CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Care Coordinator Intervention for Direct Intervention Group +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04581369
NCT04581369N/ACompleted

Cirrhosis Medical Home

Indiana University·interventional·Posted Oct 9, 2020·Updated Jul 17, 2024

In Brief

A clinical study evaluating Care Coordinator Intervention for Direct Intervention Group, Care Coordinator Intervention for Standard of Care Group, and 1 other intervention for Cirrhosis, Liver. Completed, enrolled 44 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 9, 2020
Enrollment StartSep 17, 2020
Primary CompletionMay 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.7 years ago

Interventions

Care Coordinator Intervention for Direct Intervention Groupother

The First Visit: The care coordinator will conduct a visit within 72 hours of hospital discharge to assess the patient's physical, cognitive, and psychological status, and will complete a needs assessment for both the patient and family caregiver. These measures will be used to guide the use of care protocols and development of the individualized care plan. The care plan will be developed with an emphasis on coordinating services with the patient's providers. The Second Visit: During the second visit, the coordinator will review the individualized care plan with both the patient and the family caregiver and will make revisions to the plan based on assessment outcomes. The 6-month Interaction Period: Approximately every 2 weeks, the coordinator will meet with the participant to revisit the care plan and to facilitate care. At the end of 6 months, all patients will be transitioned to receive full care by their primary care and specialty physicians.

Care Coordinator Intervention for Standard of Care Groupother

For participants randomized to this arm, a consultation with the care team will be arranged prior to hospital discharge. Outcome measures will be obtained by blinded research staff from all enrolled subjects at baseline, 3 months, and 6 months. This is the extent of interventions received for participants in this arm.

Caregiver Interventionother

Caregivers of the participants will be assessed for caregiver burden at 3 time points.