Cirrhosis Medical Home (CMH)

• ClinicalTrials.gov Identifier: NCT04581369
• Recruitment Status: Recruiting
• First Posted: October 9, 2020
• Last Update Posted: October 21, 2021
• Sponsor: Indiana University
• Information provided by (Responsible Party): Eric Orman, Indiana University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cirrhosis, Liver	Other: Care Coordinator Intervention for Direct Intervention Group; Other: Care Coordinator Intervention for Standard of Care Group; Other: Caregiver Intervention	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

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.

• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: One member of the study team will randomize the participants and all other study personnel will remain blinded.
• Primary Purpose: Health Services Research
• Official Title: Cirrhosis Medical Home
• Actual Study Start Date: September 17, 2020
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: December 31, 2025

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Other: 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.; Other Name: Direct Intervention Group
Sham Comparator: 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.	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.; Other Name: Standard of Care Group
Placebo Comparator: 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.	Other: Caregiver Intervention; Caregivers of the participants will be assessed for caregiver burden at 3 time points.

Outcome Measures

Primary Outcome Measures :

1. Enrollment rate [ Time Frame: 24 months ]
   The proportion of screened patients/caregivers eligible, approached and enrolled will be calculated. This is an internal assessment relating not to participants but to department specific metrics.
2. Number of participants who dropped out [ Time Frame: 24 months ]
   This is the proportion of enrolled participants (patients and caregivers) who drop out of the study before completion. This is an internal assessment relating not to participants but to department specific metrics.
3. Number of participants with complete data [ Time Frame: at end of study ]
   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.

Secondary Outcome Measures :

1. Health Related Quality of Life: Medical Outcome Study Short Form (SF-36) [ Time Frame: every 3 months for 6 months, at initial enrollment, 3 month, and 6 month visits ]
   Assessment from the patient only through data collection from the Medical Outcome Study Short Form (SF-36) instrument. This 36 item questionnaire has a minimum score of 36 with a maximum score of 180; a higher score generally correlates to poorer health.
2. Physical Performance [ Time Frame: every 3 months for 6 months, at initial enrollment, 3 month, and 6 month visits ]
   Assessment from the patient only through data collection from the Short Physical Performance Battery (SPPB) instrument.
3. Depression Symptoms [ Time Frame: every 3 months for 6 months, at initial enrollment, 3 month, and 6 month visits ]
   Assessment from patient only through data collection from the Patient Health Questionnaire-9 (PHQ-9) instrument. This 9 item instrument that assesses depression and has a minimum score of 0 and a maximum score of 27; a lower score generally indicates no or a lesser amount of depression/anxiety than a higher score.
4. Anxiety Symptoms [ Time Frame: every 3 months for 6 months, at initial enrollment, 3 month, and 6 month visits ]
   Assessment from patient only through data collection from the Generalized Anxiety Disorder Scale (GAD-7) instrument. This 7 item instrument that assess anxiety has a minimum score of 0 and a maximum score of 21, with a lower score indicating no or lesser anxiety than a higher score.
5. Cognitive assessment with 3D CAM (Confusion Assessment Method) [ Time Frame: every 3 months for 6 months, at initial enrollment, 3 month, and 6 month visits ]
   Assessment of overall levels of cognitive status, including hepatic encephalopathy
6. Cognitive assessment with PHES (The Psychometric Hepatic Encephalopathy Score) [ Time Frame: every 3 months for 6 months, at initial enrollment, 3 month, and 6 month visits ]
   Assessment of overall levels of cognitive status, including hepatic encephalopathy
7. Caregiver Burden [ Time Frame: every 3 months for 6 months, at initial enrollment, 3 month, and 6 month visits ]
   Assessment from caregivers only through data collection from the Zarit Burden Interview-12 (ZBI-12) instrument; a lower score is generally indicative of a lower amount caregiver fatigue or perception of burden; a higher score generally correlates to a greater level of caregiver fatigue/perceived burden.
8. Acute Health Care Utilization [ Time Frame: one year ]
   This is an assessment of patient use of health care resources, including hospitalizations and Emergency room visits. For the patient only, data will be gathered from the patient and medical record relating to the participant's emergency room visits and hospital admissions/inpatient stays during the course of their enrollment in the study.
9. CMH Interactions [ Time Frame: every 2 weeks for 6 month enrollment of participant ]
   During participation in this study, patients randomized to the Cirrhosis Medical Home Arm will meet with study staff, at least every 2 weeks for 6 months to assess overall health of the patient.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Elizabeth Peek, BSN, RN; 317-278-9303; peeke@iu.edu

Contact: Regina Weber, BS, RRT; 317-278-3584; reginaw@iu.edu

Locations

United States, Indiana

Indiana University Division of Gastroenterolgy and Hepatology; Recruiting

Indianapolis, Indiana, United States, 46202

Contact: Regina Weber, BS, RRT 317-278-3584 reginaw@iu.edu

Contact: Eric Orman, MD 317-278-1630 esorman@iu.edu

Principal Investigator: Eric Orman, MD

Sponsors and Collaborators

Indiana University

Investigators

• Principal Investigator: Eric Orman, MD; Indiana University

More Information

• Responsible Party: Eric Orman, Assistant Professor of Medicine, Indiana University
• ClinicalTrials.gov Identifier: NCT04581369
• Other Study ID Numbers: CMH 2003678667
• First Posted: October 9, 2020
• Last Update Posted: October 21, 2021
• Last Verified: October 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Liver Cirrhosis; Fibrosis; Pathologic Processes; Liver Diseases; Digestive System Diseases