HepHospital: A Pilot Trial of a Hepatology Home Hospital Intervention for Patients With Advanced Liver Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
This research study is evaluating a program that entails a healthcare at home intervention for people with advanced liver disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients ≥ 18 years old with diagnosis of cirrhosis based on histology, radiology, and/or elastography presenting to the emergency department or inpatient general medicine service
Ascites (requiring diuretics or serial large volume paracenteses)
Hepatic hydrothorax (requiring diuretics)
Hepatic encephalopathy (requiring medications)
Disqualifiers
History of solid organ transplantation
On hemodialysis
MELD score > 20
Score <10 on Simplified Animal Naming Test (S-ANT1)
Trial design
Design model
Single group
Treatments tested in this trial
Hepatology Home Hospital
BehavioralThe 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Hepatology Hospital at HomeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Escalation Rate
The intervention will be deemed feasible if less than 20% of enrolled patients have escalation of care back to the inpatient (brick-and-mortar) hospital
Time frame
18 monthsSecondary outcomes
1
Patient Experience
To assess patient experience scores (Picker Patient Experience Questionnaire, Global satisfaction questionnaire) at discharge from HepHospital
Time frame
Up to 90 days2
Adverse Event Reporting
We will assess rates of adverse events (acute kidney injury, falls, delirium, deep vein thrombosis/pulmonary embolism, escalation of care back to an inpatient hospital setting for at least 1 overnight stay, and death) for patient enrolled in HepHospital
Time frame
Up to 90 days3
Acceptability
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.
Time frame
18 monthsOther outcomes
1
Decline Rate
We will assess rates that patients decline to enroll in HepHospital
Time frame
18 months2
Quality of life (PROMIS-29 +2)
Change in participants' QOL as measured by the PROMIS-29+2 scale throughout the study.
Time frame
Baseline to post-discharge (+5 business day window) and 30-days (+10 business day window) post-discharge3
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.
Time frame
Baseline to post-discharge (+5 business day window) and 30-days (+10 business day window) post-discharge4
Unplanned readmission(s) after index hospitalization
We will assess # of unplanned readmission(s) at 30- and 90-days post-discharge
Time frame
Day of discharge to 30-days and 90-days post-dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov