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Palliative Care for Non-Malignant Diseases (COMPASS Trial) (COMPASS)

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ClinicalTrials.gov Identifier: NCT03022630
Recruitment Status : Terminated (slow enrollment)
First Posted : January 16, 2017
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Gordon Bernard, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Liver Diseases Liver Cirrhosis NASH (Non-Alcoholic Steatohepatitis) Other: Comprehensive Palliative Care services Other: Usual hepatic care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : February 6, 2017
Actual Primary Completion Date : June 21, 2018
Actual Study Completion Date : June 21, 2018


Arm Intervention/treatment
Comprehensive Palliative Care services
Comprehensive Palliative Care services in addition to usual hepatic care
Other: 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.

Usual hepatic care
Usual hepatic care
Other: 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.




Primary Outcome Measures :
  1. Time to first hospital readmission within 1-year post randomization [ Time Frame: 1 year post-randomization ]
    Assess the impact of palliative care services on time to first hospital readmission


Secondary Outcome Measures :
  1. Days alive out of hospital [ Time Frame: 6 months post-randomization ]
    Days alive out of hospital from randomization to 6 months post randomization compared across arms

  2. Total days in hospital [ Time Frame: 1 year post-randomization ]
    Total days in hospital from randomization to 1 year post randomization compared across arms

  3. Total days in ICU [ Time Frame: 1 year post-randomization ]
    Total days in ICU from randomization to 1 year post randomization compared across arms

  4. Number of hospital readmissions [ Time Frame: 1 year post-randomization ]
    Number of hospital readmissions from randomization to 1 year post randomization compared across arms

  5. Median length of hospital stay per admission [ Time Frame: 1 year post-randomization ]
    Median length of hospital stay per admission from randomization to 1 year post randomization compared across arms

  6. Hospice Referral [ Time Frame: 1 year post-randomization ]
    Number of transfers to hospice within 1 year post randomization compared across arms

  7. Time to Hospice Placement [ Time Frame: 1 year post-randomization ]
    Number of days from hospice referral to time to hospice placement

  8. Chronic Liver Disease Questionnaire (CLDQ) [ Time Frame: Change from baseline over 1 year post-randomization ]
    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.

  9. EQ-5D-5L [ Time Frame: Change from baseline over 1 year post-randomization ]
    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.

  10. PROMIS Emotional Distress - Anxiety - Short Form 4a [ Time Frame: Change from baseline over 1 year post-randomization ]
    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.

  11. PROMIS Emotional Distress - Depression - Short Form 4a [ Time Frame: Change from baseline over 1 year post-randomization ]
    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.

  12. Satisfaction with Care (Quality of End-of-Life Care: Questionnaire for Patient) [ Time Frame: Change from baseline over 1 year post-randomization ]
    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 quality of care.

  13. Kingston Caregiver Stress Scale [ Time Frame: Change from baseline over 1 year post-randomization ]
    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.

  14. Satisfaction with Care (Quality of End-of-Life Care: Questionnaire for Patient adapted for Caregiver) [ Time Frame: Change from baseline over 1 year post-randomization ]
    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.

  15. Liver Transplant Status [ Time Frame: 1 year post-randomization ]
    Number of deferred, listed, and declined listing for liver transplant compared across arms

  16. MELD Score [ Time Frame: Change from baseline over 1 year post-randomization ]
    Change in MELD score compared across arms

  17. Completed Liver Transplants [ Time Frame: 1 year post-randomization ]
    Number of patients with completed liver transplants compared across arms

  18. Physical symptoms [ Time Frame: 1 year post-randomization ]
    Number of documented physical symptoms (ascites, variceal bleeding, encephalopathy, etc.) compared across arms

  19. Presence of Advance Directives [ Time Frame: 1 year post-randomization ]
    Percentage of patients with documented advance care directives compared across arms

  20. Survival [ Time Frame: 1 year post-randomization ]
    Survival rate compared across arms

  21. Provider Satisfaction [ Time Frame: Change from Baseline to 3 years post study-start (study closeout) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022630


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Gordon Bernard, MD Vanderbilt University

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Responsible Party: Gordon Bernard, Study Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03022630     History of Changes
Other Study ID Numbers: 160746
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gordon Bernard, Vanderbilt University Medical Center:
palliative care
cirrhosis
liver disease
hepatology
end of life care
supportive care

Additional relevant MeSH terms:
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Fibrosis
Liver Diseases
Liver Cirrhosis
Fatty Liver
Non-alcoholic Fatty Liver Disease
Pathologic Processes
Digestive System Diseases