Cirrhosis Medical Home
Phase: NA
Conditions: Cirrhosis, Liver
Sponsor: Indiana University

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Cirrhosis Medical Home 
 
Eric Orman, MD 
Division of Gastroenterology and Hepatology 
702 Rotary Circle, Suite 225 
Indianapolis, IN 46202 
 
 
 
 
Co-investigators: 
Malaz Boustani, MD 
Noll Campbell, PharmD, MS 
Nicole Fowler, PhD 
Archita Desai, MD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Support Provided by: 
NIDDK  
 
 
 
 
 

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Table of Contents: 
 
Study Schema 
1.0 
Background & Rationale 
2.0 
Objective(s) 
2.1 
Primary Objective 
2.2 
Secondary Objective 
3.0 
Study Measures 
3.1 
Primary Outcome Measure 
3.2 
Secondary Outcome Measures 
3.3 
Other Patient Measures 
3.4 
Other Caregiver Measures 
4.0 
Eligibility Criteria 
4.1 
Patients 
4.2 
Caregivers 
5.0 
Study Design 
6.0 
Enrollment/Randomization 
7.0 
Study Procedures 
8.0 
Study Personnel 
9.0 
Data Safety Monitoring 
10.0 Study Withdrawal/Discontinuation 
11.0 Statistical Considerations 
12.0 Data Management 
13.0 Privacy/Confidentiality Issues 
14.0 Follow-up and Record Retention 
15.0 References 
16.0 Appendices 
16.1 Schedule of Events 
16.2  Sample Care Plan 
 
 

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1.0 
Background & Rationale 
 
Every year, 150,000 Americans are hospitalized for complications of liver cirrhosis.2 
These patients suffer from debilitating symptoms (ascites, gastrointestinal bleeding, 
infection, and hepatic encephalopathy).3 They also have impairments in physical, 
cognitive, psychological, and social functions leading to poor quality of life and long-
term disability.1, 4-7 These impairments contribute to high utilization of health care 
resources; within 30 days of hospital discharge, 25% of patients are readmitted, and of 
these readmissions, 20-40% are preventable.8-10 This inpatient health care utilization is 
the largest driver of the $30 billion spent annually on chronic liver disease.11 These 
individual and societal burdens of cirrhosis could be improved with existing health care 
services, behavioral care, rehabilitation services, and community resources; but the 
current fragmented nature of the health care system does not allow for the necessary 
coordination to best care for this population.12 
 
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.13, 14 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.15-25 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.26 At Indiana University, researchers have over 20 years of 
experience in developing, testing, and implementing CCMs successfully for patients 
living with dementia or depression.15, 16 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 and to reduce acute health care utilization for patients with cirrhosis. In this pilot, 
randomized trial of 40 patients, we aim to refine our study processes in preparation for 
a large scale randomized controlled trial evaluating the efficacy of the Cirrhosis Medical 
Home in improving the quality of life of patients discharged from the hospital with 
cirrhosis.  Additionally, up to 40 caregivers will be enrolled in the trial. 
 
 
2.0 
Objective(s) 
2.1 
The primary objective of this trial is to test the screening and enrollment 
processes for a randomized controlled trial of the Cirrhosis Medical Home 
compared to usual care for patients with decompensated cirrhosis and 
poor quality of life when discharged from the hospital 
2.2 
Secondary objectives are: 

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2.2.1 to assess the data collection process, outcome assessment, and the 
acceptability of the Cirrhosis Medical Home trial 
2.2.2 to estimate the effect size of the Cirrhosis Medical Home 
intervention on quality of life at six months post hospital discharge 
 
 
3.0 
Study Measures 
All primary and secondary outcomes measures will be obtained from study 
participants at baseline and at 3 and 6 months, per the schedule of events. 
Additionally, MELD and Child-Pugh scores will also be obtained at the 3 and 6 
month assessments. 
 
3.1 
Primary Outcome (Feasibility) Measures 
3.1.1. Enrollment rate: The enrollment rate is the number of 
patients/caregivers enrolled per month. We will further determine the number of 
patients/caregivers screened and approached for enrollment. Based on these 
numbers, we will calculate the proportion of screened patients/caregivers eligible 
for enrollment, the proportion of eligible patients/caregivers approached, and the 
proportion of approached patients/caregivers enrolled. Of those not eligible, we 
will record reasons for ineligibility. Of those eligible, but not approached, we will 
record reasons. For those approached, but not enrolled, we will record reasons.  
3.1.2 Drop-out rate: The drop-out rate is the proportion of enrolled 
participants (patients and caregivers) who drop out of the study before 
completion. 
3.1.3 Data completion: We will record the completeness of the data collection 
for enrolled subjects. For those with incomplete data, we will record reasons that 
data could not be collected. 
 
3.2 
Secondary Outcome Measures 
3.2.1. Quality of Life: This outcome will be obtained from the patient only. 
Patient health–related QOL will be assessed using the Medical Outcome 
Study Short Form (SF-36).40, 48, 49 This scale has eight components 
(physical functioning, role-physical, bodily pain, general health, vitality, 
social functioning, role-emotional, and mental health) that are aggregated 
into a Physical Component Summary (PCS) and a Mental Component 
Summary (MCS). Changes that differ by 2 or more points on a scale of 0 
to 100 are clinically meaningful.49 
3.2.2  Physical Performance:  Physical performance measures will be 
obtained from the patient only. Physical recovery will be assessed via the 
Short Physical Performance Battery (SPPB), a validated objective 
assessment.50 The SPPB yields a performance score of 0-12 (0-4 poor, 5-7 
intermediate, 8-12 good). A difference of 1 point indicates significant 
change in function. The SPPB has been validated in patients with 
decompensated cirrhosis.51, 52 Grip strength will also be obtained to 
calculate the Liver Frailty Index, https://liverfrailtyindex.ucsf.edu, which 
overlaps with the SPPB. 

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3.2.3   Depression and Anxiety Symptoms: Depression and anxiety 
symptoms will be obtained from the patient only. The Patient Health 
Questionnaire-9 (PHQ-9)53, 54 and Generalized Anxiety Disorder Scale 
(GAD-7)55, 56 will be used to measure patient mood and anxiety. The PHQ-
9 is a nine-item depression scale with a total score from 0 to 27, and the 
GAD-7 is a seven-item anxiety scale with a total score from 0 to 21. Both 
of these scales are derived from the Patient Health Questionnaire, have 
good internal consistency and test–retest reliability as well as convergent, 
construct, criterion, procedural and factorial validity for the diagnosis of 
major depression and general anxiety disorder. 
3.2.4  Cognitive Assessment: Cognitive assessment will be obtained from 
the patient only. 3D CAM and PHES are psychometric measures of hepatic 
encephalopathy. They are quick, simple paper tests that are easily 
interpreted. They are components of the gold-standard Psychometric 
Hepatic Encephalopathy Score.57-60  
3.2.5 Caregiver Burden: Caregiver burden will be obtained from the 
caregiver only. The Zarit Burden Interview-12 (ZBI-12) is a validated 
instrument that has been utilized in various populations.61 It has excellent 
test characteristics when compared with the long form of the ZBI, and it 
has been used in other studies of cirrhosis.4, 62 
3.2.6 Acute Health Care Utilization: Health care utilization will be 
obtained from the patient only. In addition to patient-reported emergency 
room and admission data, we will use the Indiana University Health local 
data warehouse and the larger Indiana Network for Patient Care (INPC) to 
complement the utilization assessment. INPC is a large health information 
exchange in Indiana and provides data from all health care systems within 
the state.63 We will determine the number of emergency room visits and 
the number of hospitalizations within 6 months of discharge as well as 
associated diagnoses. As part of this, we will also be tracking admissions 
specific to COVID-19, due to the large impact the pandemic has had on 
our healthcare system. We will do that by tracking whether patients are 
admitted with a COVID-19 diagnosis or die of COVID-19 while enrolled in 
the study.  
3.2.7 CMH Interactions: In patients/caregivers randomized to the 
Cirrhosis Medical Home, we will record the numbers, timing, and types of 
interactions with the care coordinator (in-person, phone, video, other 
forms of communication). We will also record the use of interventions 
(e.g. care protocols, pharmacologic treatments). 
3.2.8 Palliative Care outcomes: Palliative care referrals will be 
recorded, including presence of a referral order, successful attendance at 
a palliative care visit, completion of advanced directives, and place of 
death. 
 
3.3 
Other Patient Measures: At baseline, we will measure age, race, gender, 

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level of education, income, employment, family size and household 
composition, height, weight, etiology of cirrhosis, liver disease severity 
(Child-Pugh score,64 MELD score65), Charlson comorbidity index,66 
medications, prior health care utilization, and reason for hospital 
admission. 
 
3.4 
Other Caregiver Measures: At baseline, we will measure age, race, 
gender, location (living with the patient or elsewhere), relationship to 
patient, and length of time caring for the patient. 
 
The results of this study will establish the feasibility of performing a randomized 
trial to evaluate the efficacy of the Cirrhosis Medical Home in improving QOL for 
patients with decompensated cirrhosis. The next step will be to conduct a large-
scale efficacy trial. 
 
4.0 
Eligibility Criteria 
4.1 
Patients 
4.1.1 Inclusion Criteria 
• Age ≥18 years 
• Cirrhosis based on: 
o biopsy  
o characteristic clinical, laboratory, and imaging findings 
• Decompensated cirrhosis as denoted by any of the following:  
o active ascites requiring paracentesis during hospitalization  
o active overt hepatic encephalopathy requiring lactulose during 
hospitalization  
o active hepatic hydrothorax requiring thoracentesis during 
hospitalization 
• Poor quality of life as defined by: 
SF-36 Physical and/or Mental Component Summary scale <40 (1SD 
below the mean of healthy subjects)1, 40 
• 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 
 
4.1.2 Exclusion Criteria 
• Solid organ transplant of any organ 
• History of dementing illnesses and other neurodegenerative diseases 
such as Alzheimer’s disease, Parkinson’s disease, or vascular dementia 
• Unable to complete study questionnaire due to hearing loss 
• Legally blind 
• Pregnant or nursing 
• Incarcerated 

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• Concurrent enrollment in a related interventional research study 
 
4.2 
Caregivers 
4.2.1 Inclusion Criteria 
• Age ≥18 years 
• Identified caregiver of patient 
• Able to be consented, either in person or through legally authorized 
representative 
• Access to a telephone 
 
4.2.2 Exclusion Criteria 
• Impaired cognitive function 
• Unable to complete study questionnaire due to hearing loss 
• Legally blind 
• Incarcerated 
 
 
5.0 
Study Design 
 
This is a pilot, randomized controlled trial to establish the feasibility of enrollment, data 
collection, and outcome assessment for a future efficacy trial. Participants will be 
enrolled and randomized to the Cirrhosis Medical Home or usual care at the time of 
hospital discharge and will be followed for 6 months. 
 
The goal of this proposal is to establish the feasibility of a randomized controlled trial 
comparing the Cirrhosis Medical Home to usual care in improving QOL and health care 
utilization of patients with decompensated cirrhosis and poor QOL. To achieve this goal, 
we propose a feasibility study in which we will randomize 40 patients to the Cirrhosis 
Medical Home or usual care, assessing QOL; physical, cognitive, and psychological 
symptoms; and health care utilization. Figure 1 shows the conceptual model.38 We 
hypothesize that the Cirrhosis Medical Home will improve QOL through its effects on 
physical, psychological, and cognitive recovery, and that this improvement in QOL will 
result in decreased health care utilization. 
 
 
 

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In addition, 40 caregivers of people with cirrhosis will be enrolled in the study.  They 
will complete the Zarit Burden Interview-12 (ZBI-12) at baseline, 3 months and 6 
months.  For those caregivers who care for participants who are randomized into the 
CMH arm, the caregivers will complete the HABC-M Caregiver assessment during their 
interactions with the CMH care coordinator. The HABC-M for the Caregiver is not a 
study outcome but is an assessment that the care coordinator uses to help guide the 
individualized care plan for the patient. 
 
6.0 
Enrollment/Randomization 
 
Research staff will review the hepatology inpatient census each day, and eligible 
patients will be approached during their hospital stay. On or close to the day of hospital 
discharge and after obtaining informed consent, research staff will complete the 
Baseline Assessment and obtain baseline measurements in all enrolled subjects in both 
intervention and control arms. Subjects will then be randomized via a computer-
generated randomization scheme into the Cirrhosis Medical Home or usual care by 
separate personnel who will not be involved in outcomes assessments. Research staff 
who are completing study assessments will be blinded to the assignment. Research 
staff will be trained research study personnel in the Division of Gastroenterology who 
will be specifically trained in the study measures. Our research assistants will be trained 
not to inquire about study assignments. They will be conducting structured assessments 
that do not provide room for qualitative interviewing that should prevent unblinding. 
They will not be involved in study assignments and treatment administrations. Subjects 
will be instructed not to discuss their therapy with the research assistants. 
 
7.0 
Study Procedures 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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ARM 1: Cirrhosis Medical Home 
 
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 face-to-face, telephone, or virtual visit with the patient at 
their place of discharge. This step is important for relationship-building. 
 
The First Visit: The care coordinator will conduct a face-to-face, telephone, or virtual 
visit at the patient’s location (e.g. home, skilled nursing facility) within 72 hours of 
hospital discharge. The coordinator will assess the patient’s physical, cognitive, and 
psychological status, and will complete a needs assessment for both the patient and 
family caregiver. All measures performed by the care coordinator will be used to guide 
the use of care protocols and development of the individualized care plan. These 
measures are different from the outcomes measures. The coordinator will also reconcile 
all medications. The Anticholinergic Cognitive Burden Scale will be completed by study 
staff. The coordinator will make note of scheduled and recommended appointments and 
will document initial and follow-up visits in the care coordination support software. 
 
Individualized Care Plan: The care plan will be developed with an emphasis on 
coordinating services with the patient’s providers. Using the assessments from the first 
visit, the coordinator will collaborate with the Cirrhosis Medical Home interdisciplinary 
team and the primary care providers to finalize the individualized care plan. This plan 
will be created through consultation and discussion between the care coordinator and 
interdisciplinary team using the assessments as guides. The assessments do not 
automatically trigger protocols or handouts, and there are no firm cutoffs on any of the 
assessments that would require any specific action. Rather, the assessments will be 
used to facilitate development of the care plan within the context of the patient’s 
unique individual circumstances. The assessments will also be used to assess for 
response to any intervention provided, so that appropriate changes to the care plan can 
be made in a timely fashion. If a patient does not have a participating caregiver, then 
no caregiver protocols or handouts will be used. Finally, the care coordinator will 
schedule a second face-to-face, telephone, or virtual visit within two weeks of the first 
visit. 
 
The Second Visit: During the second visit, the coordinator will review the individualized 
care plan with both the patient and the family caregiver. This process will include a) 
reviewing diagnoses; b) reviewing monitoring processes; c) implementation of care 
protocols; d) explanation of the corresponding educational handouts (patient and family 
caregiver); and e) connection to in-home services and community resources. 
 
The 6-month Interaction Period: Follow-up includes a 6-month interaction period 
between the care coordinator, the patients, and the family caregivers via face-to-face 
visits, phone contact, email, fax, or mail. The minimum amount of contact will be every 

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two weeks. During these interactions, the coordinator will answer questions; collect 
patient and caregiver feedback; reconcile medications and discuss adherence; review 
appointments and care plans; have the patient and the caregiver complete the HABC 
Monitor to trigger the use of care protocols; and facilitate access to community 
resources. Additional measures, described in the schedule of events, may be repeated 
depending on the individualized care plan, active issues, and needs as determined by 
the study team. The plan will be amended through consultation and discussion between 
the care coordinator and interdisciplinary team using the assessments as guides. The 
assessments do not automatically trigger protocols or handouts and there are no firm 
cutoffs on any of the assessments that would require any specific action. Rather, the 
assessments will be used to facilitate development of the care plan within the context of 
the patient’s unique individual circumstances. The assessments will also be used to 
assess for response to any intervention provided, so that appropriate changes to the 
care plan can be made in a timely fashion. Throughout the follow-up phase, the 
coordinator will work with patients, caregivers, the Cirrhosis Medical Home team, and 
the patient’s physicians to monitor, implement, and revise the individualized care plan. 
Such revisions could include introducing discussions about hospice care for patients who 
develop indications for hospice referral during follow-up. The Cirrhosis Medical Home 
team and coordinator will meet weekly to discuss new patients and monitor progress. If 
a patient requires hospitalization, the team activates the acute care transition phase 
where the coordinator contacts the hospital team and provides relevant information 
about the patient’s symptoms, as well as the patient’s most updated medication list. 
Following any hospital discharge, the coordinator will conduct a home, telephone, or 
virtual visit within 72 hours to reconcile medications and coordinate the post-discharge 
care plan. At the end of 6 months, all patients will be transitioned to receive full care by 
their primary care and specialty physicians. 
 
ARM 2: Usual 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. 
 
Outcome Assessment (Both Arms) 
Outcome measures will be obtained by blinded research staff from all enrolled subjects 
at baseline, 3 months, and 6 months. Baseline assessments will be completed in the 
hospital at the time of enrollment. Outcomes at 3 and 6 months will be completed in 
person. If participants are not able to attend in person, measures that can be 
performed remotely will be done via phone or videoconference. 
 

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8.0 
Study Personnel 
8.1 
Research Staff 
8.1.1. Recruitment Staff/Assessors: Trained research staff from the 
Division of Gastroenterology will be trained to administer the study 
measures in Section 3. They will recruit patients, obtain informed consent, 
complete the Baseline Assessment and measurements at the time of 
enrollment. They will be blinded to the study assignment as detailed in 
Section 6. They will also complete outcomes assessments at 3 and 6 
months. 
 
8.1.2. Randomization Staff: A separate member of the research team 
will be responsible for randomization so that the outcomes assessors will 
be blinded to the assignment. 
 
8.2 
Care Coordinator 
The coordinator is a registered nurse whose scope of practice includes 
health coaching, case management, community organization, and nursing 
care. The coordinator will conduct home visits; collaborate with the 
interdisciplinary team; communicate with the patient’s physicians; conduct 
root-cause analysis for unplanned acute care; implement individualized 
care plans; and monitor the care plans’ effectiveness. The coordinator will 
be supervised by the interdisciplinary team. This person will conduct face 
to face, telephone, or virtual visit with those in the intervention arm in the 
hospital, within 72 hours of discharge, and again within 2 weeks (the first 
and second visits). They will meet with the CMH interdisciplinary team 
weekly throughout the study to review patients. They will assess patients 
using the several instruments detailed in the schedule of events, which 
will be used to help develop individualized care plans and which will be 
used to guide specific care protocols. They will interact with study 
participants at least every 2 weeks during the 6-month follow-up period. 
For those randomized to usual care, they will help ensure follow-up after 
discharged as detailed in Section 7, but will not have any further contact 
with study participants. The care coordinator will not perform any of the 
outcomes assessments. The coordinator will be trained in all study 
procedures and instruments. 
 
8.3 
CMH Interdisciplinary Team 
The Cirrhosis Medical Home support team will consist of two hepatologists 
(Drs. Orman and Desai), a geriatrician with expertise in collaborative care 
(Dr. Boustani), a health services researcher (Dr. Fowler), and a 
pharmacist (Dr. Campbell). The team will meet weekly with the care 
coordinator. Dr. Orman will be accessible to the coordinator through 
phone or pager at all times. The team will supervise the care coordinator 
and ensure appropriate care. 

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9.0 
Data Safety Monitoring 
 
This is a minimal risk study and not a drug treatment trial.  As such, adverse events are 
expected to be minimal in both number and nature.  However, all such events or other 
subject problems/complications will be reported in accordance with federal, state, local, 
and university guidelines.   
 
10.0 Study Withdrawal/Discontinuation 
 
Participants who choose to withdraw from the study will do so by contacting the study 
coordinator or Dr. Orman directly at 317-278-1630.  This information will be given to 
participants as part of the informed consent process and ongoing communication 
between participants and study staff. 
 
11.0 Statistical Considerations 
 
This is a pilot trial for feasibility and effect size estimation. The plan is to enroll 40 total 
patients and randomize in 1:1 ratio to the Cirrhosis Medical Home and usual care. As a 
pilot trial, the study is not powered to test efficacy, but is designed to generate 
preliminary data to support a larger future trial. The sample size of 40, enrolled over 9 
months (see study timeline in section 13), will allow for recruitment of approximately 
one patient/caregiver dyad per week. Data collected from this pilot will be used to 
provide an estimate of intervention effect, i.e. the difference in the primary outcome 
measure (SF-36) between intervention and control groups. The pilot data will also 
provide estimates on variability in the outcome measures in this patient population. The 
effect and variability estimates from the pilot data will be used to power a large trial. 
The sample size of 40 will provide 80% probability that the 95% confidence interval for 
the estimated treatment difference with half-width of 0.7SD will contain the true 
treatment effect. The pilot sample size of 40 has also been shown to minimize the 
overall sample size of the pilot and the main trial together with 80% power in the main 
trial to detect effect sizes in the range of 0.1~0.3SD.67 
 
 
12.0 Statistical Data Management 
 
Primary data will be collected from conversations with the participants, both in person 
and via the telephone, as well as direct data capture from study instruments and the 
EMR and stored electronically in REDCap.  The storage location will be backed up 
automatically, manually every day per REDCap standard procedures.  Other data 
sources include outside medical record and lab data, data from INPC that will be stored 
in separate electronic files and merged with the primary data as needed.  Quality 
assurance steps will include built in range checks and testing of database by study team 
prior to moving to production mode. The following quality control methods will be used:  

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single entry with random checks of accuracy and extraction and cleaning of data that 
will be used for analysis approximately every 6 months. 
 
13.0 Privacy/Confidentiality Issues 
 
All study visits will be conducted in a private room with the door closed.  Nonetheless, 
there is a risk of loss of confidentiality.  Risks will be mitigated by conducting study 
visits in a private location.  All paper data will be stored in locked cabinets in a locked 
area.  Electronic data are entered and stored into a password protected database. Only 
authorized personnel will have access to the study data, in both paper and electronic 
format. 
 
 
14.0 Follow-up and Record Retention 
 
Subject participation will last 6 months and the entire duration of the study should take 
about 2 years.  Study records and study data will be retained and destroyed in 
accordance with federal, state, local, and university guidelines. 
 
 
Year 1 
Year 2 
 
1 
2 
3 
4 
1 
2 
3 
4 
Start-up 
 
 
 
 
 
 
 
 
Enrollment 
 
 
 
 
 
 
 
 
Intervention 
 
 
 
 
 
 
 
 
Outcome measures 
 
 
 
 
 
 
 
 
Data entry 
 
 
 
 
 
 
 
 
Data analysis 
 
 
 
 
 
 
 
 
R01 Preparation 
 
 
 
 
 
 
 
 
 
 
 
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16.0 Appendices 
16.1 Schedule of Events 
16.2 Sample Care Plan 
 

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16.1 Schedule of Events 
 
Assessment 
Baseline 
Initial 
Evaluation 
First 
Visit 
Second 
Visit 
Week 
4 
CMH Interaction* 
3 
Month 
CMH Interaction* 
6 
Month 
Week† 
0 
0 
72 hr 
2 
 
4 
6 
8 10 12 
 
14 16 18 20 22 24 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Height/weight 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cirrhosis 
etiology 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
MELD 
X 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
Child-Pugh 
X 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
CCI 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medications 
X 
 
X 
X 
 
X X X 
X 
X 
 
X 
X 
X 
X 
X 
X 
 
Reason for 
admission 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SF-36 
X 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
SPPB/LFI 
X 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
C-SSRS 
 
 
 
/ 
 
/ 
/ 
/ 
/ 
/ 
 
/ 
/ 
/ 
/ 
/ 
/ 
 
PHQ-9 
X 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
GAD-7 
X 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 PHES 
X 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
ZBI-12 
X 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
Utilization 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
HABC-M Self 
 
X1 
 
X 
 
X X X 
X 
X 
 
X 
X 
X 
X 
X 
X 
 
HABC-M 
Caregiver 
 
X1 
 
X 
 
X X X 
X 
X 
 
X 
X 
X 
X 
X 
X 
 
MMSE 
 
X1 
 
/ 
 
/ 
/ 
/ 
/ 
/ 
 
/ 
/ 
/ 
/ 
/ 
/ 
 
TUG 
 
X1 
 
/ 
 
/ 
/ 
/ 
/ 
/ 
 
/ 
/ 
/ 
/ 
/ 
/ 
 
HADS 
 
X1 
 
/ 
 
/ 
/ 
/ 
/ 
/ 
 
/ 
/ 
/ 
/ 
/ 
/ 
 
PEG 
 
X1 
 
/ 
 
/ 
/ 
/ 
/ 
/ 
 
/ 
/ 
/ 
/ 
/ 
/ 
 
3D CAM 
 
X1 
 
/ 
 
/ 
/ 
/ 
/ 
/ 
 
/ 
/ 
/ 
/ 
/ 
/ 
 
Stroop 
 
X1 
 
/ 
 
/ 
/ 
/ 
/ 
/ 
 
/ 
/ 
/ 
/ 
/ 
/ 
 
AUDIT-C 
 
X1 
 
/ 
 
/ 
/ 
/ 
/ 
/ 
 
/ 
/ 
/ 
/ 
/ 
/ 
 
PACS 
 
/1 
 
/ 
 
/ 
/ 
/ 
/ 
/ 
 
/ 
/ 
/ 
/ 
/ 
/ 
 
*Interaction contacts may be in-person or via phone. 

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†Timing is approximate. The First Visit is within 72 hours of hospital discharge. The Second Visit is within 2 weeks of the First 
Visit. CMH Interactions occur a minimum of every 2 weeks. 
X = required (HABC-M Caregiver only if caregiver enrolled) 
/ = optional, depending on clinical circumstance 
X1 = can be performed at initial evaluation or first visit 
 
Performed by Blinded Research Staff for all enrolled subjects 
 
Performed by CMH Care Coordinator only for those randomized to the Cirrhosis Medical Home 
 
Patient assessments 
 
Caregiver assessments 
Abbreviations: MELD, Model for End-Stage Liver Disease; CCI, Charlson Comorbidity Index; SF-36, Short Form Survey; SPPB, Short Physical 
Performance Battery; LFI, Liver Frailty Index; PHQ-9, Patient Health Questionnaire; GAD-7, Generalized Anxiety Disorder;; ZBI-12, Zarit Burden 
Interview; HABC-M, Healthy Aging Brain Care Monitor; MMSE, Mini-Mental Status Examination; TUG, Timed Up-and-Go; HADS, Hospital Anxiety and 
Depression Scale; PEG, Pain, Enjoyment, General Activity Scale; 3D CAM-, Confusion Assessment Method for the ICU 
 

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16.2  Sample Care Plan 
 
Study ID #:  
Age:  
 
 
 
 
 
 
 
 
 
Gender:  
Occupation:  
Educ:  
3 m 
 
 
6 m 
 
9 m 
 
 
12m Ethnicity:  
Instrument 
7/11 
10/5 10/19 11/2 2/27 3/28 5/23 6/27 7/24 9/13 
Targets 
MMSE 
Orientation Time 
Orientation Place  
Registration 
Attention & 
Calculation 
Recall 
Naming 
Repetition 
Comprehension 
Reading  
Writing 
Drawing 
Total 
- 
5/5 
5/5 
3/3 
5/5 
3/3 
2/2 
1/1 
3/3 
1/1 
1/1 
1/1 
30 
 
 
 
- 
5/5 
5/5 
3/3 
5/5 
3/3 
2/2 
1/1 
3/3 
1/1 
1/1 
1/1 
30 
 
 
 
 
- 
5/5 
5/5 
3/3 
5/5 
3/3 
2/2 
1/1 
3/3 
1/1 
1/1 
1/1 
30 
- 
 
 
 
 
 
 
 
 
 
 
 
>27 
HADS 
Anxiety 
Depression 
- 
13 
7  
- 
9 
2 
 
 
- 
7 
0 
 
- 
0 
0 
 
 
- 
0 
0 
- 
<7 
<7 
TUG 
UTC 
UTC 
 
 
UTC 
 
UTC 
 
 
UTC 
<9 sec 
PEG 
4.33 
3.33 
2.3 
2 
1.66 2.33 2.66 2.33 
0 
2.33 
<4 
3D CAM 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
<20 
Stroop 
 
 
 
 
 
 
 
 
 
 
<190 
HABC-SRM 
Cognitive 
Functional 
Behavioral & Mood 
Total 
- 
2 
3 
8 
13 
- 
0 
0 
8 
8 
- 
0 
0 
5 
5 
- 
0 
0 
2 
2 
- 
0 
1 
1 
2 
- 
0 
0 
0 
0 
- 
0 
0 
0 
0 
- 
0 
0 
0 
0 
- 
0 
0 
0 
0 
- 
0 
0 
0 
0 
- 
<4 
<3 
<5 
<14 
Score 1 
Score 2 
Score 3 
Total ACB 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
 
 
 
<2 
 
Care Coordinator suggests implementing highlighted protocols below 
Protocols: 
1. Cognition 
2. Exercise 
3. Depression 
4. Anxiety 

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5. Physical Health 
6. Behavioral Care 
7. Legal and Financial 
8. Communication 
9. Mobility 
10. Personal Care 
11. Sleep Disturbance 
12. Pain 
13. Stress 
14. Acute Care Reduction/DELIRIUM 
15. Medication Adherence 
16. Ascites/Edema 
17. Hepatic Encephalopathy 
18. Alcohol and Substance Use Disorder Protocol 
Care Plan: 
1. Counseling (Prognosis & Natural History) 
2. Enhancing Knowledge  
3. Brain Exercises / Cognitive Rehabilitation 
4. Physical Exercise / Physical Rehabilitation 
5. Time-Off Caregiving Tasks (minimum of 8 hours per week) 
6. Belonging to Support Group 
7. Counseling (Coping with Disease Disability) 
8. Respite Care 
9. Medication Adherence Support 
10. Referral or starting Cognitive Behavioral Therapy 
11. Referral or starting Problem Solving Therapy 
12. Referral for Family Therapy 
13. Referral for Home Health Care Services 
14. Referral to Adult Day Care 
15. Referral for Driving Evaluation / Rehab 
16. Recommend Residing in Assisted Living  
17. Referral to Elder Low Attorney 
18. Referral to Elder Abuse Agency Investigation 
19. Referral for Guardianship 
20. Counseling for Advance Directives 
21. Prescribe ChEI 
 
22. Prescribe Antidepressants 
 
23. Prescribe Vascular Burden Reduction 
24. Reduce Anticholinergic Burden 
25. Prescribe Anxiolytics 
26. Prescribe Sleep Medication 
27. Prescribe Other