- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT06396897
Modello Hospital @ Home di cura per la cirrosi (H@H)
Il modello di cura Hospital @ Home: una nuova soluzione sanitaria per la gestione della cirrosi scompensata
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Regia Weber
- Numero di telefono: 317-278-3584
- Email: reginaw@iu.edu
Backup dei contatti dello studio
- Nome: Archita Desai, MD
- Numero di telefono: (317) 278-1664
- Email: desaiar@iu.edu
Luoghi di studio
-
-
Indiana
-
Indianapolis, Indiana, Stati Uniti, 46202
- Reclutamento
- IU School of Medicine
-
Contatto:
- Miranda Stovall
- Numero di telefono: (317) 278-2401
- Email: mirstova@iu.edu
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: Decompensated Cirrhotics
Phase 1:
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:
|
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Number of participants enrolled into program
Lasso di tempo: Phase 1 Baseline
|
Phase 1 Baseline
|
|
Reason for enrollment failure
Lasso di tempo: Phase 1 Baseline
|
Phase 1 Baseline
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of participants with follow-up consultations during Phase 2
Lasso di tempo: During H@H program and up to and including 90 days after program completion
|
During H@H program and up to and including 90 days after program completion
|
|
|
Number of participants with services utilized in the home during Phase 2
Lasso di tempo: During H@H program and up to and including 90 days after program completion
|
During H@H program and up to and including 90 days after program completion
|
|
|
Number of participants with ED visits
Lasso di tempo: During H@H program and up to and including 90 days after program completion
|
ED visits, including repeat visits, will be tracked |
During H@H program and up to and including 90 days after program completion
|
|
Number of participants with rehospitalization
Lasso di tempo: During H@H program and up to and including 90 days after program completion
|
During H@H program and up to and including 90 days after program completion
|
|
|
Number of participants with a liver transplant
Lasso di tempo: 30 and 90 days after H@H program completion
|
30 and 90 days after H@H program completion
|
|
|
Number of participants with hospice enrollment
Lasso di tempo: 30 and 90 days after H@H program completion
|
30 and 90 days after H@H program completion
|
|
|
Rate of Mortality
Lasso di tempo: up to 90 days after H@H program completion
|
up to 90 days after H@H program completion
|
|
|
PSQ 18
Lasso di tempo: at 2 weeks after H@H program completion
|
Patient Satisfaction Questionnaire |
at 2 weeks after H@H program completion
|
|
Telemedicine Questionnaire
Lasso di tempo: at 2 weeks after H@H program completion
|
at 2 weeks after H@H program completion
|
|
|
ZBI-12
Lasso di tempo: at 2 weeks after H@H program completion
|
Zarit Burden Interview Questionnaire |
at 2 weeks after H@H program completion
|
|
Promis 29+2
Lasso di tempo: up to 90 days after H@H program completion
|
change in health related quality of life |
up to 90 days after H@H program completion
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 21905
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .