Transition cAre inteRvention tarGeted to High-risk patiEnts To Reduce rEADmission (TARGET-READ)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,393
- 试验地点
- 8
- 主要终点
- 30-day unplanned readmission or death
研究概览
简要总结
Hospital rehospitalizations within 30 days are frequent and represent a burden for the patients, but also for the entire health care system. This study evaluates the impact of an intervention targeted to high-risk medical patients in order to reduce their risk of rehospitalization. Half of the patients will receive a set of interventions before and after their hospital discharge, while the other half will receive usual care.
详细描述
Background: Hospital readmissions within 30 days are frequent, with rates varying usually between 12 and 20%. Is it therefore recognized as important to improve the quality of the transition of care period in order to avoid as much as possible hospital readmissions. There are however still several gaps in current knowledges. First, most trials to reduce hospital readmission have been performed on specific patient populations such as patients with diabetes or heart failure, and therefore the findings may not be well generalizable to other high-risk population. Second, while some specific interventions have been showed to reduce readmission, these were complex and resources demanding, and no trial targeted these interventions to the patients who are most likely to benefit for better effectiveness, using a widely validated prediction tool, such as the "HOSPITAL" score. Finally, most studies tested unimodal interventions instead of more promising multimodal interventions.
Specific aim: the goal of this proposal is to evaluate the effect of a multimodal transitional care intervention prioritized to higher-risk medical patients on the composite of 30-day unplanned readmissions and death.
Methods: the investigators will conduct a multicenter randomized controlled trial in medical inpatients discharged home or nursing home, who are identified as having a higher risk for 30-day readmission. Risk of readmission will be predicted using the simplified HOSPITAL score, which includes 6 variables routinely available before hospital discharge and which has been previously validated in more than 200,000 patients across 6 countries in its original version, and in nearly 120,000 patients in its simplified version. Patients will be randomly assigned to the intervention group or usual care group. The primary outcome will be the first 30-day unplanned readmission or all-cause mortality. The primary analysis will be a comparison between two groups according to the intention-to-treat principle.
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
- Single (Outcomes Assessor)
盲法说明
Given the nature of the intervention, it will be not possible to blind patients and nurses providing the TARGET intervention. However, treatment allocation in the database will be coded and the study nurses collecting the outcomes or working on data cleaning and the statistician performing the analysis will be blinded to the group allocation.
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
- •Adult Patients planned to be discharged home/nursing home from a medical department.
- •Hospital stay of at least 24 hours.
- •Patient at higher risk of 30-day readmission based on the simplified HOSPITAL score.
排除标准
- •Previous enrolment in this trial.
- •Patient is not living in the country in the next 30 days.
- •No phone to be reached at.
- •Not speaking the local language.
- •Refusal to participate, or unable to give consent.
结局指标
主要结局
30-day unplanned readmission or death
时间窗: 30 days after hospital discharge
Number of patients who have a first unplanned readmission or die within 30 days after discharge (Composite endpoint).
次要结局
- Post-discharge health care utilization 3(30 days after hospital discharge)
- 30-day mortality(30 days after hospital discharge)
- Post-discharge health care utilization 4(30 days after hospital discharge)
- Time to first unplanned readmission or death(Within 30 days after hospital discharge)
- Post-discharge health care utilization 1(30 days after hospital discharge)
- First 30-day unplanned readmission(30 days after hospital discharge)
- Patient's perspective (satisfaction) on quality of transition of care between hospital and home(30 days after hospital discharge)
- Post-discharge health care utilization 2(30 days after hospital discharge)
- Costs of readmission(30 days after hospital discharge)
- Main cause of readmission or death(30 days after hospital discharge)
