Cirrhosis Medical Home

NCT04581369 | Completed Results

• 2 other identifiers: CMH 2003678667R03DK122230
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis, Liver

Outcome Measures

Primary Outcomes (3)

• Enrollment Rate

  The proportion of screened patients eligible, approached and enrolled will be calculated. This is an internal assessment relating not to participants but to department specific metrics.

  Time of Enrollment

• Number of Participants Who Dropped Out or Are Lost to Follow-up

  This is the proportion of enrolled participants (patients) who drop out of the study before completion. This is an internal assessment relating not to participants but to department specific metrics.

  At drop out date or lost to follow-up date, which every comes first an average of 6 months

• Number of Participants With Complete Data

  Completeness of the data collection for enrolled subjects and reasons for incomplete data will be recorded. This is an internal assessment relating not to participants but to department specific metrics.

  Through study completion, an average of 6 months

Secondary Outcomes (20)

• Acute Health Care Utilization

  6 months

• Health Related Quality of Life: Medical Outcome Study Short Form (SF-36)

  measure was completed at enrollment by patients only

• Health Related Quality of Life: Medical Outcome Study Short Form (SF-36)

  measure was completed at 3 months by patients only

• Health Related Quality of Life: Medical Outcome Study Short Form (SF-36)

  measure was completed at 6 months by patients only

• Depression Symptoms

  measure was completed at initial enrollment by patients only

Study Arms (3)

Direct Intervention

ACTIVE COMPARATOR

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.

Other: Care Coordinator Intervention for Direct Intervention Group

Standard of Care

SHAM COMPARATOR

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.

Other: Care Coordinator Intervention for Standard of Care Group

Caregiver

PLACEBO COMPARATOR

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

Other: Caregiver Intervention

Interventions

Care Coordinator Intervention for Direct Intervention Group 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.

Also known as: Direct Intervention Group

Direct Intervention

Care Coordinator Intervention for Standard of Care Group 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.

Also known as: Standard of Care Group

Standard of Care

Caregiver Intervention OTHER

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

Caregiver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Indiana University Division of Gastroenterolgy and Hepatology

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Eric Orman
• Organization: Indiana University

esorman@iu.edu

317-278-1630

Study Officials

• Eric Orman, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: One member of the study team will randomize the participants and all other study personnel will remain blinded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 9, 2020
• Study Start: September 17, 2020
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: July 17, 2024
• Results First Posted: July 17, 2024

Record last verified: 2024-06

Locations

US (1)