Hospital @ Home Model of Care for Cirrhosis (H@H)

The Hospital @ Home Model of Care: A Novel Healthcare Solution for the Management of Decompensated Cirrhosis

The purpose of this study is to work with patients diagnosed with end-stage liver disease to understand their perspectives on the Health at Home (H@H) Program, including desired outcomes and expectations, perceived barriers, and drivers. H@H is an emerging model of home-based care, designed to extend traditional, inpatient hospital care which may address these needs. Through H@H, acute medical care services as well as ancillary care such as rehabilitation therapy can be delivered in the home. The study is divided into three phases: Phase 1 occurs while the participant is an inpatient. Phase 2 is when the actual H@H program takes place as part of the participant's clinical care. The study team will not be involved in the Phase 2 - H@H program as it will be conducted by the clinical staff. Phase 3, at which point the participant enters a rehabilitation phase to transition the patient to self-management, involves a research jam session with the participant and caregiver to assess the value of the program.

Study Overview

• Status: Recruiting
• Conditions: Decompensated Cirrhosis
• Intervention / Treatment: Other: Indiana University Health Hospital at Home Program

Detailed Description

Hospital at Home (H@H) as an emerging model of care is designed as an extension for traditional inpatient hospital care. Patients experiencing certain medical conditions normally requiring admission to an inpatient hospital can instead consent to receive acute care treatment in their homes. Prior studies have shown success of this model through demonstration of clinical and economic efficacy and feasibility, as well as greater satisfaction with care for patients, their family members and their providers. Since November 2020, Centers for Medicare and Medicaid Services has provided a waiver for H@H services. Similarly in 2020, Indiana University Health (IUH) introduced the Hospital at Home (H@H) Program for its beneficiaries to increase hospital capacity during the Public Health Emergency. Through this program, primary medical management services as well as ancillary services such as Occupational Therapy, Physical Therapy, and diagnostic testing can be delivered in the home. This model has been successful used at IUH to management patients with moderate COVID-19 infection, common infectious diseases, and decompensated heart failure.

In the realm of liver disease, acute decompensations of chronic liver disease often require hospitalizations for acute management. In certain clinical scenarios, while the initial 24-48 hour period may require the intensive management offered in an acute care hospital, the remaining hospital days represent less acute and/or intense needs such as continued administration of IV medications, monitoring for safe transition to oral medications and/or daily lab monitoring for period of time. We hypothesize that services through the IUH H@H program can offer equally safe and effective for these clinical scenarios while improving patient satisfaction, reducing care-giver burden, being cost-saving and improving access to acute care hospital services to other patients. We also hypothesize that completing the acute care management in the home setting will lead to more effective transition to chronic management as measured by subsequent 30-day readmissions and 30-day emergency room visits leading to reduced overall cost of health care. As a next step in expansion, the IUH H@H team is partnering with the PI and IUH Hepatology team to manage select patients with chronic liver disease (CLD). The overall goal of this proposal is to assess whether IUH's H@H program represents a novel care delivery model in cirrhosis that is safe, improves patient and caregiver experience as well as reduces HCU in the high-risk, CLD population.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Regia Weber; Phone Number: 317-278-3584; Email: reginaw@iu.edu
• Study Contact Backup: Name: Archita Desai, MD; Phone Number: (317) 278-1664; Email: desaiar@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • IU School of Medicine
      • Contact: Miranda Stovall; Phone Number: (317) 278-2401; Email: mirstova@iu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

Inpatients at IU Health University or Methodist Hospitals with chronic liver disease who meet a pre-defined set of clinical criteria.

Description

Inclusion Criteria:

• Enrolled into IUH's H@H program
• At least 18 years of age
• Chronic liver disease/cirrhosis based on characteristic clinical, laboratory, and imaging findings
• English speaking
• Able to provide consent
• Caregiver able to be present during the acute phase of care (first 48 hours post-hospital discharge)
• Able to perform activities of daily living independently
• Lives within IU Health Home service area

Exclusion Criteria:

• Unable to complete study questionnaires due to neurocognitive disease, legal blindness or hearing loss
• Transplant of organ other than liver
• Pregnant
• Incarcerated
• New hemodialysis
• Blood pressure < 90/60, Pulse > 120, O2 > 6L or >2L above baseline
• HIV+/CD4 count < 200
• Receiving hospice services
• Concurrent enrollment in a related research study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Decompensated Cirrhotics; Phase 1: two questionnaires to assess patient reported outcomes; an open-ended patient interview using a variety of patient-engagement methods to assess program expectations Phase 2: • completion of the Hospital at Home (H@H) program as part of clinical care. In brief, the Hospital at Home program (H@H) is an innovative care delivery method that aims to provide hospital-level care at home and facilitate the transition care from the hospital to the home. Phase 3: researchers engage virtually to discuss actual experience, outcomes, and challenges. These will be semi-structured interviews about their perspectives on the program, including desired outcomes and expectations and perceived barriers and drivers and will last about two hours.; complete four questionnaires relating to quality of life.

Other: Indiana University Health Hospital at Home Program; Structure of Care in IUH H@H Program: The IUH H@H program allows patients to be cared for at home using home remote monitoring devices, travel laboratory services and both in-person and virtual rounding by the health care team. The team includes registered nurses (RN), advanced practice provider (APP, nurse practitioner and physician assistants) and hospitalist physician. Care at home is divided into 4 consecutive phases after initial hospitalization: (1) evaluation/planning, (2) acute, (3) recovery, and (4) rehabilitation. All patients are sent home with a RPM tablet used to obtain vital signs, send messages between patient and RN, & perform video visits. The device is Bluetooth enabled and does not require WiFi or a phone line. All data obtained is automatically pulled into the electronic medical record. The RN uses a device which enables remote physical exams, i.e., obtain heart, lung and bowel sounds, pictures (wounds, lines, etc.) for review by APP/MD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants enrolled into program	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with repeat ED visits	Days 7, 30, and 90
Number of participants with rehospitalization	Days 7, 30, and 90
Number of participants with follow-up visits during program	2 years
Number of participants with follow-up visit 90 days after program	2 years
Rate of Mortality	Days 7, 30, and 90

Collaborators and Investigators

• Sponsor: Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 21905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No