Cirrhosis Medical Home (CMH)

Indiana University

Status: Completed

Conditions: Cirrhosis, Liver

Treatments: Other: Caregiver Intervention; Other: Care Coordinator Intervention for Direct Intervention Group; Other: Care Coordinator Intervention for Standard of Care Group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04581369

R03DK122230 (U.S. NIH Grant/Contract)

CMH 2003678667

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 3 patient groups, including a placebo group

Direct Intervention

Active Comparator group

Description:

Initial Evaluation: Prior to discharge, the care coordinator will review the hospital discharge plan, obtain the approval of the patient's physicians to co-manage the patient's care, and schedule a visit with the patient at their place of discharge. Participants in this arm will receive direct interaction with a care coordinator to develop an individualized care plan. Frequent assessments, at least once every two weeks, will occur to continue to follow or to modify the care plan based on the needs of the patient. At the end of 6 months, all patients will be transitioned to receive full care by their primary care and specialty physicians and their participation in this study will be ended.

Treatment:

Other: Care Coordinator Intervention for Direct Intervention Group

Standard of Care

Sham Comparator group

Description:

Prior to hospital discharge, the care coordinator will identify the primary care and/or hepatology provider of patients in the usual care group and will ensure follow up appointments at the time of hospital discharge. The coordinator will compose and send a letter to the primary care and/or hepatology provider summarizing the patient's diagnosis, hospital course, discharge medications, and the plan of follow-up care. If the patient does not already have a primary care or hepatology provider, the coordinator will work with the patient to identify a new provider. Subjects in this group will receive no further intervention.

Treatment:

Other: Care Coordinator Intervention for Standard of Care Group

Caregiver

Placebo Comparator group

Description:

The caregivers of people with cirrhosis will be enrolled in the study. They will complete the assessments at baseline, 3 months and 6 months.

Treatment:

Other: Caregiver Intervention