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

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

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

Conditions
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Cirrhosis, End Stage Liver DIsease, Liver Cirrhosis, Liver Disease Chronic

Intervention / Treatment
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* Behavioral: Hepatology Home Hospital


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hepatology Hospital at Home<br> | Behavioral: Hepatology Home Hospital<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment Rate | The proposed intervention will be deemed feasible if ≥ 60% of eligible patients are enrolled in the study | 1 year | 
| 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year |