N/A
N=44
Cirrhosis Medical Home
Cirrhosis, Liver
Bottom Line
View on ClinicalTrials.gov: NCT04581369 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Enrollment Rate — 20; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Care Coordinator Intervention for Direct Intervention Group (Other); Care Coordinator Intervention for Standard of Care Group (Other); Caregiver Intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enrollment Rate |
20; 20 | — |
| PRIMARY Number of Participants Who Dropped Out or Are Lost to Follow-up |
3; 7 | — |
| PRIMARY Number of Participants With Complete Data |
4; 4; 4 | — |
| SECONDARY Acute Health Care Utilization |
17; 18; 0 | — |
| SECONDARY Health Related Quality of Life: Medical Outcome Study Short Form (SF-36) |
102; 100 | — |
| SECONDARY Health Related Quality of Life: Medical Outcome Study Short Form (SF-36) |
102; 100 | — |
| SECONDARY Health Related Quality of Life: Medical Outcome Study Short Form (SF-36) |
102; 100 | — |
| SECONDARY Depression Symptoms |
12; 18 | — |
| SECONDARY Depression Symptoms |
12; 18 | — |
| SECONDARY Depression Symptoms |
12; 18 | — |
| SECONDARY Physical Performance |
— | — |
| SECONDARY Physical Performance |
— | — |
| SECONDARY Physical Performance |
— | — |
| SECONDARY Anxiety Symptoms |
16; 16 | — |
| SECONDARY Anxiety Symptoms |
16; 16 | — |
| SECONDARY Anxiety Symptoms |
16; 16 | — |
| SECONDARY Cognitive Assessment With 3D CAM (Confusion Assessment Method) |
— | — |
| SECONDARY Cognitive Assessment With 3D CAM (Confusion Assessment Method) |
— | — |
| SECONDARY Cognitive Assessment With 3D CAM (Confusion Assessment Method) |
— | — |
| SECONDARY Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) |
2; 1; 0; 1 | — |
| SECONDARY Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) |
2; 1; 0; 1 | — |
| SECONDARY Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) |
2; 1; 0; 1 | — |
| SECONDARY Caregiver Burden |
10 | — |
Summary
To address the health care system's lack of care coordination, the Institute of Medicine and Centers for Medicare and Medicaid Services recommend the development of collaborative care models (CCM) in a wide range of clinical settings. CCMs are intended to provide coordinated, personalized care pragmatically using care coordinators. CCMs have successfully improved care in multiple patient populations, ranging from frail older adults to depression. In contrast, for patients with cirrhosis, there is a paucity of data to support the benefit of CCM in this medically complex and vulnerable population. At Indiana University, researchers have over 20 years of experience in developing, testing, and implementing CCMs successfully for patients living with dementia or depression. Building on these successes, we have customized the CCM to best meet the unique and complex biopsychosocial needs of patients with cirrhosis: the Cirrhosis Medical Home.
Eligibility Criteria
Inclusion Criteria for patients:
- Age ≥18 years
- Cirrhosis based on:
- biopsy
- characteristic clinical, laboratory, and imaging findings
- Decompensated cirrhosis as denoted by either:
- active ascites requiring paracentesis during hospitalization or
- active overt hepatic encephalopathy requiring lactulose during hospitalization
- Poor quality of life as defined by:
- SF-36 Physical and/or Mental Component Summary scale <40 (1SD below the mean of healthy subjects)
- Discharged to home, skilled nursing facility, sub-acute rehabilitation care, or long-term acute care
- Able to be consented, either in person or through legally authorized representative
- Access to a telephone
Inclusion criteria for caregivers:
- Age ≥18 years
- Identified caregiver of patient
- Able to be consented, either in person or through legally authorized representative
- Access to a telephone
Exclusion Criteria for patients:
- Solid organ transplant of any organ
- Life expectancy of less than 6 months
- Anticipated liver transplant within 6 months
- History of dementing illnesses and other neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, or vascular dementia
- Unable to complete study questionnaire due to hearing loss
- Legally blind
- Pregnant or nursing
- Incarcerated
- Concurrent enrollment in a related interventional research study
Exclusion criteria for caregivers:
- Impaired cognitive function
- Unable to complete study questionnaire due to hearing loss
- Legally blind
- Incarcerated
Data sourced from ClinicalTrials.gov (NCT04581369). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.