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.
