Clinical trial NCT04581369: Cirrhosis Medical Home
Official title: Cirrhosis Medical Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis, Liver
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-10-09
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Block randomization will be utilized to ensure balancing of treatment groups throughout enrollment. 20 participants will be assigned to the direct home interventions group and 20 will be assigned to standard of care.

Caregivers (40) belong to a single arm of the study with no randomization. All receive the same study procedures.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: In the Cirrhosis Medical Home, a care coordinator, supported by an interdisciplinary clinical team, will deliver a personalized intervention guided by a set of innovative tools: (i) patient-centered care protocols, (ii) a mobile office, (iii) care coordination support software, and (iv) dynamic feedback measures.

The overall goal is to improve quality of life of patients discharged from the hospital with cirrhosis and to reduce acute health care utilization for patients with cirrhosis.

Additionally, up to 40 caregivers will be enrolled in the trial.

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

Primary outcomes:
measure: Enrollment Rate
timeFrame: Time of Enrollment
measure: Number of Participants Who Dropped Out or Are Lost to Follow-up
timeFrame: At drop out date or lost to follow-up date, which every comes first an average of 6 months
measure: Number of Participants With Complete Data
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Acute Health Care Utilization
timeFrame: 6 months
measure: Health Related Quality of Life: Medical Outcome Study Short Form (SF-36)
timeFrame: measure was completed at enrollment by patients only
measure: Health Related Quality of Life: Medical Outcome Study Short Form (SF-36)
timeFrame: measure was completed at 3 months by patients only
measure: Health Related Quality of Life: Medical Outcome Study Short Form (SF-36)
timeFrame: measure was completed at 6 months by patients only
measure: Depression Symptoms
timeFrame: measure was completed at initial enrollment by patients only
measure: Depression Symptoms
timeFrame: measure was completed at 3 months by patients only
measure: Depression Symptoms
timeFrame: measure was completed at 6 months by patients only
measure: Physical Performance
timeFrame: measure was completed at initial enrollment by patients only
measure: Physical Performance
timeFrame: measure was completed at 3 months by patients only
measure: Physical Performance
timeFrame: measure was completed at 6 months by patients only
measure: Anxiety Symptoms
timeFrame: measure was completed at initial enrollment by patients only
measure: Anxiety Symptoms
timeFrame: measure was completed at 3 months by patients only
measure: Anxiety Symptoms
timeFrame: measure was completed at 6 months by patients only
measure: Cognitive Assessment With 3D CAM (Confusion Assessment Method)
timeFrame: measure was completed at initial enrollment by patients only
measure: Cognitive Assessment With 3D CAM (Confusion Assessment Method)
timeFrame: measure was completed at 3 months by patients only
measure: Cognitive Assessment With 3D CAM (Confusion Assessment Method)
timeFrame: measure was completed at 6 months by patients only
measure: Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score)
timeFrame: measure was completed at initial enrollment by patients only
measure: Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score)
timeFrame: measure was completed at 3 month enrollment by patients only
measure: Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score)
timeFrame: measure was completed at 6 month enrollment by patients only
measure: Caregiver Burden
timeFrame: caregivers completed at initial enrollment--while the plan was to complete at 3 and 6 months, none of the participants with liver disease for whom these people cared were alive at the 3 and 6 month mark so the instruments were not completed
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Division of Gastroenterolgy and Hepatology
state: Indiana
Study officials:
affiliation: Indiana University
name: Eric Orman, MD
role: PRINCIPAL_INVESTIGATOR
References: