Hospital @ Home Model of Care for Cirrhosis

NCT06396897 | Recruiting

• 1 other identifier: 21905
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Number of participants enrolled into program

  2 years

Secondary Outcomes (5)

• Number of participants with follow-up visits during program

  2 years

• Number of participants with follow-up visit 90 days after program

  2 years

• Number of participants with repeat ED visits

  Days 7, 30, and 90

• Number of participants with rehospitalization

  Days 7, 30, and 90

• Rate of Mortality

  Days 7, 30, and 90

Study Arms (1)

Decompensated Cirrhotics

OTHER

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

Interventions

Indiana University Health Hospital at Home Program OTHER

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.

Decompensated Cirrhotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

IU School of Medicine

Indianapolis, Indiana, 46202, United States

RECRUITING

Central Study Contacts

Regia Weber

CONTACT

317-278-3584; reginaw@iu.edu

Archita Desai, MD

CONTACT

(317) 278-1664; desaiar@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: We will perform a pilot study to establish the feasibility of enrollment, data collection, and outcome assessment for a future efficacy trial. Patients meeting pre-defined criteria will be offered care through H@H program as part of clinical care. The research team will partner with the clinical team to co-enroll into the study. Before starting H@H, patients wills be asked to participate in an interview and report HRQOL. During H@H care, participants will be followed for return to ED or hospital. After discharge from H@H, participants will complete patient satisfaction surveys within 2 weeks of discharge and be followed for 90-days for HCU and HRQOL. Caregivers will also be enrolled and surveyed on their experience. Furthermore, all participants and caregivers will be approached to complete an interview component to identify new opportunities and co-design a more refined H@H program, which we will call H@H 2.0.

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 2, 2024
• Study Start: May 10, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)