Palliative Care for Non-Malignant Diseases (COMPASS Trial)

NCT03022630 | Terminated Results

• 1 other identifier: 160746
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Diseases; Liver Cirrhosis; NASH (Non-Alcoholic Steatohepatitis)

Keywords

palliative care; cirrhosis; liver disease; hepatology; end of life care; supportive care

Outcome Measures

Primary Outcomes (1)

• Time to First Hospital Readmission Within 6 Months Post-randomization

  Assess the impact of palliative care services on time to first hospital readmission. Time frame was changed from 1 year to 6 months due to early termination.

  6 months post-randomization

Secondary Outcomes (21)

• Days Alive Out of Hospital

  6 months post-randomization

• Total Days in Hospital

  6 months post-randomization

• Total Days in ICU

  6 months post-randomization

• Number of Hospital Readmissions

  6 months post-randomization

• Median Length of Hospital Stay Per Admission

  6 months post-randomization

Study Arms (2)

Comprehensive Palliative Care services

OTHER

Comprehensive Palliative Care services in addition to usual hepatic care

Other: Comprehensive Palliative Care services

Usual hepatic care

OTHER

Usual hepatic care

Other: Usual hepatic care

Interventions

Comprehensive Palliative Care services OTHER

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.

Comprehensive Palliative Care services

Usual hepatic care OTHER

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.

Usual hepatic care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?"

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Liver Diseases; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease; Fibrosis

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatty Liver

Results Point of Contact

• Title: Dr. Cheryl Gatto
• Organization: Vanderbilt University Medical Center

cheryl.l.gatto.1@vumc.org

6153432252

Study Officials

• Gordon Bernard, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: January 16, 2017
• Study Start: February 6, 2017
• Primary Completion: June 21, 2018
• Study Completion: June 21, 2018
• Last Updated: November 22, 2019
• Results First Posted: November 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)