HepHospital: A Hepatology Home Hospital Intervention for Patients With Advanced Liver Disease

January 22, 2024 updated by: Nneka nnaoke Ufere, Massachusetts General Hospital

HepHospital: A Pilot Trial of a Hepatology Home Hospital Intervention for Patients With Advanced Liver Disease

This research study is evaluating a program that entails home-based care for people with advanced liver disease.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
        • Contact:
        • Contact:
          • Nneka Ufere, MD, MSCE
        • Principal Investigator:
          • Nneka Ufere, MD, MSCE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult patients ≥ 18 years old with a diagnosis of cirrhosis based on histology, radiology, and/or elastography
  2. Admitted for symptomatic ascites
  3. Receiving their outpatient hepatology and/or primary care at MGH
  4. Hemodynamically stable during the first 24 hours of hospital admission
  5. Must have telephone or internet/wifi access
  6. Residing within the designated geographic area for MGH Home Hospital Service

Exclusion Criteria:

  1. Have > grade 1 hepatic encephalopathy
  2. The presence of asterixis
  3. Have a current diagnosis of hepatic encephalopathy on medical therapy and do not have a caregiver at home
  4. Have uncontrolled neuropsychiatric or neurodegenerative illness prohibiting informed consent
  5. Are admitted to the intensive care unit
  6. Have refractory ascites or are on dialysis
  7. Current admission for acute portal vein thrombosis, GI bleeding, or alcohol-related hepatitis
  8. Have a history of solid organ transplantation of any organ
  9. Reside within a long-term care or rehabilitation facility
  10. Undomiciled
  11. In police custody
  12. Require more than the assistance of one person to reach a bedside commode
  13. Require routine administration of controlled substances
  14. Those deemed ineligible based on the MGH Home Hospital, inpatient medicine or hepatology clinician evaluation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hepatology Hospital at Home
Patients with cirrhosis presenting with symptomatic ascites receive their care in the home.
The Hepatology Home Hospital intervention entails the following: patient-reported symptoms and vital signs with appropriate triggers for phone calls and home visits, and regular communication with hepatology clinicians regarding care delivered at home to ensure continuity of care.
No Intervention: Usual Hepatology Care
Patients with cirrhosis presenting with symptomatic ascites receive their care in the hospital, as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment Rate
Time Frame: 1 year
The proposed intervention will be deemed feasible if ≥ 60% of eligible patients are enrolled in the study
1 year
Retention Rate
Time Frame: 1 year
The proposed intervention will be deemed feasible if at least 60% of enrolled patients complete the 7-day post-discharge patient-reported outcomes measures
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of the intervention
Time Frame: 1 year
Qualitative acceptability ratings from patients, caregivers, and clinicians obtained via exit individual interviews regarding acceptability (i.e. usefulness, effectiveness, and relevance of the intervention) from patients, family caregivers, and clinicians. The intervention will be deemed acceptable if ≥ 60% of patients, family caregivers, and clinicians report that the intervention was helpful.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unplanned readmission(s) after index hospitalization
Time Frame: Day of discharge to 30-days and 90-days post-discharge
We will assess # of unplanned readmission(s) at 30- and 90-days post-discharge
Day of discharge to 30-days and 90-days post-discharge
Emergency Department Visit(s) after index hospitalization
Time Frame: Day of discharge to 30-days and 90-days post-discharge
We will assess # of emergency department visit(s) at 30- and 90-days post-discharge
Day of discharge to 30-days and 90-days post-discharge
Transfer back to hospital
Time Frame: From date of admission to date of discharge, an expected average 7 days
We will assess whether patients were transferred back to the hospital after their admission to the home hospital program (yes or no)
From date of admission to date of discharge, an expected average 7 days
Time to first outpatient GI/hepatology appointment
Time Frame: Day of discharge to 90-days post-discharge
We will assess time (in days) to first outpatient GI/hepatology appointment within 90 days after discharge from the hepatology home hospital intervention
Day of discharge to 90-days post-discharge
Change in symptom Burden (Edmonton Symptom Assessment System-revised, ESAS-r)
Time Frame: Baseline to 7 days post-discharge and 30 days post-discharge
Change in participants' symptom burden as measured by the ESAS-r throughout the study.
Baseline to 7 days post-discharge and 30 days post-discharge
Ascites-specific health-related quality of life (Ascites Questionnaire, Ascites-Q)
Time Frame: Baseline to 7 days post-discharge and 30 days post-discharge
Change in participants' ascites HRQOL as measured by the Ascites-Q throughout the study.
Baseline to 7 days post-discharge and 30 days post-discharge
Quality of life (PROMIS-29 +2)
Time Frame: Baseline to 7 days post-discharge and 30 days post-discharge
Change in participants' QOL as measured by the PROMIS-29+2 scale throughout the study.
Baseline to 7 days post-discharge and 30 days post-discharge
Self-Efficacy for Managing Chronic Conditions: Managing Medications (PROMIS-SF Meds)
Time Frame: Baseline to 7 days post-discharge and 30 days post-discharge
Change in participants' self-efficacy as measured by the PROMIS-SF Meds throughout the study.
Baseline to 7 days post-discharge and 30 days post-discharge
Self-Efficacy for Managing Chronic Conditions: Managing Symptoms (PROMIS-SF Symptoms)
Time Frame: Baseline to 7 days post-discharge and 30 days post-discharge
Change in participants' self-efficacy as measured by the PROMIS-SF Symptoms throughout the study.
Baseline to 7 days post-discharge and 30 days post-discharge
Illness Understanding (Cirrhosis Knowledge Questionnaire, CKQ)
Time Frame: Baseline to 7 days post-discharge and 30 days post-discharge
Change in participants' illness understanding as measured by the CKQ throughout the study.
Baseline to 7 days post-discharge and 30 days post-discharge
Caregiver Burden (Zarit Burden Interview 12, ZBI-12)
Time Frame: Baseline to 7 days post-discharge and 30 days post-discharge
participants' caregiver burden as measured by the ZBI-12 throughout the study.
Baseline to 7 days post-discharge and 30 days post-discharge
Caregiver Self-Efficacy (Family Caregiver Activation in Transitions, FCAT; Caregiver Self-Efficacy Scale, CSES-8)
Time Frame: Baseline to 7 days post-discharge and 30 days post-discharge
caregivers' self-efficacy as measured by the FCAT and CSES-8 throughout the study.
Baseline to 7 days post-discharge and 30 days post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

December 28, 2021

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 25, 2022

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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