Advanced Cirrhosis, Cirrhosis, Cirrhosis, Liver, End Stage Liver DIsease, Liver Disease Chronic
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALLiverPAL
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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient Inclusion Criteria: 1. 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: * Ascites (requiring diuretics or serial large volume paracenteses) * Spontaneous bacterial peritonitis * Hepatic hydrothorax (requiring diuretics) * Variceal bleed (with one or more occurrences) * Overt hepatic encephalopathy (requiring medications) 2. Ability to comprehend English Patient
Exclusion criteria
1. Prior history of liver transplantation 2. Have uncontrolled hepatic encephalopathy, cognitive impairment, psychiatric disorder or other comorbid condition which the primary medical, hepatology, and/or transplant surgery teams believes prohibits the ability to provide informed consent 3. Current or recent (within 5 years of receiving curative cancer treatment) history of extrahepatic malignancy (excluding non-melanoma skin cancer) 4. Presence of hepatocellular carcinoma beyond Milan criteria 5. Are already receiving hospice care 6. Receive a score of \<10 on the Simplified Animal Naming Test Caregiver Inclusion Criteria 1. Adult caregiver (≥ 18 years of age) 2. A relative or friend identified by the patient upon whom the patient relies for help and who likely is to be present in-person during hospitalizations or clinic appointments, or willing to participate by phone 3. Ability to comprehend English and can complete questionnaires Caregiver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Quality of Life (Functional Assessment of Chronic Illness Therapy - Palliative Care, FACIT-Pal) up t0 4 weeks | Up to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Symptom Burden (revised Edmonton Symptom Assessment Scale, ESAS-r) | Up to 6 months | Compare patient symptom burden scores (ESAS-r) between the study arms. Score range 0-100 with higher scores indicating higher symptom burden. |
| Patient Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D) | Up to 6 months | Compare patient depression symptoms (HADS-D) between the study arms. Score range 0-21 with higher scores indicating higher depression symptoms. |
| Patient FACIT-Pal Score longitudinally between study arms | Up to 6 months | 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. |
| Patient End-of-Life (EOL) Care Communication with Clinicians | Final assessment prior to patient death or at 6 months | 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? |
| Documentation of Patient End-of-Life (EOL) Care Preferences | After patient death, up to 60 months | Compare documentation of EOL care preferences in the electronic health record between study arms since baseline. |
| Patient Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A) | Up to 6 months | Compare patient anxiety symptoms (HADS-A) between study arms. Score range 0-21 with higher scores indicating higher anxiety symptoms. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Prolonged Grief Disorder (PG-13-R) | At least 12 months after patient death, up to 60 months | 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. |
| Healthcare Utilization at End-of-Life - Hospice | After patient death, up to 60 months | Compare rates of hospice utilization (yes/no) between study arms. |
| Healthcare Utilization at End-of-Life - Hospice length of stay | After patient death, up to 60 months | Compare number of days in hospice for patients admitted to hospice between study arms. |
| Healthcare Utilization - Days alive and out of the hospital | Up to 6 months | Compare days alive and out of the hospital at 6 months (180 days) after randomization |
| Healthcare Utilization - liver transplantation | Up to 60 months | Compare rates of liver transplantation (yes/no) between study arms |
| Patient End-of-Life (EOL) Care | Within 30 days of patient death | 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. |
| Caregiver Coping (Brief COPE) | Up to 6 months | 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. |
| Patient Feeling Heard and Understood Scale | Up to 6 months | 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. |
| Caregiver Feeling Heard and Understood Scale | Up to 6 months | 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. |
| Patient End-of-Life (EOL) Care Communication with Caregivers | Final assessment prior to patient death or at 6 months | 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? |
| Patient Quality of Life (PROMIS-29+2) | Up to 6 months | 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. |
| Patient Coping (Brief COPE) | Up to 6 months | 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. |
| Caregiver Quality of Life (PROMIS-29+2) | Up to 6 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. |
| Caregiver Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D) | Up to 6 months | Compare caregiver depression symptoms (HADS-D) between study arms. Score range 0-21 with higher scores indicating higher depression symptoms. |
| Caregiver Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A) between study arms. | Up to 6 months | Compare caregiver anxiety symptoms (HADS-A) between study arms. Score range 0-21 with higher scores indicating higher anxiety symptoms. |
| Caregiver Burden (Zarit Burden Index 12, ZBI-12) | Up to 6 months | Compare caregiver burden scores (ZBI-12) between study arms. Score range 0-48 with higher scores indicating higher caregiver burden. |
| Receipt of goal-concordant end-of-life care - patient wishes followed | At least 1 month after patient death, up to 3 months | 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. |
| Quality of Life Near Death (QOD) | After patient death, up to 60 months | 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. |
Countries
United States
Contacts
Primary ContactGrace Bizup, BA
Backup ContactWilliam Munroe, BA
Outcome results
None listed