Cirrhosis, LiverCMHNCT04581369
Cirrhosis Medical Home
A study testing Care Coordinator Intervention for Direct Intervention Group and Caregiver Intervention in people with Cirrhosis, Liver, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- Care Coordinator Intervention for Direct Intervention Group and Caregiver Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2020to 31 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Division of Gastroenterolgy and Hepatology
Indianapolis, Indiana, 46202
About this study
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.
Read the 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
- Being tested
- Care Coordinator Intervention for Direct Intervention Group, Care Coordinator Intervention for Standard of Care Group, Caregiver Intervention
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Coordinator Intervention for Direct Intervention GroupOther
Also called 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.
Care Coordinator Intervention for Standard of Care GroupOther
Also called 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.
Caregiver InterventionOther
Caregivers of the participants will be assessed for caregiver burden at 3 time points.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Caregiver Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 6 months
Secondary outcomes (20)
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.
Measured: 6 months
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. This assessment was for patients only and not for caregivers.
Measured: measure was completed at enrollment by patients only
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. This assessment was for patients only and not for caregivers.
Measured: measure was completed at 3 months by patients only
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. This assessment was for patients only and not for caregivers.
Measured: measure was completed at 6 months by patients only
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.
Measured: measure was completed at initial enrollment by patients only
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.
Measured: measure was completed at 3 months by patients only
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.
Measured: measure was completed at 6 months by patients only
Physical Performance
Assessment from the patient only through data collection from the Short Physical Performance Battery (SPPB) instrument.
Measured: measure was completed at initial enrollment by patients only
Physical Performance
Assessment from the patient only through data collection from the Short Physical Performance Battery (SPPB) instrument.
Measured: measure was completed at 3 months by patients only
Physical Performance
Assessment from the patient only through data collection from the Short Physical Performance Battery (SPPB) instrument.
Measured: measure was completed at 6 months by patients only
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.
Measured: measure was completed at initial enrollment by patients only
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.
Measured: measure was completed at 3 months by patients only
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.
Measured: measure was completed at 6 months by patients only
Cognitive Assessment With 3D CAM (Confusion Assessment Method)
Assessment of overall levels of cognitive status, including hepatic encephalopathy
Measured: measure was completed at initial enrollment by patients only
Cognitive Assessment With 3D CAM (Confusion Assessment Method)
Assessment of overall levels of cognitive status, including hepatic encephalopathy
Measured: measure was completed at 3 months by patients only
Cognitive Assessment With 3D CAM (Confusion Assessment Method)
Assessment of overall levels of cognitive status, including hepatic encephalopathy
Measured: measure was completed at 6 months by patients only
Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score)
Assessment of overall levels of cognitive status, including hepatic encephalopathy. PHES range is -18 to +6. Normal is > -4 (better). <= -5 is abnormal (worse).
Measured: measure was completed at initial enrollment by patients only
Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score)
Assessment of overall levels of cognitive status, including hepatic encephalopathy. PHES range is -18 to +6. Normal is > -4 (better). <= -5 is abnormal (worse).
Measured: measure was completed at 3 month enrollment by patients only
Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score)
Assessment of overall levels of cognitive status, including hepatic encephalopathy. PHES range is -18 to +6. Normal is > -4 (better). <= -5 is abnormal (worse).
Measured: measure was completed at 6 month enrollment by patients only
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.
0-10 no burden, 10-20 mild-moderate burden, >20 high burden. Minimum: 0 Maximum: 48
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start17 Sep 2020
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Orman, Indiana University
- Investigators
- Eric Orman, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581369
- Sponsor's protocol ID
- CMH 2003678667
- Other IDs
- R03DK122230
- Acronym
- CMH
- Status last verified
- Jun 2024
- First submitted
- 22 Sep 2020
- Last updated
- 17 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Orman ES, Desai AP, Kuchana SK, Campbell N, Fowler NR, McCarty J, Pike F, Mosesso K, Hotchkiss T, Chalasani NP, Boustani M. The Cirrhosis Medical Home: A Pilot Randomized Trial of a Collaborative Care Model for Patients With Decompensated Cirrhosis. Clin Transl Gastroenterol. 2026 May 1;17(5):e01013. doi: 10.14309/ctg.0000000000001013.
PubMed 41778640
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cirrhosis Medical Home
- ClinicalTrials.gov ID
- NCT04581369
- Acronym / sponsor ID
- CMH / CMH 2003678667
- Conditions
- Cirrhosis, Liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Posted 17 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Direct Intervention | Active comparator | Other: Care Coordinator Intervention for Direct Intervention GroupInitial 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. |
| Standard of Care | Sham comparator | Other: Care Coordinator Intervention for Standard of Care GroupPrior 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. |
| Caregiver | Placebo comparator | Other: Caregiver InterventionThe caregivers of people with cirrhosis will be enrolled in the study. They will complete the assessments at baseline, 3 months and 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥18 years
- Cirrhosis based on:
- Decompensated cirrhosis as denoted by either:
- Poor quality of life as defined by:
- Discharged to home, skilled nursing facility, sub-acute rehabilitation care, or long-term acute care
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care Coordinator Intervention for Direct Intervention GroupAlso: Direct Intervention GroupThe 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 | Direct Intervention |
| Care Coordinator Intervention for Standard of Care GroupAlso: Standard of Care GroupFor 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 | Standard of Care |
| Caregiver InterventionCaregivers of the participants will be assessed for caregiver burden at 3 time points. | Other | Caregiver |
Primary outcome
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.
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.
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.
20 secondary outcomes
Acute Health Care Utilization
Time frame: 6 months
Health Related Quality of Life: Medical Outcome Study Short Form (SF-36)
Time frame: measure was completed at enrollment by patients only
Health Related Quality of Life: Medical Outcome Study Short Form (SF-36)
Time frame: measure was completed at 3 months by patients only
Health Related Quality of Life: Medical Outcome Study Short Form (SF-36)
Time frame: measure was completed at 6 months by patients only
Depression Symptoms
Time frame: measure was completed at initial enrollment by patients only
Depression Symptoms
Time frame: measure was completed at 3 months by patients only
Depression Symptoms
Time frame: measure was completed at 6 months by patients only
Physical Performance
Time frame: measure was completed at initial enrollment by patients only
Physical Performance
Time frame: measure was completed at 3 months by patients only
Physical Performance
Time frame: measure was completed at 6 months by patients only
Anxiety Symptoms
Time frame: measure was completed at initial enrollment by patients only
Anxiety Symptoms
Time frame: measure was completed at 3 months by patients only
Anxiety Symptoms
Time frame: measure was completed at 6 months by patients only
Cognitive Assessment With 3D CAM (Confusion Assessment Method)
Time frame: measure was completed at initial enrollment by patients only
Cognitive Assessment With 3D CAM (Confusion Assessment Method)
Time frame: measure was completed at 3 months by patients only
Cognitive Assessment With 3D CAM (Confusion Assessment Method)
Time frame: measure was completed at 6 months by patients only
Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score)
Time frame: measure was completed at initial enrollment by patients only
Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score)
Time frame: measure was completed at 3 month enrollment by patients only
Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score)
Time frame: measure was completed at 6 month enrollment by patients only
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41778640Orman ES, Desai AP, Kuchana SK, Campbell N, Fowler NR, McCarty J, Pike F, Mosesso K, Hotchkiss T, Chalasani NP, Boustani M. The Cirrhosis Medical Home: A Pilot Randomized Trial of a Collaborative Care Model for Patients With Decompensated Cirrhosis. Clin Transl Gastroenterol. 2026 May 1;17(5):e01013. doi: 10.14309/ctg.0000000000001013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Orman, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Coordinator Intervention for Direct Intervention Group and Caregiver Intervention in people with Cirrhosis, Liver, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Rate (time frame: Time of Enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04581369, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.