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| ID | Type | Description | Link |
|---|---|---|---|
| 80736 | Other Grant/Funding Number | Robert Wood Johnson Foundation | |
| 242379 | Other Grant/Funding Number | Cambia Health Foundation | |
| 243432 | Other Grant/Funding Number | American Association for the Study of Liver Diseases | |
| 236965 | Other Grant/Funding Number | Massachusetts General Hospital Executive Committee on Researrch |
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The goal of this clinical trial is to evaluate whether early integration of palliative care in the care of hospitalized patients with advanced liver disease (AdvLD) can improve patients' quality of life, physical symptoms, mood, and serious illness communication. Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.
The main purpose of this study is to compare two types of care - usual hepatology care and usual hepatology care with early involvement of palliative care clinicians to see which is better for improving the experience of hospitalized patients with advanced liver disease (AdvLD).
The investigators aim to find out whether introducing hospitalized patients with AdvLD to the palliative care team that specializes in symptom management can improve the quality of life and physical and psychological symptoms that patients and families experience during their hospitalizations as well as enhance the quality of patients' end of life care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Hepatology Care | No Intervention | Usual hepatology care | |
| Usual Hepatology Care with Early Palliative Care | Experimental | Usual hepatology care with early palliative care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LiverPAL | Behavioral | The intervention include integrating early palliative care with usual hepatology care to evaluate and treat patients' symptoms, enhance their illness and prognostic understanding, support their coping, and coordinate their serious illness, transitional, and end-of-life care. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Quality of Life (Functional Assessment of Chronic Illness Therapy - Palliative Care, FACIT-Pal) up t0 4 weeks | Compare patient quality of life (FACIT-Pal) scores up to 4 weeks adjusting for baseline quality of life scores between the study arms. Score range 0-184 with higher scores indicating better quality of life. | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient FACIT-Pal Score longitudinally between study arms | Compare patient quality of life (FACIT-Pal) scores longitudinally between the study arms. Score range 0-184 with higher scores indicating better quality of life. | Up to 6 months |
| Patient Symptom Burden (revised Edmonton Symptom Assessment Scale, ESAS-r) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient End-of-Life (EOL) Care | Compare rate of receipt of intensive EOL care (renal replacement therapy, mechanical ventilation, and/or cardiopulmonary resuscitation or death in the intensive care unit) between study arms. | Within 30 days of patient death |
| Caregiver Quality of Life (PROMIS-29+2) |
Patient Inclusion Criteria:
Hospitalized patient with a diagnosis of advanced liver disease, defined as cirrhosis with one of the following (new or ongoing) within the prior six months from date of consent:
Ability to comprehend English
Patient Exclusion Criteria:
Caregiver Inclusion Criteria
Caregiver Exclusion Criteria
1. Inability to comprehend English
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grace Bizup, BA | Contact | 617-724-1316 | gbizup@mgh.harvard.edu | |
| William Munroe, BA | Contact | 617- 726-0161 | wlmunroe@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nneka Ufere, MD MSCE | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D058625 | End Stage Liver Disease |
| D005355 | Fibrosis |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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|
Compare patient symptom burden scores (ESAS-r) between the study arms. Score range 0-100 with higher scores indicating higher symptom burden. |
| Up to 6 months |
| Patient Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D) | Compare patient depression symptoms (HADS-D) between the study arms. Score range 0-21 with higher scores indicating higher depression symptoms. | Up to 6 months |
| Patient Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A) | Compare patient anxiety symptoms (HADS-A) between study arms. Score range 0-21 with higher scores indicating higher anxiety symptoms. | Up to 6 months |
| Patient End-of-Life (EOL) Care Communication with Clinicians | "Has [participant] talked with [participant's] doctor about the kind of medical care [participant] would want if [participant] were very sick or near the end of life?" | Final assessment prior to patient death or at 6 months |
| Documentation of Patient End-of-Life (EOL) Care Preferences | Compare documentation of EOL care preferences in the electronic health record between study arms since baseline. | After patient death, up to 60 months |
Compare caregiver quality of life (PROMIS-29+2) between study arms. Scores range 4-20 for raw items and 2-10 for cognitive function, with a higher score represents more of the concept being measured. Raw scores are translated into standardized T-scores. |
| Up to 6 months |
| Caregiver Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D) | Compare caregiver depression symptoms (HADS-D) between study arms. Score range 0-21 with higher scores indicating higher depression symptoms. | Up to 6 months |
| Caregiver Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A) between study arms. | Compare caregiver anxiety symptoms (HADS-A) between study arms. Score range 0-21 with higher scores indicating higher anxiety symptoms. | Up to 6 months |
| Caregiver Burden (Zarit Burden Index 12, ZBI-12) | Compare caregiver burden scores (ZBI-12) between study arms. Score range 0-48 with higher scores indicating higher caregiver burden. | Up to 6 months |
| Receipt of goal-concordant end-of-life care - patient wishes followed | Bereaved caregivers will be asked "In [participant's] opinion, to what extent were [the patient's] wishes followed in the medical care received in the last month of life?" Receipt of goal-concordant end-of-life care - patient wishes followed will be defined as care that "followed patients' wishes a great deal." | At least 1 month after patient death, up to 3 months |
| Quality of Life Near Death (QOD) | Bereaved caregivers will be asked "Just prior to the death of [the patient] (eg, his/her last week; when last seen), how would [participant] rate [the patient's] level of…" (1) "psychological distress?" (0 = none; 10 = extremely upset); (2) "physical distress?" (0 = none; 10 = extremely distressed); and (3) "overall quality of life in the last week of life/death?" (0 = worst possible; 10 = best possible). Ratings for these three items will be averaged (with reverse coding for the psychological and physical distress items). Scores range 0-10 with higher composite scores representing better QOD. | After patient death, up to 60 months |
| Prolonged Grief Disorder (PG-13-R) | Compare rates of prolonged grief disorder (PG-13-R) among bereaved caregivers between study arms. Score range 10-50 for symptom items with higher scores indicating worsening symptoms. | At least 12 months after patient death, up to 60 months |
| Healthcare Utilization at End-of-Life - Hospice | Compare rates of hospice utilization (yes/no) between study arms. | After patient death, up to 60 months |
| Healthcare Utilization at End-of-Life - Hospice length of stay | Compare number of days in hospice for patients admitted to hospice between study arms. | After patient death, up to 60 months |
| Healthcare Utilization - Days alive and out of the hospital | Compare days alive and out of the hospital at 6 months (180 days) after randomization | Up to 6 months |
| Healthcare Utilization - liver transplantation | Compare rates of liver transplantation (yes/no) between study arms | Up to 60 months |
| Patient Coping (Brief COPE) | Compare patient coping using the Brief Cope questionnaire between study arms. We will administer 14 items of the Brief COPE comprising seven subscales (active coping, use of emotional support, positive reframing, acceptance, behavioral disengagement, denial, and self-blame). Higher scores on each subscale indicate more use of that particular coping strategy. | Up to 6 months |
| Caregiver Coping (Brief COPE) | Compare caregiver coping using the Brief Cope questionnaire between study arms. We will administer 14 items of the Brief COPE comprising seven subscales (active coping, use of emotional support, positive reframing, acceptance, behavioral disengagement, denial, and self-blame). Higher scores on each subscale indicate more use of that particular coping strategy. | Up to 6 months |
| Patient Feeling Heard and Understood Scale | We will use the validated 4-item scale "Feeling Heard and Understood" as a self-reported measure capturing seriously ill patients' global assessment of their health care quality in the hospital environment. Response options range from 0 (not at all true) to 4 (completely true) for a score range of 0-16. | Up to 6 months |
| Caregiver Feeling Heard and Understood Scale | We will use the validated 4-item scale "Feeling Heard and Understood" as a self-reported measure capturing seriously ill patients' caregivers' global assessment of their loved one's health care quality in the hospital environment. Response options range from 0 (not at all true) to 4 (completely true) for a score range of 0-16. | Up to 6 months |
| Patient End-of-Life (EOL) Care Communication with Caregivers | "Has [participant] talked with [participant's] family or friends about the kind of medical care [participant] would want if [participant] were very sick or near the end of life?" | Final assessment prior to patient death or at 6 months |
| Patient Quality of Life (PROMIS-29+2) | Compare patient quality of life (PROMIS-29+2) scores between study arms. Scores range 4-20 for raw items and 2-10 for cognitive function, with a higher score represents more of the concept being measured. Raw scores are translated into standardized T-scores. | Up to 6 months |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |