Cirrhosis, LiverLiverPalNCT04953143
LiverPAL: A Pilot Study of Inpatient Palliative Care for Patients With Advanced Liver Disease
A study testing LiverPal Intervention in people with Cirrhosis, Liver, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Frequently patients with advanced liver disease experience physical and emotional symptoms during their hospitalization that can may cause a level of discomfort to both the patient and the family members that surround them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- LiverPal Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2022to 16 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Patient Inclusion Criteria:
- Adult (≥ 18 years old) with advanced liver disease defined as cirrhosis complicated by one of the following (new or ongoing) clinically-evidence decompensating events
- Ascites (requiring diuretics or large volume paracenteses)
- Hepatic encephalopathy (requiring medical therapy)
- History of variceal bleed episode within 1 year of enrollment
- Admitted to the general medicine service
- Ability fo communicate in English and provide informed consent
- Have a score ≥ 7 on the Short Portable Mental Status Questionnaire
Patient Exclusion Criteria:
- Patients with severe hepatic encephalopathy or any other comorbid condition which the primary medical team believes prohibits compliance with study procedures
- Patients with advanced malignancies being treated with palliative intent
- Patients already receiving specialty palliative care and/or hospice care
Caregiver Eligibility Criteria
- A relative or friend of eligible patient, who lives with them and has in-person contact with them at least twice per week
- Verbally fluent in English or able to complete questionnaires with the help of an interpreter
- Age 18 or older
Clinician Selection: All palliative care clinicians who deliver the LiverPal intervention will participate in qualitative interviews. Inpatient clinicians who provided direct care to enrolled patients in either the inpatient or outpatient setting will also be eligible to participate in the qualitative interviews.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Frequently patients with advanced liver disease experience physical and emotional symptoms during their hospitalization that can may cause a level of discomfort to both the patient and the family members that surround them.
This study involves the early introduction of a team of clinicians that specialize in the lessening (palliation) of many of these discomforting symptoms. This team of clinicians is called the palliative care team and they focus on ways to improve pain and other symptom management and to assist patients and their families in coping with the physical, emotional and social issues associated with a diagnosis of advanced liver disease. The team consists of physicians and advance practice nurses who have been specially trained in the care of patients facing serious illness and their caregivers.
The investigators are studying the feasibility of delivering this program, the acceptability and satisfaction with the program, and changes in the quality of life, illness understanding, and symptoms of hospitalized patients who receive the program and their caregivers. The study will use a series of questionnaires to measure the study participants' quality of life, physical symptoms, illness and prognostic understanding, and mood. Study questionnaires will be completed in the hospital, home or clinic. Qualitative interviews will be conducted with hepatology and palliative care clinicians as well as patients and caregivers.
- Conditions
- Cirrhosis, Liver
- Being tested
- LiverPal Intervention
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiverPal InterventionBehavioural
Inpatient longitudinal palliative care intervention
- Patients will complete baseline assessments and will be followed by the palliative care clinicians delivering the LiverPal intervention during each of their hospitalizations over a 3 month period
LiverPal intervention domains include the following:
- Therapeutic relationship
- Symptom management
- Coping with illness
- Prognostic awareness and illness understanding
- Treatment decision-making
- End-of-life care
| Study group | Role | What they receive |
|---|---|---|
| Pilot | Experimental | Inpatient longitudinal palliative care intervention that includes the following domains:
* Therapeutic relationship: Developing trust and credibility with patients and their families
* Symptom management: Proactive symptom management for common advanced liver disease symptoms including pain, fatigue, anorexia, breathlessness, depression and anxiety
* Coping with illness: Introduction of strategies to improve adjustment and meaning in life; bolstering caregiver coping
* Prognostic awareness and illness understanding: Assessing patients' level of prognostic awareness and discussing strategies to help patients cope with uncertainty
* Treatment decision-making: Supporting patients and caregivers in their medical decision-making and assessing their values in decision-making
* End-of-life care: Review/discuss selection of healthcare proxy, preferences for end-of-life care Receives: Behavioral: LiverPal Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
LiverPal intervention refinement
The investigators will conduct qualitative interviews with the patients and caregivers enrolled in the open pilot phase as well as LiverPal clinicians to elicit stakeholder feedback on the intervention. The qualitative component of the exit interviews will explore 1) patients', caregivers' and clinicians' perceptions of the acceptability and content of LiverPal; 2) any barriers or challenges to providing or receiving LiverPal; and 3) suggested modifications to LiverPal to improve its delivery in the inpatient setting
Measured: Time Frame: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start14 Jan 2022
- Primary completion16 Aug 2022
- Study completion16 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Association for the Study of Liver Diseases
- Responsible party
- Principal investigator, Nneka nnaoke Ufere, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953143
- Sponsor's protocol ID
- 2021P001402
- Acronym
- LiverPal
- Status last verified
- Jun 2023
- First submitted
- 28 Jun 2021
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LiverPAL: A Pilot Study of Inpatient Palliative Care for Patients With Advanced Liver Disease
- ClinicalTrials.gov ID
- NCT04953143
- Acronym / sponsor ID
- LiverPal / 2021P001402
- Conditions
- Cirrhosis, Liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Association for the Study of Liver Diseases
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 16 Aug 2022 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Frequently patients with advanced liver disease experience physical and emotional symptoms during their hospitalization that can may cause a level of discomfort to both the patient and the family members that surround them.
This study involves the early introduction of a team of clinicians that specialize in the lessening (palliation) of many of these discomforting symptoms. This team of clinicians is called the palliative care team and they focus on ways to improve pain and other symptom management and to assist patients and their families in coping with the physical, emotional and social issues associated with a diagnosis of advanced liver disease. The team consists of physicians and advance practice nurses who have been specially trained in the care of patients facing serious illness and their caregivers.
The investigators are studying the feasibility of delivering this program, the acceptability and satisfaction with the program, and changes in the quality of life, illness understanding, and symptoms of hospitalized patients who receive the program and their caregivers. The study will use a series of questionnaires to measure the study participants' quality of life, physical symptoms, illness and prognostic understanding, and mood. Study questionnaires will be completed in the hospital, home or clinic. Qualitative interviews will be conducted with hepatology and palliative care clinicians as well as patients and caregivers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot | Experimental | Behavioral: LiverPal InterventionInpatient longitudinal palliative care intervention that includes the following domains: * Therapeutic relationship: Developing trust and credibility with patients and their families * Symptom management: Proactive symptom management for common advanced liver disease symptoms including pain, fatigue, anorexia, breathlessness, depression and anxiety * Coping with illness: Introduction of strategies to improve adjustment and meaning in life; bolstering caregiver coping * Prognostic awareness and illness understanding: Assessing patients' level of prognostic awareness and discussing strategies to help patients cope with uncertainty * Treatment decision-making: Supporting patients and caregivers in their medical decision-making and assessing their values in decision-making * End-of-life care: Review/discuss selection of healthcare proxy, preferences for end-of-life care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiverPal InterventionInpatient longitudinal palliative care intervention - Patients will complete baseline assessments and will be followed by the palliative care clinicians delivering the LiverPal intervention during each of their hospitalizations over a 3 month period LiverPal intervention domains include the following: * Therapeutic relationship * Symptom management * Coping with illness * Prognostic awareness and illness understanding * Treatment decision-making * End-of-life care | Behavioural | Pilot |
Primary outcome
LiverPal intervention refinement
Time frame: Time Frame: Up to 1 year
The investigators will conduct qualitative interviews with the patients and caregivers enrolled in the open pilot phase as well as LiverPal clinicians to elicit stakeholder feedback on the intervention. The qualitative component of the exit interviews will explore 1) patients', caregivers' and clinicians' perceptions of the acceptability and content of LiverPal; 2) any barriers or challenges to providing or receiving LiverPal; and 3) suggested modifications to LiverPal to improve its delivery in the inpatient setting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Cirrhosis, Liver
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LiverPal Intervention in people with Cirrhosis, Liver, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LiverPal intervention refinement (time frame: Time Frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.