Trial Outcomes & Findings for Cirrhosis Medical Home (NCT NCT04581369)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

Time of Enrollment

Results posted on

2024-07-17

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	20	20	4
Overall Study COMPLETED	4	4	4
Overall Study NOT COMPLETED	16	16	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Death	7	6
Overall Study Lost to Follow-up	7	3
Overall Study liver transplant	2	2
Overall Study transitioned to hospice care	0	5

Baseline Characteristics

Cirrhosis Medical Home

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Direct Intervention n=20 Participants 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.	Standard of Care n=20 Participants 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.	Caregiver n=4 Participants 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.	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	15 Participants n=7 Participants	3 Participants n=5 Participants	32 Participants n=4 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	12 Participants n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	15 Participants n=7 Participants	2 Participants n=5 Participants	29 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	15 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	20 Participants n=7 Participants	4 Participants n=5 Participants	44 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	19 Participants n=7 Participants	4 Participants n=5 Participants	42 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	4 participants n=5 Participants	44 participants n=4 Participants

PRIMARY outcome

Timeframe: Time of Enrollment

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Direct Intervention n=67 Participants 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.	Standard of Care n=67 Participants 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.	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.
Enrollment Rate	20 Participants	20 Participants	—

PRIMARY outcome

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

Population: Data for caregivers was not tracked. Of note we had no participants withdraw but a number were 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.

Outcome measures

Outcome measures
Measure	Direct Intervention n=20 Participants 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.	Standard of Care n=20 Participants 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.	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.
Number of Participants Who Dropped Out or Are Lost to Follow-up	3 Participants	7 Participants	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Direct Intervention n=20 Participants 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.	Standard of Care n=20 Participants 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.	Caregiver n=4 Participants 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.
Number of Participants With Complete Data	4 Participants	4 Participants	4 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Information not measured for caregivers in this outcome.

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.

Outcome measures

Outcome measures
Measure	Direct Intervention n=20 Participants 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.	Standard of Care n=20 Participants 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.	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.
Acute Health Care Utilization	17 Participants	18 Participants	0 Participants

SECONDARY outcome

Timeframe: measure was completed at enrollment by patients only

Population: scores at initial enrollment for patients only; caregivers were not included in this measure

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.

Outcome measures

Outcome measures
Measure	Direct Intervention n=20 Participants 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.	Standard of Care n=20 Participants 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.	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.
Health Related Quality of Life: Medical Outcome Study Short Form (SF-36)	56 score on a scale Standard Error 0.7	58 score on a scale Standard Error 0.7	—

SECONDARY outcome

Timeframe: measure was completed at 3 months by patients only

Population: scores at 3 month enrollment for patients only; caregivers were not included in this measure

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.

Outcome measures

Outcome measures
Measure	Direct Intervention n=6 Participants 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.	Standard of Care n=6 Participants 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.	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.
Health Related Quality of Life: Medical Outcome Study Short Form (SF-36)	84 score on a scale Standard Error 0.8	88 score on a scale Standard Error 0.4	—

SECONDARY outcome

Timeframe: measure was completed at 6 months by patients only

Population: scores at 6 month enrollment for patients only; caregivers were not included in this measure

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.

Outcome measures

Outcome measures
Measure	Direct Intervention n=4 Participants 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.	Standard of Care n=4 Participants 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.	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.
Health Related Quality of Life: Medical Outcome Study Short Form (SF-36)	102 score on a scale Standard Error 0.5	100 score on a scale Standard Error 0.7	—

SECONDARY outcome

Timeframe: measure was completed at initial enrollment by patients only

Population: scores at initial enrollment by patients only; caregivers were not included in this measure

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.

Outcome measures

Outcome measures
Measure	Direct Intervention n=20 Participants 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.	Standard of Care n=20 Participants 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.	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.
Depression Symptoms	11 score on a scale Standard Deviation 0.044	14 score on a scale Standard Deviation 0.11	—

SECONDARY outcome

Timeframe: measure was completed at 3 months by patients only

Population: scores at 3 months by patients only; caregivers were not included in this measure

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.

Outcome measures

Outcome measures
Measure	Direct Intervention n=12 Participants 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.	Standard of Care n=12 Participants 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.	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.
Depression Symptoms	14 score on a scale Standard Deviation 0.15	14 score on a scale Standard Deviation 0.11	—

SECONDARY outcome

Timeframe: measure was completed at 6 months by patients only

Population: scores at 6 months by patients only; caregivers were not included in this measure

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.

Outcome measures

Outcome measures
Measure	Direct Intervention n=4 Participants 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.	Standard of Care n=4 Participants 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.	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.
Depression Symptoms	12 score on a scale Standard Deviation 0.2	18 score on a scale Standard Deviation 0.18	—

SECONDARY outcome

Timeframe: measure was completed at initial enrollment by patients only

Population: measurement was not administered so no outcome data are available

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measure was completed at 3 months by patients only

Population: measurement was not administered so no outcome data are available

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measure was completed at 6 months by patients only

Population: measurement was not administered so no outcome data are available

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measure was completed at initial enrollment by patients only

Population: scores at initial enrollment by patients only; caregivers were not included in this measure

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.

Outcome measures

Outcome measures
Measure	Direct Intervention n=9 Participants 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.	Standard of Care n=12 Participants 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.	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.
Anxiety Symptoms	7 units on a scale Standard Deviation 0.11	9 units on a scale Standard Deviation 0.11	—

SECONDARY outcome

Timeframe: measure was completed at 3 months by patients only

Population: scores at 3 months by patients only; caregivers were not included in this measure

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.

Outcome measures

Outcome measures
Measure	Direct Intervention n=7 Participants 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.	Standard of Care n=18 Participants 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.	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.
Anxiety Symptoms	14 units on a scale Standard Deviation 0.11	14 units on a scale Standard Deviation 0.15	—

SECONDARY outcome

Timeframe: measure was completed at 6 months by patients only

Population: scores at 6 months by patients only; caregivers were not included in this measure

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.

Outcome measures

Outcome measures
Measure	Direct Intervention n=12 Participants 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.	Standard of Care n=18 Participants 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.	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.
Anxiety Symptoms	16 units on a scale Standard Deviation 0.2	16 units on a scale Standard Deviation 0.2	—

SECONDARY outcome

Timeframe: measure was completed at initial enrollment by patients only

Population: measurement was not administered so no outcome data are available

Assessment of overall levels of cognitive status, including hepatic encephalopathy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measure was completed at 3 months by patients only

Population: measurement was not administered so no outcome data are available

Assessment of overall levels of cognitive status, including hepatic encephalopathy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measure was completed at 6 months by patients only

Population: measurement was not administered so no outcome data are available

Assessment of overall levels of cognitive status, including hepatic encephalopathy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measure was completed at initial enrollment by patients only

Population: scores at initial enrollment by patients only; caregivers were not included in this measure

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

Outcome measures

Outcome measures
Measure	Direct Intervention n=18 Participants 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.	Standard of Care n=17 Participants 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.	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.
Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) score >-5	7 Participants	3 Participants	—
Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) score ≤-5	11 Participants	14 Participants	—

SECONDARY outcome

Timeframe: measure was completed at 3 month enrollment by patients only

Population: scores at 3 month enrollment by patients only; caregivers were not included in this measure

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

Outcome measures

Outcome measures
Measure	Direct Intervention n=3 Participants 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.	Standard of Care n=4 Participants 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.	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.
Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) score >-5	3 Participants	3 Participants	—
Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) score ≤-5	0 Participants	1 Participants	—

SECONDARY outcome

Timeframe: measure was completed at 6 month enrollment by patients only

Population: scores at 6 month enrollment by patients only; caregivers were not included in this measure

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

Outcome measures

Outcome measures
Measure	Direct Intervention n=2 Participants 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.	Standard of Care n=2 Participants 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.	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.
Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) score >-5	2 Participants	1 Participants	—
Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) score ≤-5	0 Participants	1 Participants	—

SECONDARY outcome

Timeframe: 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

Population: Caregivers of patients with liver disease who enrolled in the Cirrhosis Medical Home study were eligible for study enrollment.

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

Outcome measures

Outcome measures
Measure	Direct Intervention n=4 Participants 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.	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.	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.
Caregiver Burden	10 units on a scale Standard Deviation 0.5	—	—

Adverse Events

Direct Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 7 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

Caregiver

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eric Orman

Indiana University

Phone: 317-278-1630

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place