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

Primary Purpose

Cirrhosis, End Stage Liver DIsease, Liver Cirrhosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hepatology Home Hospital
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hepatology Hospital at Home

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Acceptability of the intervention
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.

Full Information

First Posted
December 28, 2021
Last Updated
October 17, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05205954
Brief Title
HepHospital: A Hepatology Home Hospital Intervention for Patients With Advanced Liver Disease
Official Title
HepHospital: A Pilot Trial of a Hepatology Home Hospital Intervention for Patients With Advanced Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, End Stage Liver DIsease, Liver Cirrhosis, Liver Disease Chronic

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hepatology Hospital at Home
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Hepatology Home Hospital
Intervention Description
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.
Primary Outcome Measure Information:
Title
Enrollment Rate
Description
The proposed intervention will be deemed feasible if ≥ 60% of eligible patients are enrolled in the study
Time Frame
1 year
Title
Retention Rate
Description
The proposed intervention will be deemed feasible if at least 60% of enrolled patients complete the 7-day post-discharge patient-reported outcomes measures
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Acceptability of the intervention
Description
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.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Change in symptom Burden (Edmonton Symptom Assessment System-revised, ESAS-r)
Description
Change in participants' symptom burden as measured by the ESAS-r throughout the study.
Time Frame
Baseline to 7 days post-discharge
Title
Ascites-specific health-related quality of life (Ascites Questionnaire, Ascites-Q)
Description
Change in participants' ascites HRQOL as measured by the Ascites-Q throughout the study.
Time Frame
Baseline to 7 days post-discharge
Title
Quality of life (EuroQol 5D-5L)
Description
Change in participants' QOL as measured by the EQ-5D-5L throughout the study.
Time Frame
Baseline to 7 days post-discharge
Title
Self-Efficacy for Managing Chronic Conditions: Managing Medications (PROMIS-SF Meds)
Description
Change in participants' self-efficacy as measured by the PROMIS-SF Meds throughout the study.
Time Frame
Baseline to 7 days post-discharge
Title
Self-Efficacy for Managing Chronic Conditions: Managing Symptoms (PROMIS-SF Symptoms)
Description
Change in participants' self-efficacy as measured by the PROMIS-SF Symptoms throughout the study.
Time Frame
Baseline to 7 days post-discharge
Title
Illness Understanding (Cirrhosis Knowledge Questionnaire, CKQ)
Description
Change in participants' illness understanding as measured by the CKQ throughout the study.
Time Frame
Baseline to 7 days post-discharge
Title
Mood (Patient Health Questionnaire-4, PHQ-4)
Description
Change in participants' mood as measured by the PHQ-4 throughout the study.
Time Frame
Baseline to 7 days post-discharge
Title
Caregiver Burden (Zarit Burden Interview 12, ZBI-12)
Description
participants' caregiver burden as measured by the ZBI-12 throughout the study.
Time Frame
Baseline to 7 days post-discharge
Title
Caregiver Self-Efficacy (Family Caregiver Activation in Transitions, FCAT; Caregiver Self-Efficacy Scale, CSES-8)
Description
caregivers' self-efficacy as measured by the FCAT and CSES-8 throughout the study.
Time Frame
Baseline to 7 days post-discharge
Title
Unplanned readmission(s) after index hospitalization
Description
We will assess # of unplanned readmission(s) at 30- and 90-days post-discharge
Time Frame
Day of discharge to 30-days and 90-days post-discharge
Title
Emergency Department Visit(s) after index hospitalization
Description
We will assess # of emergency department visit(s) at 30- and 90-days post-discharge
Time Frame
Day of discharge to 30-days and 90-days post-discharge
Title
Transfer back to hospital
Description
We will assess whether patients were transferred back to the hospital after their admission to the home hospital program (yes or no)
Time Frame
From date of admission to date of discharge, an expected average 7 days
Title
Time to first outpatient GI/hepatology appointment
Description
We will assess time (in days) to first outpatient GI/hepatology appointment within 90 days after discharge from the hepatology home hospital intervention
Time Frame
Day of discharge to 90-days post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients ≥ 18 years old with a diagnosis of cirrhosis based on histology, radiology, and/or elastography Admitted for symptomatic ascites Receiving their outpatient hepatology and/or primary care at MGH Hemodynamically stable during the first 24 hours of hospital admission Must have telephone or internet/wifi access Residing within the designated geographic area for MGH Home Hospital Service Exclusion Criteria: Have > grade 1 hepatic encephalopathy The presence of asterixis Have a current diagnosis of hepatic encephalopathy on medical therapy and do not have a caregiver at home Have uncontrolled neuropsychiatric or neurodegenerative illness prohibiting informed consent Are admitted to the intensive care unit Have refractory ascites or are on dialysis Current admission for acute portal vein thrombosis, GI bleeding, or alcohol-related hepatitis Have a history of solid organ transplantation of any organ Reside within a long-term care or rehabilitation facility Undomiciled In police custody Require more than the assistance of one person to reach a bedside commode Require routine administration of controlled substances Those deemed ineligible based on the MGH Home Hospital, inpatient medicine or hepatology clinician evaluation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nneka Ufere, MD, MSCE
Phone
617-643-3408
Email
nufere@partners.org
First Name & Middle Initial & Last Name or Official Title & Degree
Enya Zhu
Email
ezhu3@mgh.harvard.edu
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nneka Ufere, MD, MSCE
First Name & Middle Initial & Last Name & Degree
Enya Zhu
Email
ezhu3@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Nneka Ufere, MD, MSCE

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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