Cirrhosis Medical Home
(CMH Trial)

Recruiting in Palo Alto (17 mi)

Overseen byEric Orman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Indiana University

Trial Summary

What is the purpose of this trial?

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

Able to be consented, either in person or through legally authorized representative

Access to a telephone

Decompensated cirrhosis as denoted by either: active ascites requiring paracentesis during hospitalization or active overt hepatic encephalopathy requiring lactulose during hospitalization

See 4 more

Exclusion Criteria

You have received a transplant of any organ.

You are planning to have a liver transplant in the next 6 months.

You have difficulty thinking or remembering things.

See 7 more

Treatment Details

Interventions

Care Coordinator Intervention for Direct Intervention Group (Behavioural Intervention)
Care Coordinator Intervention for Standard of Care Group (Behavioural Intervention)
Caregiver Intervention (Behavioural Intervention)

Participant Groups

3Treatment groups

Active Control

Placebo Group

Group I: Direct InterventionActive Control1 Intervention

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.

Group II: Standard of CarePlacebo Group1 Intervention

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.

Group III: CaregiverPlacebo Group1 Intervention

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