Clinical trial NCT05205954: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cirrhosis
End Stage Liver DIsease
Liver Cirrhosis
Liver Disease Chronic
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility criteria: 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

Primary outcomes:
measure: Enrollment Rate
timeFrame: 1 year
measure: Retention Rate
timeFrame: 1 year
Secondary outcomes:
measure: Acceptability of the intervention
timeFrame: 1 year
Other outcomes:
measure: Change in symptom Burden (Edmonton Symptom Assessment System-revised, ESAS-r)
timeFrame: Baseline to 7 days post-discharge and 30 days post-discharge
measure: Ascites-specific health-related quality of life (Ascites Questionnaire, Ascites-Q)
timeFrame: Baseline to 7 days post-discharge and 30 days post-discharge
measure: Quality of life (PROMIS-29 +2)
timeFrame: Baseline to 7 days post-discharge and 30 days post-discharge
measure: Self-Efficacy for Managing Chronic Conditions: Managing Medications (PROMIS-SF Meds)
timeFrame: Baseline to 7 days post-discharge and 30 days post-discharge
measure: Self-Efficacy for Managing Chronic Conditions: Managing Symptoms (PROMIS-SF Symptoms)
timeFrame: Baseline to 7 days post-discharge and 30 days post-discharge
measure: Illness Understanding (Cirrhosis Knowledge Questionnaire, CKQ)
timeFrame: Baseline to 7 days post-discharge and 30 days post-discharge
measure: Caregiver Burden (Zarit Burden Interview 12, ZBI-12)
timeFrame: Baseline to 7 days post-discharge and 30 days post-discharge
measure: Caregiver Self-Efficacy (Family Caregiver Activation in Transitions, FCAT; Caregiver Self-Efficacy Scale, CSES-8)
timeFrame: Baseline to 7 days post-discharge and 30 days post-discharge
measure: Unplanned readmission(s) after index hospitalization
timeFrame: Day of discharge to 30-days and 90-days post-discharge
measure: Emergency Department Visit(s) after index hospitalization
timeFrame: Day of discharge to 30-days and 90-days post-discharge
measure: Transfer back to hospital
timeFrame: From date of admission to date of discharge, an expected average 7 days
measure: Time to first outpatient GI/hepatology appointment
timeFrame: Day of discharge to 90-days post-discharge
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: