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

Not Applicable

Not yet recruiting

• Conditions: Cirrhosis; Liver Disease Chronic; End Stage Liver DIsease; Liver Cirrhosis
• Interventions: Behavioral: Hepatology Home Hospital

• Registration Number: NCT05205954
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-28
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-25
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-24
• Study Start: 2024-03-01
• Primary Completion: 2025-02-28
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hepatology Hospital at Home	Hepatology Home Hospital	Patients with cirrhosis presenting with symptomatic ascites receive their care in the home.

Primary Outcome Measures

Name	Time	Method
Retention Rate	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
Enrollment Rate	1 year	The proposed intervention will be deemed feasible if ≥ 60% of eligible patients are enrolled in the study

Secondary Outcome Measures

Name	Time	Method
Acceptability of the intervention	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States