NCT04581369

Cirrhosis Medical Home

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cirrhosis, Liver

Interventions

Type	Name	Description
OTHER	Care Coordinator Intervention for Direct Intervention Group	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.
OTHER	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.
OTHER	Caregiver Intervention	Caregivers of the participants will be assessed for caregiver burden at 3 time points.

Timeline

• Start date: 2020-09-17
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2020-10-09
• Last updated: 2024-07-17
• Results posted: 2024-07-17

Locations

1 site across 1 country: United States