A Randomized Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 8
- 主要终点
- Quality of life for patients hospitalized with complications of advanced liver disease via Promis 29+2 survey
研究概览
简要总结
Patients with complications of advanced liver disease often have difficulties after hospital discharge that result in early hospital readmission. Poor outcomes for these patients during this transitional time could be improved through the use of innovative transitional care models. This proposal aims to examine the effect of a transitional care model, The Transitional Liver Clinic (TLC), in reducing hospital re-admissions, improving quality of life, and improving patient experience.
详细描述
This study is a stepped-wedge randomized trial of 1,000 patients with advanced liver disease at four high-volume centers over 45 months (250 participants/site; <6 participants/site/month) to evaluate the efficacy of the Transitional Liver Clinic (TLC) compared to control.
In the stepped-wedge design, all sites provide usual care (control) during the initial 9-month enrollment interval. At each subsequent 9-month interval, one site is randomized via a computer-generated randomization scheme to crossover to implement the TLC, which will continue through the final interval where all sites will have implemented the TLC.
All sites enroll for the entire 45 months and thus contribute patients to both the control and TLC groups. There are an equal number of TLC and control intervals; thus approximately 500 patients will be in each group. Participant follow-up will occur by telephone at 30 and 90 days after discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking; all sites will start out as control groups and all will eventually cross over to the TLC model. All sites will know into which group their and all other sites are enrolling.
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
- •Male or female age ≥18
- •Diagnosis of advanced liver disease, defined as either (must meet either a or b)
- •cirrhosis based on (either i or ii):
- •characteristic clinical, laboratory, and imaging findings
- •acute alcoholic hepatitis, defined by NIAAA Alcoholic Hepatitis Consortia, as
- •onset of jaundice (serum bilirubin >3.0 mg/dL) in prior 8 weeks
- •consumption of >40 (female) or 60 (male) g alcohol/day for ≥6 months, with <60 days abstinence before jaundice onset,
- •AST>50 IU/L, AST/ALT>1.5, and both values <400 IU/L
- •liver biopsy confirmation in patients with confounding factors
- •Has at least one of the following complications due to advanced liver disease occurring during hospitalization:
- •ascites requiring diuretics or paracentesis
- •hepatic encephalopathy requiring lactulose or rifaximin
- •gastrointestinal bleeding due to portal hypertension
- •Has planned discharge alive to home or a facility within 72 hours of informed consent
- •Able and willing to provide informed consent
排除标准
- •discharge under hospice
- •listed for liver transplant with MELD-Na ≥ 35
- •unable or unwilling to participate in post-discharge follow-up either in-person or virtually
- •unable to speak or understand English and/or Spanish
- •low hearing or communicative ability (examiner rated) that would interfere with interventions and outcome assessments
- •lack of access to a telephone
- •incarcerated
- •concurrent enrollment in an interventional research study
结局指标
主要结局
Quality of life for patients hospitalized with complications of advanced liver disease via Promis 29+2 survey
时间窗: 90 days after discharge of initial hospitalization at which the participant was enrolled in the study
This measure includes 4 items in each of 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference) as well as a single item assessing pain intensity. Each domain is scored using a T-score metric in which 50 corresponds to the average for the US population with a standard deviation of 10, and a higher T-score represents more of the concept being measured. For example, higher fatigue scores indicate more fatigue (worse quality of life), while higher physical function scores represent better physical function (better quality of life).
30-day hospital readmissions for patients hospitalized with complications of advanced liver disease
时间窗: 30 days after discharge of initial hospitalization at which the participant was enrolled in the study.
The primary outcome, 30-day hospital readmission, is publicly reported by CMS, and is the benchmark measure in the Hospital Readmissions Reduction Program. It is therefore the most appropriate primary outcome.
Patient satisfaction for patients hospitalized with complications of advanced liver disease via the PSQ 18 questionnaire
时间窗: 90 days after discharge of initial hospitalization at which the participant was enrolled in the study
The PSQ-18 consists of 18 items examining 7 dimensions of satisfaction with medical care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. Each item is scored with a 1 to 5 Likert scale and the individual item scores are averaged, with higher scores reflecting higher satisfaction.
次要结局
- Hospital readmissions(30 days after discharge of initial hospitalization at which the participant was enrolled in the study and 90 days after discharge of initial hospitalization at which the participant was enrolled in the study)
- Number of ER visits(30 days after discharge of initial hospitalization at which the participant was enrolled in the study and 90 days after discharge of initial hospitalization at which the participant was enrolled in the study)
- 90 day mortality(90 days after discharge of initial hospitalization at which the participant was enrolled in the study.)
- Days alive out of the hospital(90 days after discharge of initial hospitalization at which the participant was enrolled in the study.)
研究者
Eric Orman
Associate Professor of Medicine
Indiana University School of Medicine