Clinical trial NCT06396897: Hospital @ Home Model of Care for Cirrhosis
Official title: The Hospital @ Home Model of Care: A Novel Healthcare Solution for the Management of Decompensated Cirrhosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Decompensated Cirrhosis
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants enrolled into program
timeFrame: 2 years
Secondary outcomes:
measure: Number of participants with follow-up visits during program
timeFrame: 2 years
measure: Number of participants with follow-up visit 90 days after program
timeFrame: 2 years
measure: Number of participants with repeat ED visits
timeFrame: Days 7, 30, and 90
measure: Number of participants with rehospitalization
timeFrame: Days 7, 30, and 90
measure: Rate of Mortality
timeFrame: Days 7, 30, and 90
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU School of Medicine
state: Indiana
Study officials:
References: