Cirrhosis Medical Home

Not Applicable

Completed

Conditions: Cirrhosis, Liver

Interventions: Other: Care Coordinator Intervention for Direct Intervention Group
Other: Care Coordinator Intervention for Standard of Care Group
Other: Caregiver Intervention

Registration Number: NCT04581369

Lead Sponsor: Indiana University

Brief Summary: To address the health care system's lack of care coordination, the Institute of Medicine and Centers for Medicare and Medicaid Services recommend the development of collaborative care models (CCM) in a wide range of clinical settings. CCMs are intended to provide coordinated, personalized care pragmatically using care coordinators. CCMs have successfully improved care in multiple patient populations, ranging from frail older adults to depression. In contrast, for patients with cirrhosis, there is a paucity of data to support the benefit of CCM in this medically complex and vulnerable population. At Indiana University, researchers have over 20 years of experience in developing, testing, and implementing CCMs successfully for patients living with dementia or depression. Building on these successes, we have customized the CCM to best meet the unique and complex biopsychosocial needs of patients with cirrhosis: the Cirrhosis Medical Home.

Detailed Description: In the Cirrhosis Medical Home, a care coordinator, supported by an interdisciplinary clinical team, will deliver a personalized intervention guided by a set of innovative tools: (i) patient-centered care protocols, (ii) a mobile office, (iii) care coordination support software, and (iv) dynamic feedback measures.

The overall goal is to improve quality of life of patients discharged from the hospital with cirrhosis and to reduce acute health care utilization for patients with cirrhosis.

Additionally, up to 40 caregivers will be enrolled in the trial.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct Intervention	Care Coordinator Intervention for Direct Intervention Group	Initial Evaluation: Prior to discharge, the care coordinator will review the hospital discharge plan, obtain the approval of the patient's physicians to co-manage the patient's care, and schedule a visit with the patient at their place of discharge. Participants in this arm will receive direct interaction with a care coordinator to develop an individualized care plan. Frequent assessments, at least once every two weeks, will occur to continue to follow or to modify the care plan based on the needs of the patient. At the end of 6 months, all patients will be transitioned to receive full care by their primary care and specialty physicians and their participation in this study will be ended.
Standard of Care	Care Coordinator Intervention for Standard of Care Group	Prior to hospital discharge, the care coordinator will identify the primary care and/or hepatology provider of patients in the usual care group and will ensure follow up appointments at the time of hospital discharge. The coordinator will compose and send a letter to the primary care and/or hepatology provider summarizing the patient's diagnosis, hospital course, discharge medications, and the plan of follow-up care. If the patient does not already have a primary care or hepatology provider, the coordinator will work with the patient to identify a new provider. Subjects in this group will receive no further intervention.
Caregiver	Caregiver Intervention	The caregivers of people with cirrhosis will be enrolled in the study. They will complete the assessments at baseline, 3 months and 6 months.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Complete Data	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.
Enrollment Rate	Time of Enrollment	The proportion of screened patients eligible, approached and enrolled will be calculated. This is an internal assessment relating not to participants but to department specific metrics.
Number of Participants Who Dropped Out or Are Lost to Follow-up	At drop out date or lost to follow-up date, which every comes first an average of 6 months	This is the proportion of enrolled participants (patients) who drop out of the study before completion. This is an internal assessment relating not to participants but to department specific metrics.

Secondary Outcome Measures

Name	Time	Method
Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score)	measure was completed at 6 month enrollment by patients only	Assessment of overall levels of cognitive status, including hepatic encephalopathy. PHES range is -18 to +6. Normal is \> -4 (better). \<= -5 is abnormal (worse).
Cognitive Assessment With 3D CAM (Confusion Assessment Method)	measure was completed at 6 months by patients only	Assessment of overall levels of cognitive status, including hepatic encephalopathy
Caregiver Burden	caregivers completed at initial enrollment--while the plan was to complete at 3 and 6 months, none of the participants with liver disease for whom these people cared were alive at the 3 and 6 month mark so the instruments were not completed	Assessment from caregivers only through data collection from the Zarit Burden Interview-12 (ZBI-12) instrument; a lower score is generally indicative of a lower amount caregiver fatigue or perception of burden; a higher score generally correlates to a greater level of caregiver fatigue/perceived burden. 0-10 no burden, 10-20 mild-moderate burden, \>20 high burden. Minimum: 0 Maximum: 48
Health Related Quality of Life: Medical Outcome Study Short Form (SF-36)	measure was completed at 6 months by patients only	Assessment from the patient only through data collection from the Medical Outcome Study Short Form (SF-36) instrument. This 36 item questionnaire has a minimum score of 36 with a maximum score of 180; a higher score generally correlates to poorer health. This assessment was for patients only and not for caregivers.
Depression Symptoms	measure was completed at 6 months by patients only	Assessment from patient only through data collection from the Patient Health Questionnaire-9 (PHQ-9) instrument. This 9 item instrument that assesses depression and has a minimum score of 0 and a maximum score of 27; a lower score generally indicates no or a lesser amount of depression/anxiety than a higher score.
Physical Performance	measure was completed at 6 months by patients only	Assessment from the patient only through data collection from the Short Physical Performance Battery (SPPB) instrument.
Anxiety Symptoms	measure was completed at 6 months by patients only	Assessment from patient only through data collection from the Generalized Anxiety Disorder Scale (GAD-7) instrument. This 7 item instrument that assess anxiety has a minimum score of 0 and a maximum score of 21, with a lower score indicating no or lesser anxiety than a higher score.
Acute Health Care Utilization	6 months	This is an assessment of patient use of health care resources, including hospitalizations and Emergency room visits. For the patient only, data will be gathered from the patient and medical record relating to the participant's emergency room visits and hospital admissions/inpatient stays during the course of their enrollment in the study.