Cirrhosis Medical Home

NCT ID: NCT04581369

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-17
• Study Completion Date: 2023-05-31

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.

Conditions

Cirrhosis, Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Direct 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 Type: ACTIVE_COMPARATOR

Care Coordinator Intervention for Direct Intervention Group

Intervention Type: OTHER

The First Visit: The care coordinator will conduct a visit within 72 hours of hospital discharge to assess the patient's physical, cognitive, and psychological status, and will complete a needs assessment for both the patient and family caregiver. These measures will be used to guide the use of care protocols and development of the individualized care plan. The care plan will be developed with an emphasis on coordinating services with the patient's providers.

The Second Visit: During the second visit, the coordinator will review the individualized care plan with both the patient and the family caregiver and will make revisions to the plan based on assessment outcomes.

The 6-month Interaction Period: Approximately every 2 weeks, the coordinator will meet with the participant to revisit the care plan and to facilitate care.

At the end of 6 months, all patients will be transitioned to receive full care by their primary care and specialty physicians.

Standard of Care

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 Type: SHAM_COMPARATOR

Care Coordinator Intervention for Standard of Care Group

Intervention Type: OTHER

For participants randomized to this arm, a consultation with the care team will be arranged prior to hospital discharge. Outcome measures will be obtained by blinded research staff from all enrolled subjects at baseline, 3 months, and 6 months. This is the extent of interventions received for participants in this arm.

Caregiver

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

Group Type: PLACEBO_COMPARATOR

Caregiver Intervention

Intervention Type: OTHER

Caregivers of the participants will be assessed for caregiver burden at 3 time points.

Interventions

Care Coordinator Intervention for Direct Intervention Group

The First Visit: The care coordinator will conduct a visit within 72 hours of hospital discharge to assess the patient's physical, cognitive, and psychological status, and will complete a needs assessment for both the patient and family caregiver. These measures will be used to guide the use of care protocols and development of the individualized care plan. The care plan will be developed with an emphasis on coordinating services with the patient's providers.

The Second Visit: During the second visit, the coordinator will review the individualized care plan with both the patient and the family caregiver and will make revisions to the plan based on assessment outcomes.

The 6-month Interaction Period: Approximately every 2 weeks, the coordinator will meet with the participant to revisit the care plan and to facilitate care.

At the end of 6 months, all patients will be transitioned to receive full care by their primary care and specialty physicians.

Intervention Type: OTHER

Care Coordinator Intervention for Standard of Care Group

For participants randomized to this arm, a consultation with the care team will be arranged prior to hospital discharge. Outcome measures will be obtained by blinded research staff from all enrolled subjects at baseline, 3 months, and 6 months. This is the extent of interventions received for participants in this arm.

Intervention Type: OTHER

Caregiver Intervention

Caregivers of the participants will be assessed for caregiver burden at 3 time points.

Intervention Type: OTHER

Other Intervention Names

Direct Intervention Group; Standard of Care Group

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• Impaired cognitive function
• Unable to complete study questionnaire due to hearing loss
• Legally blind
• Incarcerated

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Eric Orman

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Orman, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University Division of Gastroenterolgy and Hepatology

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R03DK122230

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CMH 2003678667

Identifier Type: -

Identifier Source: org_study_id