Challenges of Families of Patients Hospitalized in the PICU: A Preplanned Secondary Analysis From the Navigate Dataset. Pediatr Crit Care Med. 2024 Feb 1;25(2):128-138. doi: 10.1097/PCC.0000000000003385. Epub 2023 Oct 27. |
| BG001 | Educational Brochure | Participants will receive an educational brochure about the pediatric intensive care unit. Educational Brochure: Parents will receive a short educational brochure with information about the pediatric intensive care unit. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | 3 missing from PICU Supports 4 missing from Informational Brochure | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Educational Brochure | Participants will receive an educational brochure about the pediatric intensive care unit. Educational Brochure: Parents will receive a short educational brochure with information about the pediatric intensive care unit. |
|
|
|
| Secondary | Pediatric Family Decision Making Satisfaction in the Intensive Care Unit (pFS-ICU) | Measures satisfaction of family who have a child admitted to the Pediatric intensive care unit; Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire mean score, range 0-100, higher score is the better outcome | Posted | Mean | Standard Deviation | score on a scale | 3-5 weeks following PICU discharge |
|
|
|
|
| Secondary | Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire) | Subscale: Satisfaction with Care Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire; minimum=0, maximum=100, higher score is better outcome | Posted | Mean | Standard Deviation | score on a scale | 3-5 weeks after PICU Discharge |
|
|
|
|
| Secondary | Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire) | Subscale: Satisfaction with Decision Making Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire; minimum=0, maximum=100, higher score is better outcome | Posted | Mean | Standard Deviation | score on a scale | 3-5 weeks after PICU Discharge |
|
|
|
|
| Secondary | Parental Decision Regret (Decision Regret Scale) | Score on the Decision Regret Scale, a 5-item Likert-scale measure of decision regret; minimum=0, maximum=100; higher score indicates more decision regret | Posted | Mean | Standard Deviation | score on a scale | 3-5 weeks after PICU discharge |
|
|
|
|
| Secondary | Parental Anxiety (Anxiety SF8a) | Score on the Anxiety Short Form8a, a 8-item Likert-scale measure of anxiety, the higher the score, the worst the anxiety, T-score range of 37.1 - 83.1. A T score of 50 is the average fro the US general population. The SD is 10 with a T-score of 60 being 10 worse than the average and a T-score of 40 being 10 better than the average. | Posted | Mean | Standard Deviation | score on a scale | 3-5 weeks after PICU discharge |
|
|
|
|
| Secondary | Parental Depression (Depression SF8a) | Score on the Depression; Depression Short Form 8a, a 8-item Likert-scale measure of depression; the higher the score, the worst the depression, T-score range of 38.2 - 81.3. A T score of 50 is the average fro the US general population. The SD is 10 with a T-score of 60 being 10 worse than the average and a T-score of 40 being 10 better than the average. | Posted | Mean | Standard Deviation | score on a scale | 3-5 weeks after PICU discharge |
|
|
|
| Secondary | Parental Impact of Event/Post-Traumatic Distress (Impact of Event Scale-revised) | A measure of post-traumatic distress; Score on the Impact of Event Scale-revised, a 22-item Likert-scale measure of post-traumatic distress; scale range from 0 - 88; higher numbers mean higher trauma or distress; units on a scale | Posted | Mean | Standard Deviation | score on a scale | 3-5 weeks after PICU discharge |
|
|
|
| Secondary | Parental Health-related Quality of Life (Global Health Scale) Physical | Measure of global physical health; Physical - Score on the Global Health scale, a 10 item Likert-scale measure of overall health-related quality of life; the higher the score the worse global health, t-score range of 16.2 - 67.7. A T score of 50 is the average fro the US general population. The SD is 10 with a T-score of 60 being 10 worse than the average and a T-score of 40 being 10 better than the average. | Posted | Mean | Standard Deviation | score on a scale | 3-5 weeks after PICU discharge |
|
|
|
|
| Secondary | Parental Health-related Quality of Life (Global Health Scale) Mental | Measure of Global Mental Health; Mental - Score on the Global Health scale, a 10 item Likert-scale measure of overall health-related quality of life; high scores indicate worse mental health; T-score range 21.1 - 67.6. A T score of 50 is the average fro the US general population. The SD is 10 with a T-score of 60 being 10 worse than the average and a T-score of 40 being 10 better than the average. | Posted | Mean | Standard Deviation | score on a scale | 3-5 weeks after PICU discharge |
|
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|
|
| Secondary | Parental Complicated Bereavement (Grief Scale) | Measure of complicated grief in parents after their child's death; Score on the Index of complicated Grief Scale, a 19-item Likert-scale measure of complicated grief; minimum 0, maximum 74; higher numbers mean more complicate grief | Data from only 4 participants are analyzed because only 4 people whose children died responded to surveys. 3 participants were in the PICU Support arm and 1 in the Educational Brochure Arm. These data are not shown in the Participant Flow Module because of the small numbers. | Posted | Mean | Full Range | score on a scale | 3-5 weeks after PICU discharge |
|
|
|
| Secondary | Parent Report of Healthcare Team Satisfaction (Collaboration and Satisfaction About Care Decisions Scale) | Measure of Satisfaction with Healthcare team collaboaration Subscale Collaboration Satisfaction Score of the Collaboration and Satisfaction about Care Decisions scale, 2 items on a 9-item Likert-scale measure of healthcare team communication satisfaction in ICUs, Score range from 2 - 14 with higher numbers meaning more satisfaction | Posted | Mean | Standard Deviation | score on a scale | 3-5 weeks after PICU Discharge |
|
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|
|
| Secondary | Parent Report of Healthcare Team Collaboration (Collaboration and Satisfaction About Care Decisions Scale) | Subscale Collaboration Score of the Collaboration and Satisfaction about Care Decisions scale, 7 items on a a 9-item Likert-scale measure of healthcare team communication in ICUs, scale range from 7 - 49. Higher numbers more collaboration. | Posted | Mean | Standard Deviation | score on a scale | 3-5 weeks after PICU Discharge |
|
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|
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| Secondary | Parental Report of Acceptability and Perceived Effectiveness of PICU Supports (Likert-scale) | Likert-scale items measuring perceived effectiveness and acceptability of the PICU Supports intervention. One likert scale item based on previous work. White DB, Cua SM, Walk R, et al. Nurse-led intervention to improve surrogate decision making for patients with advanced critical illness. Am J Crit Care. Nov 2012;21(6):396-409. How well did the PICU Supports help with communication in the PICU? scale "Not at all helpful" "Not very helpful" "Somewhat helpful" "Extremely Helpful" "Unable to assess" Scored based on percentage of participants who responded "Somewhat Helpful" or Extremely Helpful" | 91.1% (113/124) reported PICU Supports as "extremely" or "somewhat" helpful. | Posted | Count of Participants | Participants | 3-5 weeks after PICU Discharge |
|
|
|
| 0 |
| 124 |
| 0 |
| 124 |
| 0 |
| 124 |
| EG001 | Educational Brochure | Participants will receive an educational brochure about the pediatric intensive care unit. Educational Brochure: Parents will receive a short educational brochure with information about the pediatric intensive care unit. | 0 | 117 | 0 | 117 | 0 | 117 |
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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 |
|
| Unknown or Not Reported |
|