Cirrhosis Medical Home
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Number of Participants With Complete Data
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
One member of the study team will randomize the participants and all other study personnel will remain blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Complete Data
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score)(measure was completed at 6 month enrollment by patients only)
- Cognitive Assessment With 3D CAM (Confusion Assessment Method)(measure was completed at 6 months by patients only)
- 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)
- Anxiety Symptoms(measure was completed at 6 months by patients only)
- Health Related Quality of Life: Medical Outcome Study Short Form (SF-36)(measure was completed at 6 months by patients only)
- Depression Symptoms(measure was completed at 6 months by patients only)
- Physical Performance(measure was completed at 6 months by patients only)
- Acute Health Care Utilization(6 months)
研究者
Eric Orman
Assistant Professor of Medicine
Indiana University