- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05205954
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
Status
Not yet recruiting
Intervention / Treatment
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
- Name: Nneka Ufere, MD, MSCE
- Phone Number: 617-643-3408
- Email: nufere@partners.org
Study Contact Backup
- Name: Enya Zhu
- Email: ezhu3@mgh.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
Contact:
- Enya Zhu
- Email: ezhu3@mgh.harvard.edu
-
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:
- 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
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021P002486
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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