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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05205954
• Other study ID #: 2021P002486
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: January 2024
• Source: Massachusetts General Hospital
• Contact: Nneka Ufere, MD, MSCE
• Phone: 617-643-3408
• Email: nufere[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• End Stage Liver DIsease
• Fibrosis
• Liver Cirrhosis
• Liver Disease Chronic
• Liver Diseases

Intervention

Behavioral:
• Hepatology Home Hospital
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in symptom Burden (Edmonton Symptom Assessment System-revised, ESAS-r)	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
Other	Ascites-specific health-related quality of life (Ascites Questionnaire, Ascites-Q)	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
Other	Quality of life (PROMIS-29 +2)	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
Other	Self-Efficacy for Managing Chronic Conditions: Managing Medications (PROMIS-SF Meds)	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
Other	Self-Efficacy for Managing Chronic Conditions: Managing Symptoms (PROMIS-SF Symptoms)	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
Other	Illness Understanding (Cirrhosis Knowledge Questionnaire, CKQ)	Change in participants' illness understanding as measured by the CKQ throughout the study.	Baseline to 7 days post-discharge and 30 days post-discharge
Other	Caregiver Burden (Zarit Burden Interview 12, ZBI-12)	participants' caregiver burden as measured by the ZBI-12 throughout the study.	Baseline to 7 days post-discharge and 30 days post-discharge
Other	Caregiver Self-Efficacy (Family Caregiver Activation in Transitions, FCAT; Caregiver Self-Efficacy Scale, CSES-8)	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
Other	Unplanned readmission(s) after index hospitalization	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
Other	Emergency Department Visit(s) after index hospitalization	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
Other	Transfer back to hospital	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
Other	Time to first outpatient GI/hepatology appointment	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
Primary	Enrollment Rate	The proposed intervention will be deemed feasible if = 60% of eligible patients are enrolled in the study	1 year
Primary	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	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