Discharge Planning in Emergency Department for Frail Older With AHF
追踪信息 | |||
---|---|---|---|
首次提交日期 ICMJE | September 28, 2018 | ||
首次发布日期e ICMJE | October 5, 2018 | ||
最后更新发布日期 | October 5, 2018 | ||
预计研究开始日期 ICMJE | January 15, 2019 | ||
预计主要完成日期 | December 15, 2021 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
30-day emergency revisit or hospital admission for acute heart failure or cardiovascular mortality rate after discharge[ Time Frame: at 30 days post-discharge ] The proportion of patients who have emergency revisit or hospital admission for acute heart failure or cardiovascular mortality within 30 days after discharge |
||
原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
|
||
描述性信息 | |||
简略标题 ICMJE | Discharge Planning in Emergency Department for Frail Older With AHF | ||
正式标题 ICMJE | Discharge Planning in Emergency Department to Reduce 30-day Adverse Outcomes for Frail Older Patients With Acute Heart Failure: Design and Rationale of DEED FRAIL-AHF Clinical Trial Study | ||
简要概况 | Objectives: To demonstrate the efficacy of care transition holistic intervention (Multilevel Guided Discharge Planning, MGDP) in reducing 30-day adverse outcomes among frail older patients with acute heart failure (AHF) discharged from Emergency Departments (EDs) and to validate the results of MGDP in real life. Method: Investigators will select frail patients ≥70 years with primary diagnosis of AHF discharged from EDs. The intervention will consist of MGDP implementation: 1) checklist that includes clinical recommendations and resources activations; 2) scheduling of early visit with the specialist; 3) communication with primary care; 4) providing a written instruction sheet to patient or caregiver. Phase 1: matched-pair cluster randomized clinical trial. EDs were randomly allocated to intervention (n = 10) or control (n = 10) group. Investigators will compare the outcomes between intervention and control groups. Phase 2: a quasi-experimental study. The 20 EDs will carry out the intervention. Investigators will compare the outcomes between phase 1 and phase 2 of intervention group and between phase 1 and phase 2 of control group. The main outcome is a 30-day composite endpoint (ED revisit or hospital admission for AHF and cardiovascular death) after being discharged. |
||
详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: Phase 1: Matched-pair cluster randomized clinical trial. Phase 2: a quasi-experimental study. 盲法: Interventional 盲法描述: 主要目的: Treatment |
||
适用条件 ICMJE | |||
干预项目 ICMJE |
|
||
研究工具 |
|
||
招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
1260 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | May 15, 2022 | ||
预计主要完成日期 | December 15, 2021 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Age ≥70 years. - Diagnosis of descompensated chronic heart failure. - Screening for frailty positive (ISAR ≥ 2). - Planned discharge home from Emergency Department (included observation and short stay unit). - Written informed consent provided by the patient or proxy. Exclusion Criteria: - De novo (new onset) acute heart failure (AHF). - Severe episode of acute heart failure (≥9th decile of MEESSI-AHF Score). - Uncorrected clinically significant primary valvular disease. - Acute coronary syndrome currently or within 30 days prior to enrolment. - Surgery or implanted device within 30 days prior to enrolment. - Significant arrhythmias. - Uncorrected systolic blood pressure < 100 mmHg, O2 saturation baseline < 92%, heart rate < 60 or >110 bpm, serum sodium < 130 mmol/l, serum potassium >5,5 mmol/l or hemoglobin <9 g/dL prior to enrolment. - Planned treatment with vasoactive therapies, ventricular assist device, heart surgery or transplant within 6 months. - End stage renal disease. - Severe disability. - Difficulty intervention due to significant dementia, active delirium or psychiatric disorder. - Condition with a life expectancy <1 year. - Length of stay in Emergency Department ≥96 hours. - Discharged to facility care. - Inability of outpatient follow-up. | ||
性别 |
|
||
年龄 | 最小年龄:70 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | |||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
||
IPD 共享声明 |
|
||
责任方 | F. Javier Martin Sanchez,Hospital San Carlos, Madrid | ||
研究赞助商 ICMJE | F. Javier Martin Sanchez | ||
合作者 ICMJE | |||
研究员 ICMJE |
|
||
PRS 账户 | Hospital San Carlos, Madrid | ||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |