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Completed

NCT Number: NCT04581369

Cirrhosis Medical Home

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Division of Gastroenterolgy and Hepatology

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Direct Intervention Group

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.

Other names: Standard of Care Group

Caregiver Intervention

Other

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

Primary outcomes

  1. Enrollment Rate

    Time frame: Time of Enrollment

    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.

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

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

    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.

  3. Number of Participants With Complete Data

    Time frame: Through study completion, an average of 6 months

    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 outcomes

  1. Acute Health Care Utilization

    Time frame: 6 months

    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.

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

    Time frame: measure was completed at enrollment by patients only

    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. This assessment was for patients only and not for caregivers.

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

    Time frame: measure was completed at 3 months by patients only

    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. This assessment was for patients only and not for caregivers.

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

    Time frame: measure was completed at 6 months by patients only

    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. This assessment was for patients only and not for caregivers.

  5. Depression Symptoms

    Time frame: measure was completed at initial enrollment by patients only

    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.

  6. Depression Symptoms

    Time frame: measure was completed at 3 months by patients only

    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.

  7. Depression Symptoms

    Time frame: measure was completed at 6 months by patients only

    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.

  8. Physical Performance

    Time frame: measure was completed at initial enrollment by patients only

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

  9. Physical Performance

    Time frame: measure was completed at 3 months by patients only

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

  10. Physical Performance

    Time frame: measure was completed at 6 months by patients only

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

  11. Anxiety Symptoms

    Time frame: measure was completed at initial enrollment by patients only

    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.

  12. Anxiety Symptoms

    Time frame: measure was completed at 3 months by patients only

    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.

  13. Anxiety Symptoms

    Time frame: measure was completed at 6 months by patients only

    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.

  14. Cognitive Assessment With 3D CAM (Confusion Assessment Method)

    Time frame: measure was completed at initial enrollment by patients only

    Assessment of overall levels of cognitive status, including hepatic encephalopathy

  15. Cognitive Assessment With 3D CAM (Confusion Assessment Method)

    Time frame: measure was completed at 3 months by patients only

    Assessment of overall levels of cognitive status, including hepatic encephalopathy

  16. Cognitive Assessment With 3D CAM (Confusion Assessment Method)

    Time frame: measure was completed at 6 months by patients only

    Assessment of overall levels of cognitive status, including hepatic encephalopathy

  17. Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score)

    Time frame: measure was completed at initial enrollment by patients only

    Assessment of overall levels of cognitive status, including hepatic encephalopathy. PHES range is -18 to +6. Normal is > -4 (better). <= -5 is abnormal (worse).

  18. Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score)

    Time frame: measure was completed at 3 month enrollment by patients only

    Assessment of overall levels of cognitive status, including hepatic encephalopathy. PHES range is -18 to +6. Normal is > -4 (better). <= -5 is abnormal (worse).

  19. Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score)

    Time frame: measure was completed at 6 month enrollment by patients only

    Assessment of overall levels of cognitive status, including hepatic encephalopathy. PHES range is -18 to +6. Normal is > -4 (better). <= -5 is abnormal (worse).

  20. Caregiver Burden

    Time frame: caregivers completed at initial enrollment--while the plan was to complete at 3 and 6 months, none of the participants with liver disease for whom these people cared were alive at the 3 and 6 month mark so the instruments were not completed

    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.

    0-10 no burden, 10-20 mild-moderate burden, >20 high burden. Minimum: 0 Maximum: 48

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

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

Registry information

Acronym: CMH

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 9, 2020
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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