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| ID | Type | Description | Link |
|---|---|---|---|
| 3R01NR017018 | U.S. NIH Grant/Contract | View source | |
| 5R01AG057714 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| National Institute on Aging (NIA) | NIH |
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In this study, 30 patient and caregiver dyads will be randomized to receive the SPIRIT-dementia intervention or usual care. Participants will be follow-up with 2-3 days after the intervention to evaluate the impact of SPIRIT on preparedness outcomes. Additional follow up with caregivers will occur 6 months later.
Cognitive impairment or dementia, usually vascular dementia or Alzheimer's, co-occur in approximately 38% of patients with end stage renal disease (ESRD). When dementia is superimposed on ESRD, the risk for poor outcomes, including disability, hospitalization and death, sharply increases. Similarly, initiating dialysis in older adults with multiple comorbidities, including dementia, does not offer survival benefit. However, advance care planning (ACP) discussions with dialysis patients rarely occur. The reality of ESRD plus dementia is that most of these patients are likely to die or progress to advanced dementia without ever engaging in ACP discussions before the cognitive window of opportunity closes. Moreover, persons with dementia (regardless of their cognitive impairment level) are routinely excluded from clinical trials of ACP, largely because investigators assume that these people do not have the cognitive capability to appreciate the complexity of ACP. In an on-going study ("SPIRIT in Dementia") the researchers carefully adapted SPIRIT for persons with mild to moderate dementia (mostly due to Alzheimer's) and their surrogates. In a sample of 23 dementia patients without complex multimorbidity and their surrogates, the researchers were able to conclude that meaningful ACP conversations were possible even for individuals with moderate dementia. Based on these findings, this supplement study will leverage the infrastructure of the parent SPIRIT in ESRD trial to pilot test the adapted SPIRIT intervention for patients with ESRD plus dementia as a model for determining whether patients with dementia superimposed on complex multimorbidity can fully participate in ACP discussion.
This purpose of this pilot randomized controlled trial with 30 patient and caregiver dyads is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPIRIT-Dementia | Experimental | Patients and their surrogates randomized to this study arm will receive the SPIRIT-dementia intervention. |
|
| Usual Care | Active Comparator | Patients and surrogates randomized to this study arm will receive the standard information about advance directives that is provided at the time of diagnosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPIRIT-Dementia | Behavioral | The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Dyad Congruence | Dyad congruence will be assessed using the Goals-of-Care Tool which includes two scenarios describing medical conditions commonly occurring in ESRD patients. Possible responses to the scenarios are: "The goals of care should focus on delaying my death, and thus I want to continue life-sustaining treatment", "The goals of care should focus on my comfort and peace, and thus I do not want life-sustaining treatment, including dialysis", and "I am not sure". Patients and surrogates complete this tool independently and their responses are then compared to determine dyad congruence. | Baseline, 2 Days Post-intervention |
| Patient's Decisional Conflict Scale (DCS) Score | Patient decisional conflict will be measured using the 13-item Decisional Conflict Scale (DCS), a validated measure in the context of end-of-life decision making. Participants indicate their level of agreement with statements about their plans for their future medical care by selecting (1) Strongly Agree, (2) Agree, (3) Neither Agree nor Disagree, (4) Disagree, or (5) Strongly Disagree. The total score ranges from 13 - 65 with higher scores indicating greater difficulty in weighing benefits and burdens of life-sustaining treatments and decision making. | Baseline, 2 Days Post-intervention |
| Surrogate's Decision Making Confidence (DMC) Scale Score | Surrogate decision-making confidence will be measured using the 5-item Decision Making Confidence (DMC) scale. Surrogates indicate how confident they are about making medical decisions if the patient becomes unable to make their own decisions by their level of agreement with statements along a scale of (0) "Not confident at all" to (5) "Very confident". Total scores range from 0 - 20, with higher scores indicating greater confidence. | Baseline, 2 Days Post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment) | The proportion of decisions (participants who withdrew from dialysis, Do not resuscitate (DNR), or chose hospice enrollment) will be compared between study arms. | 6 and 12 Months Post-intervention |
| Surrogate's Anxiety-Score Using the Hospital Anxiety and Depression Scale (HADS) Score |
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Patient Inclusion Criteria:
Exclusion Criteria:
Surrogate Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mi-Kyung Song, RN, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Dialysis at Northside | Atlanta | Georgia | 30318 | United States | ||
| Emory Dialysis at Greenbriar |
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Research team chose individual randomization because intervention spillover to the control condition was very unlikely. Race was used (white vs non-white) as stratification factor to ensure equal allocation of race to each condition to control for race as a confounder. Intervention was delivered by a trained interventionist, in person, or virtually due to COVID-19, and thus it was nearly impossible for care providers to obtain the knowledge and skill related to SPIRIT to change their practice.
Participants were recruited from multiple dialysis centers in Georgia, USA. Participant enrollment began on February 14, 2020, and follow-up assessments for the primary outcome measures were completed on March 24, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | SPIRIT-Dementia -Patients | Patients and their surrogates randomized to this study arm will receive the SPIRIT-dementia intervention. SPIRIT-Dementia: The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, an opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care. |
| FG001 | SPIRIT-Dementia -Surrogate | Surrogates of patients randomized to this study arm will receive the SPIRIT-dementia intervention. SPIRIT-Dementia: The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, an opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care. |
| FG002 | Usual Care - Patients | Patients and surrogates randomized to this study arm will receive the standard information about advance directives that are provided at the time of diagnosis. Usual Care: As required by the Centers for Medicare and Medicaid Services (CMS) written information on advance directives is provided to a patient on the first day of dialysis, and a social worker reviews this information with patients and encourages them to complete an advance directive. |
| FG003 | Usual Care - Surrogates | Surrogates of patients randomized to this study arm will receive the standard information about advance directives that are provided at the time of diagnosis. Usual Care: As required by the Centers for Medicare and Medicaid Services (CMS) written information on advance directives is provided to a patient on the first day of dialysis, and a social worker reviews this information with patients and encourages them to complete an advance directive. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SPIRIT-Dementia -Patients | Patients and their surrogates randomized to this study arm will receive the SPIRIT-dementia intervention. SPIRIT-Dementia: The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, an opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care. |
| 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 | Dyad Congruence | Dyad congruence will be assessed using the Goals-of-Care Tool which includes two scenarios describing medical conditions commonly occurring in ESRD patients. Possible responses to the scenarios are: "The goals of care should focus on delaying my death, and thus I want to continue life-sustaining treatment", "The goals of care should focus on my comfort and peace, and thus I do not want life-sustaining treatment, including dialysis", and "I am not sure". Patients and surrogates complete this tool independently and their responses are then compared to determine dyad congruence. | The Unit of measure and analysis is a dyad (patient-surrogate pair). At 2 days post-intervention, 2 attrition in the SPIRIT group and 1 attrition in the Comparison group | Posted | Number | Dyads | Baseline, 2 Days Post-intervention |
|
Up to six months after enrollment. Due to the population being examined and the nature of this study, deaths in the patient population are not considered adverse events.
Only adverse events related to the intervention, such as emotional distress, were documented during the intervention session. Due to the population being examined and the nature of this study, deaths are not considered an adverse event in this population, however, known deaths occurring up to the 6-month assessment were documented.
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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 | SPIRIT-Dementia- Patients | Patients and their surrogates randomized to this study arm will receive the SPIRIT-dementia intervention. SPIRIT-Dementia: The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Mi-Kyung Song, PhD, RN | Emory University | 404-727-3134 | mi-kyung.song@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2021 | Apr 19, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 10, 2020 | Apr 14, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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30 pairs of patients and their caregivers (surrogates) will be randomized to either receive the SPIRIT intervention or standard of care.
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|
| Usual Care | Behavioral | As required by Centers for Medicare and Medicaid Services (CMS) written information on advance directives is provided to a patient on the first day of dialysis, and a social worker reviews this information with patients and encourages them to complete an advance directive. |
|
Surrogate post-bereavement anxiety and depressive symptoms will be measured with the Hospital Anxiety and Depression Scale (HADS). Surrogates indicate their level of agreement with statements by selecting responses rated from 0 (the problem in the statement is not an issue) to 3 (the problem in the statement is a very big issue). The separate anxiety and depression subscale scores range from 0 to 21 with higher scores indicating greater symptom severity. A score of 0-7 indicates "normal", 8-10 indicates "borderline abnormal", and 11-21 indicates "abnormal" levels of anxiety or depression. |
| Baseline, 1 Month after the Patient's Death |
| Surrogate's Depression-Score by Using the Hospital Anxiety and Depression Scale (HADS) Score | Surrogate post-bereavement anxiety and depressive symptoms will be measured with the Hospital Anxiety and Depression Scale (HADS). Surrogates indicate their level of agreement with statements by selecting responses rated from 0 (the problem in the statement is not an issue) to 3 (the problem in the statement is a very big issue). The separate anxiety and depression subscale scores range from 0 to 21 with higher scores indicating greater symptom severity. A score of 0-7 indicates "normal", 8-10 indicates "borderline abnormal", and 11-21 indicates "abnormal" levels of anxiety or depression. | Baseline, 1 Month after the Patient's Death |
| Atlanta |
| Georgia |
| 30331 |
| United States |
| Emory Dialysis at North Decatur | Decatur | Georgia | 30033 | United States |
| Emory Dialysis at Candler | Decatur | Georgia | 30034 | United States |
| Withdrawal by Subject |
|
| Death of surrogate partner |
|
| BG001 | SPIRIT-Dementia -Surrogate | Surrogates of patients randomized to this study arm will receive the SPIRIT-dementia intervention. SPIRIT-Dementia: The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, an opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care. |
| BG002 | Usual Care - Patients | Patients and surrogates randomized to this study arm will receive the standard information about advance directives that are provided at the time of diagnosis. Usual Care: As required by the Centers for Medicare and Medicaid Services (CMS) written information on advance directives is provided to a patient on the first day of dialysis, and a social worker reviews this information with patients and encourages them to complete an advance directive. |
| BG003 | Usual Care - Surrogates | Surrogates of patients randomized to this study arm will receive the standard information about advance directives that are provided at the time of diagnosis. Usual Care: As required by the Centers for Medicare and Medicaid Services (CMS) written information on advance directives is provided to a patient on the first day of dialysis, and a social worker reviews this information with patients and encourages them to complete an advance directive. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Usual Care | Patients and surrogates randomized to this study arm will receive the standard information about advance directives that is provided at the time of diagnosis. Usual Care: As required by Centers for Medicare and Medicaid Services (CMS) written information on advance directives is provided to a patient on the first day of dialysis, and a social worker reviews this information with patients and encourages them to complete an advance directive. |
|
|
| Primary | Patient's Decisional Conflict Scale (DCS) Score | Patient decisional conflict will be measured using the 13-item Decisional Conflict Scale (DCS), a validated measure in the context of end-of-life decision making. Participants indicate their level of agreement with statements about their plans for their future medical care by selecting (1) Strongly Agree, (2) Agree, (3) Neither Agree nor Disagree, (4) Disagree, or (5) Strongly Disagree. The total score ranges from 13 - 65 with higher scores indicating greater difficulty in weighing benefits and burdens of life-sustaining treatments and decision making. | This analysis includes participants (patients) who completed the indicated study visit. Two participants (patients) in the SPIRIT group and one participant (patient) in the Comparison group did not complete the 2-day post-intervention follow-up visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 Days Post-intervention |
|
|
|
| Primary | Surrogate's Decision Making Confidence (DMC) Scale Score | Surrogate decision-making confidence will be measured using the 5-item Decision Making Confidence (DMC) scale. Surrogates indicate how confident they are about making medical decisions if the patient becomes unable to make their own decisions by their level of agreement with statements along a scale of (0) "Not confident at all" to (5) "Very confident". Total scores range from 0 - 20, with higher scores indicating greater confidence. | This analysis includes participants who completed study visits. There were two attrition (surrogates) in the SPIRIT group and one (surrogate) attrition in the Comparison group At 2 days post-intervention | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 Days Post-intervention |
|
|
|
| Secondary | Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment) | The proportion of decisions (participants who withdrew from dialysis, Do not resuscitate (DNR), or chose hospice enrollment) will be compared between study arms. | At both 6 and 12 months post-intervention, 2 attrition in the SPIRIT group and 2 attrition in the Comparison group | Posted | Count of Participants | Participants | 6 and 12 Months Post-intervention |
|
|
|
| Secondary | Surrogate's Anxiety-Score Using the Hospital Anxiety and Depression Scale (HADS) Score | Surrogate post-bereavement anxiety and depressive symptoms will be measured with the Hospital Anxiety and Depression Scale (HADS). Surrogates indicate their level of agreement with statements by selecting responses rated from 0 (the problem in the statement is not an issue) to 3 (the problem in the statement is a very big issue). The separate anxiety and depression subscale scores range from 0 to 21 with higher scores indicating greater symptom severity. A score of 0-7 indicates "normal", 8-10 indicates "borderline abnormal", and 11-21 indicates "abnormal" levels of anxiety or depression. | The surrogate in the SPIRIT group did not complete the post-bereavement assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 Month after the Patient's Death |
|
|
|
| Secondary | Surrogate's Depression-Score by Using the Hospital Anxiety and Depression Scale (HADS) Score | Surrogate post-bereavement anxiety and depressive symptoms will be measured with the Hospital Anxiety and Depression Scale (HADS). Surrogates indicate their level of agreement with statements by selecting responses rated from 0 (the problem in the statement is not an issue) to 3 (the problem in the statement is a very big issue). The separate anxiety and depression subscale scores range from 0 to 21 with higher scores indicating greater symptom severity. A score of 0-7 indicates "normal", 8-10 indicates "borderline abnormal", and 11-21 indicates "abnormal" levels of anxiety or depression. | The surrogate in the SPIRIT group did not complete the post-bereavement assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 Month after the Patient's Death |
|
|
|
| 1 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | SPIRIT-Dementia- Surrogates | Surrogates of patients randomized to this study arm will receive the SPIRIT-dementia intervention. SPIRIT-Dementia: The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care. | 1 | 9 | 0 | 9 | 0 | 9 |
| EG002 | Usual Care - Patients | Patients and surrogates randomized to this study arm will receive the standard information about advance directives that are provided at the time of diagnosis. Usual Care: As required by the Centers for Medicare and Medicaid Services (CMS) written information on advance directives is provided to a patient on the first day of dialysis, and a social worker reviews this information with patients and encourages them to complete an advance directive. | 1 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Usual Care - Surrogates | Patients and surrogates randomized to this study arm will receive the standard information about advance directives that are provided at the time of diagnosis. Usual Care: As required by the Centers for Medicare and Medicaid Services (CMS) written information on advance directives is provided to a patient on the first day of dialysis, and a social worker reviews this information with patients and encourages them to complete an advance directive. | 1 | 10 | 0 | 10 | 0 | 10 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Two (2) Days Post-Intervention |
|
|
| Two (2) Days Post-Intervention |
|
|
| 6 months post-intervention: Participants who chose Do Not Resuscitate (DNR) |
|
|
| 6 months post-intervention: Participants who chose Hospice enrollment |
|
|
| 12 months post-intervention: Participants who withdrew from dialysis |
|
|
| 12 months post-intervention Participants who chose Do Not Resuscitate (DNR) |
|
|
| 12 months post-intervention: Participants who chose Hospice enrollment |
|
|
| Anxiety - 1 Month after patient' death |
|
|
| Depression - 1 Month after patient' death |
|
|