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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06396897
Other study ID # 21905
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 10, 2024
Est. completion date December 31, 2027

Study information

Verified date June 2024
Source Indiana University
Contact Regia Weber
Phone 317-278-3584
Email reginaw@iu.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States IU School of Medicine Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants enrolled into program 2 years
Secondary Number of participants with follow-up visits during program 2 years
Secondary Number of participants with follow-up visit 90 days after program 2 years
Secondary Number of participants with repeat ED visits Days 7, 30, and 90
Secondary Number of participants with rehospitalization Days 7, 30, and 90
Secondary Rate of Mortality Days 7, 30, and 90
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