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The Cirrhosis Medical Home: A Feasibility Study

肝硬化医疗之家：可行性研究

基本信息

批准号：
10202587
负责人：
Eric Orman
金额：
$ 12.15万
依托单位：
INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-07-01 至 2023-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10202587
关键词：
Acute Address American Ascites Behavioral Caring Chronic Disease Cirrhosis Clinical Cognitive Communities Complex Computer software Custom Data Data Collection Dementia Development Dropout Enrollment Ensure Feasibility Studies Feedback Frail Elderly Future Gastrointestinal Hemorrhage Goals Healthcare Systems Hepatic Encephalopathy Home Hospitalization Hospitals Impairment Indiana Individual Infection Inpatients Institute of Medicine (U.S.)Intervention Lead Length of Stay Liver Cirrhosis Measures Medical Mental Depression Modeling Morbidity - disease rate Nature Outcome Outcome Assessment Patient Care Patient-Centered Care Patients Physical Function Population Preparation Process Protocols documentation Quality of life Randomized Clinical Trials Randomized Controlled Trials Research Personnel Resources Social Functioning Societies Symptoms Testing United States Centers for Medicare and Medicaid Services Universities Vulnerable Populations biopsychosocial care coordination chronic liver disease collaborative care cost disability disabling symptom efficacy evaluation efficacy trial experience health care service health care service utilization hospital readmission improved innovation medical schools mortality novel patient oriented patient population personalized care personalized intervention psychologic randomized trial rehabilitation service screening success tool treatment as usual trial comparing

项目摘要

PROJECT SUMMARY Liver cirrhosis places a significant burden on individuals and society, causing diminished quality of life, increased disability, morbidity, and mortality; and high costs and utilization of health care resources. These outcomes could be improved with existing resources, but the current fragmented nature of the health care system does not allow for the necessary coordination to best care for this population. To address the general lack of care coordination in the health care system, collaborative care models have been developed for a wide range of clinical settings, and have successfully improved care for patients with numerous chronic diseases. Researchers at the Indiana University School of Medicine have over 20 years of experience in developing, testing, and implementing collaborative care for patients with dementia, depression, and other conditions. Building on these successes, investigators have customized the collaborative care model to best meet the unique needs of patients with decompensated cirrhosis: The Cirrhosis Medical Home (CMH). This proposal aims to establish the feasibility of performing a randomized controlled trial comparing the CMH to usual care for patients discharged from the hospital with decompensated cirrhosis. The specific aims are: (1) to test the screening and enrollment processes for a randomized trial of the CMH compared to usual care for patients discharged from the hospital with decompensated cirrhosis; (2) to assess the data collection process, outcome assessment, and the acceptability of the CMH randomized trial; and (3) to estimate the effect size of the CMH intervention on quality of life after six months. Upon completion of the proposed study, the investigators will have demonstrated the feasibility of enrolling and retaining subjects in a randomized trial of the CMH, and they will have established an estimated effect size that will ensure adequate power for a future randomized trial that will evaluate the efficacy of the CMH.

项目摘要肝硬化给个人和社会带来巨大负担，导致生活质量下降，残疾、发病率和死亡率增加;医疗保健资源的高成本和高利用率。这些利用现有资源可以改善结果，但目前医疗保健的分散性系统不允许进行必要的协调，以最好地照顾这一人口。上发言由于卫生保健系统缺乏护理协调，协作护理模式已广泛发展，该公司在一系列临床环境中发挥了重要作用，并成功地改善了对患有多种慢性疾病的患者的护理。印第安纳州大学医学院的研究人员在开发，测试，并为患有痴呆症，抑郁症和其他疾病的患者实施合作护理。在这些成功的基础上，研究人员定制了协作护理模式，以最好地满足失代偿期肝硬化患者的独特需求：肝硬化医疗之家（CMH）。这项建议目的是建立一个比较CMH和常规护理的随机对照试验的可行性失代偿期肝硬化患者出院的治疗方案。具体目的是：（1）检验 CMH与患者常规护理相比的随机试验的筛选和入组过程失代偿期肝硬化出院;（2）评估数据收集过程、结局 CMH随机试验的可接受性;（3）估计CMH的效应量 6个月后进行生活质量干预。完成拟定研究后，研究者将已经证明了在CMH的随机试验中招募和保留受试者的可行性，将确定估计的效应量，以确保未来随机试验具有足够的把握度，将评估CMH的疗效。