Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396897
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-04-30
Brief Title:
Hospital Home Model of Care for Cirrhosis
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
The Hospital Home Model of Care A Novel Healthcare Solution for the Management of Decompensated Cirrhosis
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HH
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 HH Program including desired outcomes and expectations perceived barriers and drivers HH is an emerging model of home-based care designed to extend traditional inpatient hospital care which may address these needs Through HH 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 HH program takes place as part of the participants clinical care The study team will not be involved in the Phase 2 - HH 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 HH 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 HH services Similarly in 2020 Indiana University Health IUH introduced the Hospital at Home HH 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 andor intense needs such as continued administration of IV medications monitoring for safe transition to oral medications andor daily lab monitoring for period of time We hypothesize that services through the IUH HH 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 HH 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 IUHs HH 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
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 andor intense needs such as continued administration of IV medications monitoring for safe transition to oral medications andor daily lab monitoring for period of time We hypothesize that services through the IUH HH 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 HH 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 IUHs HH 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None