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slow enrollment
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The purpose of this study is to evaluate, through a randomized controlled trial, the impact of integrated comprehensive palliative care services on time to first hospital readmission and other hospital utilization outcomes, quality of life, and patient/caregiver outcomes. The intervention includes comprehensive, standardized palliative care services for adult hepatology cirrhosis patients for which prognosis is poor.
Palliative care is specialized medical care focused on providing patients with relief from the symptoms, pain, and stress of serious or life-limiting illness, regardless of diagnosis, by anticipating, preventing, and treating suffering. Palliative care aims to provide patients and their families with services to help patients make the best possible medical decisions in the face of serious illness. Unfortunately it is often thought to be synonymous with hospice care and therefore underutilized as a part of standard care. Patients with chronic liver disease or cirrhosis may be a particularly underserved population for palliative care, as palliative care may be disregarded until hope of liver transplantation is lost.
Study Description:
Specific aims include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comprehensive Palliative Care services | Other | Comprehensive Palliative Care services in addition to usual hepatic care |
|
| Usual hepatic care | Other | Usual hepatic care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Palliative Care services | Other | Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Hospital Readmission Within 6 Months Post-randomization | Assess the impact of palliative care services on time to first hospital readmission. Time frame was changed from 1 year to 6 months due to early termination. | 6 months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Days Alive Out of Hospital | Days alive out of hospital from randomization to 6 months post randomization compared across arms. Time frame was changed from 1 year to 6 months due to early termination. | 6 months post-randomization |
| Total Days in Hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gordon Bernard, MD | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Comprehensive Palliative Care Services | Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart. |
| FG001 | Usual Hepatic Care | Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Comprehensive Palliative Care Services | Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart. |
| 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 | Time to First Hospital Readmission Within 6 Months Post-randomization | Assess the impact of palliative care services on time to first hospital readmission. Time frame was changed from 1 year to 6 months due to early termination. | 5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis. | Posted | Median | Inter-Quartile Range | days | 6 months post-randomization |
|
baseline to 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 | Comprehensive Palliative Care Services | Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cheryl Gatto | Vanderbilt University Medical Center | 6153432252 | cheryl.l.gatto.1@vumc.org |
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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 7, 2017 | Aug 2, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005234 | Fatty Liver |
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|
| Usual hepatic care | Other | Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations. |
|
Total days in hospital from randomization to 6 months post randomization compared across arms Time frame was changed from 1 year to 6 months due to early termination. |
| 6 months post-randomization |
| Total Days in ICU | Total days in ICU from randomization to 6 months post randomization compared across arms. Time frame was changed from 1 year to 6 months due to early termination. | 6 months post-randomization |
| Number of Hospital Readmissions | Number of hospital readmissions from randomization to 6 months post randomization compared across arms. Time frame was changed from 1 year to 6 months due to early termination. | 6 months post-randomization |
| Median Length of Hospital Stay Per Admission | Median length of hospital stay per admission from randomization to 6 months post randomization compared across arms. Time frame was changed from 1 year to 6 months due to early termination. | 6 months post-randomization |
| Hospice Referral | Number of transfers to hospice within 6 months post randomization compared across arms. Time frame was changed from 1 year to 6 months due to early termination. | 6 months post-randomization |
| Time to Hospice Placement | Number of days from hospice referral to time to hospice placement. Time frame was changed from 1 year to 6 months due to early termination. There are only 3 patients with a hospice admission date that is after baseline discharge, all of whom are from the control group. The remaining patients with hospice referral but are missing a hospice admission date due to death before hospice admission. Therefore, it is not feasible to calculate any statistics. | 6 months post-randomization |
| Change in Chronic Liver Disease Questionnaire (CLDQ) | Change in liver disease-related quality of life: The CLDQ is a 29-item questionnaire measuring 6 domains. Item scores range from 1 to 7 with higher scores indicating better quality of life. The total score can range from 29 to 203 with a score of 1 meaning the symptom being assessed is "present always" while a score of 7 means the symptom is "never present". Therefore, a higher score corresponds to a better quality of life while a lower score corresponds to a worse quality of life. The questions in each domain have a range of factor loads indicative of their impact, and a clinically important difference is defined as a score change of 0.5. Time frame was changed from 1 year to 6 months due to early termination. | Change from baseline over 6 months post-randomization |
| Change in EQ-5D-5L | Change in generic health status: The EQ-5D-5L is a 5-item questionnaire with responses ranging from absence of symptom to extreme experience of the symptom. This scale is numbered from 0 to 100. 100 means the best health you can imagine and 0 means the worst health you can imagine. Time frame was changed from 1 year to 6 months due to early termination. | Change from baseline over 6 months post-randomization |
| Change in PROMIS Emotional Distress - Anxiety - Short Form 4a | Change in mood (anxiety): The PROMIS Emotional Distress - Anxiety - Short Form 4a contains 4 items that measure anxiety on a 5-point Likert scale with higher scores indicating increased symptomatology. The raw score can range from 4 to 20 which converts to a t-score range of 40.3 to 81.6. Time frame was changed from 1 year to 6 months due to early termination. | Change from baseline over 6 months post-randomization |
| Change in PROMIS Emotional Distress - Depression - Short Form 4a | Change in mood (depression): The PROMIS Emotional Distress - Depression - Short Form 4a contains 4 items that measure depression on a 5-point Likert scale with higher scores indicating increased symptomatology. The raw score ranges from 4 to 20 which converts to a t-score range of 41.0 to 79.4. Time frame was changed from 1 year to 6 months due to early termination. | Change from baseline over 6 months post-randomization |
| Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient) | Change in patient satisfaction with care: The Quality of End-of-Life Care: Questionnaire for Patient is an 11-item questionnaire, with items scored on a 10-point Likert type scale with higher scores indicating better satisfaction with care. The score can range from 0 to 110. Time frame was changed from 1 year to 6 months due to early termination. | Change from baseline over 6 months post-randomization |
| Change in Kingston Caregiver Stress Scale | The Kingston Caregiver Stress Scale will be used to measure caregiver stress. The KCSS is designed to measure stress experienced by lay caregivers, not institutional staff, and was designed to monitor change in an individuals stress over time. Ten items are grouped into three categories: care giving, family, and financial issues. Scores can range from 10 to 50. Lower scores indicate less stress and higher scores indicate high stress. Time frame was changed from 1 year to 6 months due to early termination. | Change from baseline over 6 months post-randomization |
| Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient Adapted for Caregiver) | Change in caregiver satisfaction with care: The Quality of End-of-Life Care: Questionnaire for Patient item wording was modified to apply to caregivers. The questionnaire is an 11-item questionnaire, with items scored on a 10-point Likert type scale with higher scores indicating better quality of care. The score can range from 0 to 110. Time frame was changed from 1 year to 6 months due to early termination. | Change from baseline over 6 months post-randomization |
| Liver Transplant Status | Number of deferred, listed, and declined listing for liver transplant compared across arms. Time frame was changed from 1 year to 6 months due to early termination. Liver transplant status data was not obtained. | 6 months post-randomization |
| Model for End-Stage Liver Disease (MELD) Score | Baseline MELD score compared across arms. MELD score ranks the participants degree of sickness and indicates how much the participant needs a liver transplant. The score ranges from 6-40. The higher the number the more urgent the need for a transplant. | Baseline |
| Completed Liver Transplants | Number of patients with completed liver transplants compared across arms. Time frame was changed from 1 year to 6 months due to early termination. | 6 months post-randomization |
| Physical Symptoms | Number of documented physical symptoms (ascites, variceal bleeding, encephalopathy, etc.) compared across arms. Time frame was changed from 1 year to 6 months due to early termination. Physical symptom data was not obtained. | 6 months post-randomization |
| Presence of Advance Directives | Percentage of patients with documented advance care directives compared across arms. Time frame was changed from 1 year to 6 months due to early termination. | 6 months post-randomization |
| Survival | Survival rate compared across arms. Time frame was changed from 1 year to 6 months due to early termination. | 6 months post-randomization |
| Provider Satisfaction | The "ICU Provider Satisfaction Survey with the Palliative Care Program:Veterans Affairs of Ann Arbor" instrument is available online and has been modified for the current study by removing the 'ICU' reference and revising 'pain' to symptoms more relevant to the current population. The survey includes 7-item questionnaire, with items scored on a 5-point Likert type scale with higher scores indicating better provider satisfaction. The score can range from 0 to 35. Time frame was changed due to early termination. Data was not collected. | Change from Baseline to study closeout. |
| BG001 | Usual Hepatic Care | Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations. |
| BG002 | 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 Hepatic Care | Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations. |
|
|
| Secondary | Days Alive Out of Hospital | Days alive out of hospital from randomization to 6 months post randomization compared across arms. Time frame was changed from 1 year to 6 months due to early termination. | 5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis. | Posted | Median | Inter-Quartile Range | days | 6 months post-randomization |
|
|
|
| Secondary | Total Days in Hospital | Total days in hospital from randomization to 6 months post randomization compared across arms Time frame was changed from 1 year to 6 months due to early termination. | 5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis. | Posted | Median | Inter-Quartile Range | days | 6 months post-randomization |
|
|
|
| Secondary | Total Days in ICU | Total days in ICU from randomization to 6 months post randomization compared across arms. Time frame was changed from 1 year to 6 months due to early termination. | 5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis. | Posted | Count of Participants | Participants | 6 months post-randomization |
|
|
|
| Secondary | Number of Hospital Readmissions | Number of hospital readmissions from randomization to 6 months post randomization compared across arms. Time frame was changed from 1 year to 6 months due to early termination. | 5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis. | Posted | Count of Participants | Participants | 6 months post-randomization |
|
|
|
| Secondary | Median Length of Hospital Stay Per Admission | Median length of hospital stay per admission from randomization to 6 months post randomization compared across arms. Time frame was changed from 1 year to 6 months due to early termination. | The sample size indicates number of hospital readmissions per study arm. | Posted | Median | Inter-Quartile Range | days per admission | 6 months post-randomization |
|
|
|
| Secondary | Hospice Referral | Number of transfers to hospice within 6 months post randomization compared across arms. Time frame was changed from 1 year to 6 months due to early termination. | 5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis. | Posted | Count of Participants | Participants | 6 months post-randomization |
|
|
|
| Secondary | Time to Hospice Placement | Number of days from hospice referral to time to hospice placement. Time frame was changed from 1 year to 6 months due to early termination. There are only 3 patients with a hospice admission date that is after baseline discharge, all of whom are from the control group. The remaining patients with hospice referral but are missing a hospice admission date due to death before hospice admission. Therefore, it is not feasible to calculate any statistics. | There are only 3 patients with a hospice admission date that is after baseline discharge, all of whom are from the control group. The remaining patients with hospice referral but are missing a hospice admission date due to death before hospice admission. Therefore, it is not feasible to calculate any statistics. | Posted | Count of Participants | Participants | 6 months post-randomization |
|
|
|
| Secondary | Change in Chronic Liver Disease Questionnaire (CLDQ) | Change in liver disease-related quality of life: The CLDQ is a 29-item questionnaire measuring 6 domains. Item scores range from 1 to 7 with higher scores indicating better quality of life. The total score can range from 29 to 203 with a score of 1 meaning the symptom being assessed is "present always" while a score of 7 means the symptom is "never present". Therefore, a higher score corresponds to a better quality of life while a lower score corresponds to a worse quality of life. The questions in each domain have a range of factor loads indicative of their impact, and a clinically important difference is defined as a score change of 0.5. Time frame was changed from 1 year to 6 months due to early termination. | Only 5 participants in each group returned both the baseline and 6-month surveys. | Posted | Median | Inter-Quartile Range | score on a scale | Change from baseline over 6 months post-randomization |
|
|
|
| Secondary | Change in EQ-5D-5L | Change in generic health status: The EQ-5D-5L is a 5-item questionnaire with responses ranging from absence of symptom to extreme experience of the symptom. This scale is numbered from 0 to 100. 100 means the best health you can imagine and 0 means the worst health you can imagine. Time frame was changed from 1 year to 6 months due to early termination. | Only 5 participants from each group returned both baseline and 6-month surveys. | Posted | Median | Inter-Quartile Range | score on a scale | Change from baseline over 6 months post-randomization |
|
|
|
| Secondary | Change in PROMIS Emotional Distress - Anxiety - Short Form 4a | Change in mood (anxiety): The PROMIS Emotional Distress - Anxiety - Short Form 4a contains 4 items that measure anxiety on a 5-point Likert scale with higher scores indicating increased symptomatology. The raw score can range from 4 to 20 which converts to a t-score range of 40.3 to 81.6. Time frame was changed from 1 year to 6 months due to early termination. | Only 5 participants from each group returned both baseline and 6-month surveys. | Posted | Median | Inter-Quartile Range | score on a scale | Change from baseline over 6 months post-randomization |
|
|
|
| Secondary | Change in PROMIS Emotional Distress - Depression - Short Form 4a | Change in mood (depression): The PROMIS Emotional Distress - Depression - Short Form 4a contains 4 items that measure depression on a 5-point Likert scale with higher scores indicating increased symptomatology. The raw score ranges from 4 to 20 which converts to a t-score range of 41.0 to 79.4. Time frame was changed from 1 year to 6 months due to early termination. | Only 4 participants from the comprehensive palliative care services each group and 5 participants from the usual hepatic care group returned both baseline and 6-month surveys. | Posted | Median | Inter-Quartile Range | score on a scale | Change from baseline over 6 months post-randomization |
|
|
|
| Secondary | Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient) | Change in patient satisfaction with care: The Quality of End-of-Life Care: Questionnaire for Patient is an 11-item questionnaire, with items scored on a 10-point Likert type scale with higher scores indicating better satisfaction with care. The score can range from 0 to 110. Time frame was changed from 1 year to 6 months due to early termination. | Only 5 participants from the comprehensive palliative care services each group and 4 participants from the usual hepatic care group returned both baseline and 6-month surveys. | Posted | Median | Inter-Quartile Range | score on a scale | Change from baseline over 6 months post-randomization |
|
|
|
| Secondary | Change in Kingston Caregiver Stress Scale | The Kingston Caregiver Stress Scale will be used to measure caregiver stress. The KCSS is designed to measure stress experienced by lay caregivers, not institutional staff, and was designed to monitor change in an individuals stress over time. Ten items are grouped into three categories: care giving, family, and financial issues. Scores can range from 10 to 50. Lower scores indicate less stress and higher scores indicate high stress. Time frame was changed from 1 year to 6 months due to early termination. | The intended population included caregivers. There is no statistics to report. The two scores from participants in the intervention group are indicated below. | Posted | Count of Participants | Participants | Change from baseline over 6 months post-randomization |
|
|
|
| Secondary | Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient Adapted for Caregiver) | Change in caregiver satisfaction with care: The Quality of End-of-Life Care: Questionnaire for Patient item wording was modified to apply to caregivers. The questionnaire is an 11-item questionnaire, with items scored on a 10-point Likert type scale with higher scores indicating better quality of care. The score can range from 0 to 110. Time frame was changed from 1 year to 6 months due to early termination. | The intended population includes the caregivers. Only one caregiver in each group returned both surveys. | Posted | Median | Inter-Quartile Range | score on a scale | Change from baseline over 6 months post-randomization |
|
|
|
| Secondary | Liver Transplant Status | Number of deferred, listed, and declined listing for liver transplant compared across arms. Time frame was changed from 1 year to 6 months due to early termination. Liver transplant status data was not obtained. | Liver transplant status data was not obtained. | Posted | 6 months post-randomization |
|
|
| Secondary | Model for End-Stage Liver Disease (MELD) Score | Baseline MELD score compared across arms. MELD score ranks the participants degree of sickness and indicates how much the participant needs a liver transplant. The score ranges from 6-40. The higher the number the more urgent the need for a transplant. | Baseline MELD scores were only available for 26 intervention group participants and 27 control group participants. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
|
|
|
| Secondary | Completed Liver Transplants | Number of patients with completed liver transplants compared across arms. Time frame was changed from 1 year to 6 months due to early termination. | 5 participants withdrew from the usual hepatic care group. | Posted | Count of Participants | Participants | 6 months post-randomization |
|
|
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| Secondary | Physical Symptoms | Number of documented physical symptoms (ascites, variceal bleeding, encephalopathy, etc.) compared across arms. Time frame was changed from 1 year to 6 months due to early termination. Physical symptom data was not obtained. | Physical symptom data was not obtained. | Posted | 6 months post-randomization |
|
|
| Secondary | Presence of Advance Directives | Percentage of patients with documented advance care directives compared across arms. Time frame was changed from 1 year to 6 months due to early termination. | 5 participants withdrew from the usual hepatic care group. | Posted | Count of Participants | Participants | 6 months post-randomization |
|
|
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| Secondary | Survival | Survival rate compared across arms. Time frame was changed from 1 year to 6 months due to early termination. | 5 participants withdrew from the usual hepatic care group. | Posted | Count of Participants | Participants | 6 months post-randomization |
|
|
|
| Secondary | Provider Satisfaction | The "ICU Provider Satisfaction Survey with the Palliative Care Program:Veterans Affairs of Ann Arbor" instrument is available online and has been modified for the current study by removing the 'ICU' reference and revising 'pain' to symptoms more relevant to the current population. The survey includes 7-item questionnaire, with items scored on a 5-point Likert type scale with higher scores indicating better provider satisfaction. The score can range from 0 to 35. Time frame was changed due to early termination. Data was not collected. | The provider population was not analyzed because data was not collected. | Posted | Change from Baseline to study closeout. |
|
|
| 9 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Usual Hepatic Care | Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations. | 7 | 32 | 0 | 32 | 0 | 32 |
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| 2 ICU days |
|
| 6 ICU days |
|
| 7 ICU days |
|
| 9 ICU days |
|
| 2 readmissions |
|
| 3 readmissions |
|
| 4 readmissions |
|
| 5 readmissions |
|