HepHospital: A Hepatology Home Hospital Intervention for Patients With Advanced Liver Disease
Study Details
Study Description
Brief Summary
This research study is evaluating a program that entails home-based care for people with advanced liver disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hepatology Hospital at Home
|
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.
|
Outcome Measures
Primary Outcome Measures
- Enrollment Rate [1 year]
The proposed intervention will be deemed feasible if ≥ 60% of eligible patients are enrolled in the study
- 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
Secondary Outcome Measures
- 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.
Other Outcome Measures
- Change in symptom Burden (Edmonton Symptom Assessment System-revised, ESAS-r) [Baseline to 7 days post-discharge]
Change in participants' symptom burden as measured by the ESAS-r throughout the study.
- Ascites-specific health-related quality of life (Ascites Questionnaire, Ascites-Q) [Baseline to 7 days post-discharge]
Change in participants' ascites HRQOL as measured by the Ascites-Q throughout the study.
- Quality of life (EuroQol 5D-5L) [Baseline to 7 days post-discharge]
Change in participants' QOL as measured by the EQ-5D-5L throughout the study.
- Self-Efficacy for Managing Chronic Conditions: Managing Medications (PROMIS-SF Meds) [Baseline to 7 days post-discharge]
Change in participants' self-efficacy as measured by the PROMIS-SF Meds throughout the study.
- Self-Efficacy for Managing Chronic Conditions: Managing Symptoms (PROMIS-SF Symptoms) [Baseline to 7 days post-discharge]
Change in participants' self-efficacy as measured by the PROMIS-SF Symptoms throughout the study.
- Illness Understanding (Cirrhosis Knowledge Questionnaire, CKQ) [Baseline to 7 days post-discharge]
Change in participants' illness understanding as measured by the CKQ throughout the study.
- Mood (Patient Health Questionnaire-4, PHQ-4) [Baseline to 7 days post-discharge]
Change in participants' mood as measured by the PHQ-4 throughout the study.
- Caregiver Burden (Zarit Burden Interview 12, ZBI-12) [Baseline to 7 days post-discharge]
participants' caregiver burden as measured by the ZBI-12 throughout the study.
- Caregiver Self-Efficacy (Family Caregiver Activation in Transitions, FCAT; Caregiver Self-Efficacy Scale, CSES-8) [Baseline to 7 days post-discharge]
caregivers' self-efficacy as measured by the FCAT and CSES-8 throughout the study.
- Unplanned readmission(s) after index hospitalization [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
- Emergency Department Visit(s) after index hospitalization [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
- Transfer back to hospital [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)
- Time to first outpatient GI/hepatology appointment [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients ≥ 18 years old with a diagnosis of cirrhosis based on histology, radiology, and/or elastography
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Admitted for symptomatic ascites
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Receiving their outpatient hepatology and/or primary care at MGH
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Hemodynamically stable during the first 24 hours of hospital admission
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Must have telephone or internet/wifi access
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Residing within the designated geographic area for MGH Home Hospital Service
Exclusion Criteria:
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Have > grade 1 hepatic encephalopathy
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The presence of asterixis
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Have a current diagnosis of hepatic encephalopathy on medical therapy and do not have a caregiver at home
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Have uncontrolled neuropsychiatric or neurodegenerative illness prohibiting informed consent
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Are admitted to the intensive care unit
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Have refractory ascites or are on dialysis
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Current admission for acute portal vein thrombosis, GI bleeding, or alcohol-related hepatitis
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Have a history of solid organ transplantation of any organ
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Reside within a long-term care or rehabilitation facility
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Undomiciled
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In police custody
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Require more than the assistance of one person to reach a bedside commode
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Require routine administration of controlled substances
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Those deemed ineligible based on the MGH Home Hospital, inpatient medicine or hepatology clinician evaluation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021P002486