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Cirrhosis Medical Home (CMH)

Primary Purpose

Cirrhosis, Liver

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Care Coordinator Intervention for Direct Intervention Group

Care Coordinator Intervention for Standard of Care Group

Caregiver Intervention

About this trial

This is an interventional health services research trial for Cirrhosis, Liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Indiana University Division of Gastroenterolgy and Hepatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Placebo Comparator

Arm Label

Direct Intervention

Standard of Care

Caregiver

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

Enrollment rate

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.

Number of participants who dropped out

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.

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.

Secondary Outcome Measures

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

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.

Physical Performance

Assessment from the patient only through data collection from the Short Physical Performance Battery (SPPB) instrument.

Depression Symptoms

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.

Anxiety Symptoms

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.

Cognitive assessment with 3D CAM (Confusion Assessment Method)

Assessment of overall levels of cognitive status, including hepatic encephalopathy

Cognitive assessment with PHES (The Psychometric Hepatic Encephalopathy Score)

Assessment of overall levels of cognitive status, including hepatic encephalopathy

Caregiver Burden

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.

Acute Health Care Utilization

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.

CMH Interactions

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.

Full Information

NCT ID

NCT04581369

First Posted

September 22, 2020

Last Updated

July 20, 2023

Sponsor

Indiana University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04581369

Brief Title

Cirrhosis Medical Home

Acronym

CMH

Official Title

Cirrhosis Medical Home

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

September 17, 2020 (Actual)

Primary Completion Date

May 31, 2023 (Actual)

Study Completion Date

May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cirrhosis, Liver

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigator

Masking Description

One member of the study team will randomize the participants and all other study personnel will remain blinded.

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Direct Intervention

Arm Type

Active Comparator

Arm Description

Arm Title

Standard of Care

Arm Type

Sham Comparator

Arm Description

Arm Title

Caregiver

Arm Type

Placebo Comparator

Arm 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.

Intervention Type

Other

Intervention Name(s)

Care Coordinator Intervention for Direct Intervention Group

Other Intervention Name(s)

Direct Intervention Group

Intervention Description

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

Intervention Name(s)

Care Coordinator Intervention for Standard of Care Group

Other Intervention Name(s)

Standard of Care Group

Intervention Description

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

Intervention Name(s)

Caregiver Intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Enrollment rate

Description

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.

Time Frame

24 months

Title

Number of participants who dropped out

Description

Time Frame

24 months

Title

Number of participants with complete data

Description

Time Frame

at end of study

Secondary Outcome Measure Information:

Title

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

Description

Time Frame