Clinical trial NCT03022630: Palliative Care for Non-Malignant Diseases (COMPASS Trial)
Official title: The Creation of Models for Palliative Assessments to Support Severe Illness (COMPASS) Investigation: Testing Early and Ongoing Implementation of Palliative Care for Incurable Non-malignant Diseases
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Diseases
Liver Cirrhosis
NASH (Non-Alcoholic Steatohepatitis)
Keywords: palliative care
cirrhosis
liver disease
hepatology
end of life care
supportive care
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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:

* Adult patients admitted to Vanderbilt University Medical Center with cirrhotic advanced liver disease and poor prognosis will be randomized to receive either usual hepatic care or usual hepatic care with comprehensive palliative care services.
* Participants randomized to the intervention arm will receive patient-friendly informational materials, a comprehensive initial palliative care consultation, and follow-up consultations while inpatient. After discharge from hospital, follow-up consults will occur via telephone contact. Telephone contacts will occur on a flexible schedule based on needs and wishes of the participant at a minimum frequency of one contact per month.
* Participants will receive the palliative care intervention for at least 1 year after randomization to the intervention arm or until death.
* Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a meeting is requested by the patient, the family, or treating physician. These consultations include the same palliative care services as the intervention arm, excluding the telephone follow-up consultations.
* All participants will complete quality of life, mood, and satisfaction with care assessments at specified time points for 1 year after randomization or until death. Optional caregiver participation includes completion of satisfaction with care assessments.

Specific aims include:

1. Assess the impact of systematic, comprehensive palliative care services compared to usual hepatic care on time to first hospital readmission within 1-year post randomization.
2. Assess the impact of systematic, comprehensive palliative care services compared to usual hepatic care on other hospital utilization, including days alive out of hospital within 6- months post randomization, total days in hospital (and ICU) within 1-year post randomization, number and cost of hospital admissions within 1-year post randomization, median length of stay per admission, transfers and time to hospice placement, and survival within 1-year post randomization.
3. Assess the impact of systematic, comprehensive palliative care services compared to usual hepatic care on qualify of life.
4. Assess the impact of systematic, comprehensive palliative care services compared to usual hepatic care on patient/caregiver satisfaction.
5. Evaluate the fidelity of the palliative care intervention and assess the generalizability of implementing a large-scale Palliative Care program.

Eligibility criteria: Inclusion Criteria:

* Inpatient at Vanderbilt University Medical Center with advanced cirrhotic liver disease, whose treating hepatologist indicates a 'No' response to the question, "Would you be surprised if this patient died within 1 year?"

Exclusion Criteria:

* Age \< 18 years
* Receipt of liver transplant at the time of potential enrollment
* Inability to give written informed consent (patient or surrogate decision-maker)
* Inability to respond to questions in English
* Treating hepatologist denies permission to enroll
* Receiving hepatology care at non-Vanderbilt sites (to ensure appropriate follow-up)

Primary outcomes:
measure: Time to First Hospital Readmission Within 6 Months Post-randomization
timeFrame: 6 months post-randomization
Secondary outcomes:
measure: Days Alive Out of Hospital
timeFrame: 6 months post-randomization
measure: Total Days in Hospital
timeFrame: 6 months post-randomization
measure: Total Days in ICU
timeFrame: 6 months post-randomization
measure: Number of Hospital Readmissions
timeFrame: 6 months post-randomization
measure: Median Length of Hospital Stay Per Admission
timeFrame: 6 months post-randomization
measure: Hospice Referral
timeFrame: 6 months post-randomization
measure: Time to Hospice Placement
timeFrame: 6 months post-randomization
measure: Change in Chronic Liver Disease Questionnaire (CLDQ)
timeFrame: Change from baseline over 6 months post-randomization
measure: Change in EQ-5D-5L
timeFrame: Change from baseline over 6 months post-randomization
measure: Change in PROMIS Emotional Distress - Anxiety - Short Form 4a
timeFrame: Change from baseline over 6 months post-randomization
measure: Change in PROMIS Emotional Distress - Depression - Short Form 4a
timeFrame: Change from baseline over 6 months post-randomization
measure: Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient)
timeFrame: Change from baseline over 6 months post-randomization
measure: Change in Kingston Caregiver Stress Scale
timeFrame: Change from baseline over 6 months post-randomization
measure: Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient Adapted for Caregiver)
timeFrame: Change from baseline over 6 months post-randomization
measure: Liver Transplant Status
timeFrame: 6 months post-randomization
measure: Model for End-Stage Liver Disease (MELD) Score
timeFrame: Baseline
measure: Completed Liver Transplants
timeFrame: 6 months post-randomization
measure: Physical Symptoms
timeFrame: 6 months post-randomization
measure: Presence of Advance Directives
timeFrame: 6 months post-randomization
measure: Survival
timeFrame: 6 months post-randomization
measure: Provider Satisfaction
timeFrame: Change from Baseline to study closeout.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Gordon Bernard, MD
role: PRINCIPAL_INVESTIGATOR
References: