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| ID | Type | Description | Link |
|---|---|---|---|
| R03DK122230 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria for patients:
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
Able to be consented, either in person or through legally authorized representative
Access to a telephone
Inclusion criteria for caregivers:
Exclusion Criteria for patients:
Exclusion criteria for caregivers:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Orman, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Division of Gastroenterolgy and Hepatology | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41778640 | Derived | 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. |
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The protocol allowed for up to 40 caregivers to enroll in this trial. We enrolled 4 caregivers. The protocol called for 40 participants with liver disease to be enrolled and we enrolled 40. Total enrollment is 44.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 at the place of discharge. Participants receive direct interaction with a care coordinator to develop an individualized care plan. Frequent assessments 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 full care by their primary care and specialty physicians and their participation in this study will be ended. Care Coordinator Intervention for Direct Intervention Group: The coordinator will conduct a visit within 72 hours of discharge to assess the physical, cognitive, and psychological status, and will complete a needs assessment for both the patient and family caregiver. These will be used to guide the care protocols and development of the individualized care plan. The care plan is developed with an emphasis on coordinating services with the patient's providers. During the second visit, the individualized care plan is reviewed with the patient and family caregiver and revisions are made based on assessment outcomes. The 6-month Interaction Period: The coordinator and participant meet to revisit the care plan and to facilitate care. At the end of 6 months, all patients are transitioned to full care by their primary care and specialty physicians. |
| FG001 | 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. 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. |
| FG002 | 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. Caregiver Intervention: Caregivers of the participants will be assessed for caregiver burden at 3 time points. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 at the place of discharge. Participants receive direct interaction with a care coordinator to develop an individualized care plan. Frequent assessments 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 full care by their primary care and specialty physicians and their participation in this study will be ended. Care Coordinator Intervention for Direct Intervention Group: The coordinator will conduct a visit within 72 hours of discharge to assess the physical, cognitive, and psychological status, and will complete a needs assessment for both the patient and family caregiver. These will be used to guide the care protocols and development of the individualized care plan. The care plan is developed with an emphasis on coordinating services with the patient's providers. During the second visit, the individualized care plan is reviewed with the patient and family caregiver and revisions are made based on assessment outcomes. The 6-month Interaction Period: The coordinator and participant meet to revisit the care plan and to facilitate care. At the end of 6 months, all patients are transitioned to full care by their primary care and specialty physicians. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants were screened prior to being approached for enrollment. Only after informed consent was obtained were participants randomized to a group. The numbers reported are in the aggregate for those with liver disease only and not for a particular group. Data for caregivers were not tracked. | Posted | Count of Participants | Participants | Time of Enrollment |
|
6 months
We utilized the same verbiage to classify adverse events, both regular and serious as found in the clincialtrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 at the place of discharge. Participants receive direct interaction with a care coordinator to develop an individualized care plan. Frequent assessments 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 full care by their primary care and specialty physicians and their participation in this study will be ended. Care Coordinator Intervention for Direct Intervention Group: The coordinator will conduct a visit within 72 hours of discharge to assess the physical, cognitive, and psychological status, and will complete a needs assessment for both the patient and family caregiver. These will be used to guide the care protocols and development of the individualized care plan. The care plan is developed with an emphasis on coordinating services with the patient's providers. During the second visit, the individualized care plan is reviewed with the patient and family caregiver and revisions are made based on assessment outcomes. The 6-month Interaction Period: The coordinator and participant meet to revisit the care plan and to facilitate care. At the end of 6 months, all patients are transitioned to full care by their primary care and specialty physicians. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Orman | Indiana University | 317-278-1630 | esorman@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2021 | Apr 3, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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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.
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One member of the study team will randomize the participants and all other study personnel will remain blinded.
|
|
| 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. |
|
|
| Caregiver Intervention | Other | Caregivers of the participants will be assessed for caregiver burden at 3 time points. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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). | 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). | 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). | 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 | 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 |
| liver transplant |
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| transitioned to hospice care |
|
| BG001 | 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. 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. |
| BG002 | 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. Caregiver Intervention: Caregivers of the participants will be assessed for caregiver burden at 3 time points. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. 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. |
|
|
| Primary | 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. | Data for caregivers was not tracked. Of note we had no participants withdraw but a number were lost to follow-up. | Posted | Count of Participants | Participants | At drop out date or lost to follow-up date, which every comes first an average of 6 months |
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| Primary | 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. | Posted | Count of Participants | Participants | Through study completion, an average of 6 months |
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|
| Secondary | 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. | Information not measured for caregivers in this outcome. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | 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. | scores at initial enrollment for patients only; caregivers were not included in this measure | Posted | Mean | Standard Error | score on a scale | measure was completed at enrollment by patients only |
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| Secondary | 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. | scores at 3 month enrollment for patients only; caregivers were not included in this measure | Posted | Mean | Standard Error | score on a scale | measure was completed at 3 months by patients only |
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|
| Secondary | 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. | scores at 6 month enrollment for patients only; caregivers were not included in this measure | Posted | Mean | Standard Error | score on a scale | measure was completed at 6 months by patients only |
|
|
|
| Secondary | 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. | scores at initial enrollment by patients only; caregivers were not included in this measure | Posted | Mean | Standard Deviation | score on a scale | measure was completed at initial enrollment by patients only |
|
|
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| Secondary | 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. | scores at 3 months by patients only; caregivers were not included in this measure | Posted | Mean | Standard Deviation | score on a scale | measure was completed at 3 months by patients only |
|
|
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| Secondary | 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. | scores at 6 months by patients only; caregivers were not included in this measure | Posted | Mean | Standard Deviation | score on a scale | measure was completed at 6 months by patients only |
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| Secondary | Physical Performance | Assessment from the patient only through data collection from the Short Physical Performance Battery (SPPB) instrument. | measurement was not administered so no outcome data are available | Posted | measure was completed at initial enrollment by patients only |
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| Secondary | Physical Performance | Assessment from the patient only through data collection from the Short Physical Performance Battery (SPPB) instrument. | measurement was not administered so no outcome data are available | Posted | measure was completed at 3 months by patients only |
|
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| Secondary | Physical Performance | Assessment from the patient only through data collection from the Short Physical Performance Battery (SPPB) instrument. | measurement was not administered so no outcome data are available | Posted | measure was completed at 6 months by patients only |
|
|
| Secondary | 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. | scores at initial enrollment by patients only; caregivers were not included in this measure | Posted | Mean | Standard Deviation | units on a scale | measure was completed at initial enrollment by patients only |
|
|
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| Secondary | 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. | scores at 3 months by patients only; caregivers were not included in this measure | Posted | Mean | Standard Deviation | units on a scale | measure was completed at 3 months by patients only |
|
|
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| Secondary | 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. | scores at 6 months by patients only; caregivers were not included in this measure | Posted | Mean | Standard Deviation | units on a scale | measure was completed at 6 months by patients only |
|
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| Secondary | Cognitive Assessment With 3D CAM (Confusion Assessment Method) | Assessment of overall levels of cognitive status, including hepatic encephalopathy | measurement was not administered so no outcome data are available | Posted | measure was completed at initial enrollment by patients only |
|
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| Secondary | Cognitive Assessment With 3D CAM (Confusion Assessment Method) | Assessment of overall levels of cognitive status, including hepatic encephalopathy | measurement was not administered so no outcome data are available | Posted | measure was completed at 3 months by patients only |
|
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| Secondary | Cognitive Assessment With 3D CAM (Confusion Assessment Method) | Assessment of overall levels of cognitive status, including hepatic encephalopathy | measurement was not administered so no outcome data are available | Posted | measure was completed at 6 months by patients only |
|
|
| Secondary | 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). | scores at initial enrollment by patients only; caregivers were not included in this measure | Posted | Count of Participants | Participants | measure was completed at initial enrollment by patients only |
|
|
|
| Secondary | 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). | scores at 3 month enrollment by patients only; caregivers were not included in this measure | Posted | Count of Participants | Participants | measure was completed at 3 month enrollment by patients only |
|
|
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| Secondary | 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). | scores at 6 month enrollment by patients only; caregivers were not included in this measure | Posted | Count of Participants | Participants | measure was completed at 6 month enrollment by patients only |
|
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| Secondary | 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 | Caregivers of patients with liver disease who enrolled in the Cirrhosis Medical Home study were eligible for study enrollment. | Posted | Mean | Standard Deviation | units on a scale | 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 |
|
|
|
| 7 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. 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. | 6 | 20 | 0 | 20 | 0 | 20 |
| EG002 | 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. Caregiver Intervention: Caregivers of the participants will be assessed for caregiver burden at 3 time points. | 0 | 4 | 0 | 4 | 0 | 4 |
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |