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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,260
- 试验地点
- 2
- 主要终点
- 30-day emergency revisit or hospital admission for acute heart failure or cardiovascular mortality rate after discharge
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Multilevel Guided Discharge Planning
干预措施: Multilevel Guided Discharge Planning (Other)
Standard of care
干预措施: Standard of care (Other)
结局指标
主要结局
30-day emergency revisit or hospital admission for acute heart failure or cardiovascular mortality rate after discharge
时间窗: 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
次要结局
- Acute heart failure hospitalisation rate(at 30 days post-discharge)
- All-cause mortality rate(at 30 days post-discharge)
- Functional impairment (assessed by self-reported Barthel index)(Change from baseline to 30 days post-discharge)
- Cardiovascular mortality rate(at 30 days post-discharge)
- Satisfaction of patient or caregiver about transition of care (assessed by Care Transitions Measure questionnaire)(Within 30 days after discharge)
- Quality of live of patients (assessed by EuroQol-5D)(Within 30 days after discharge)
- All-cause emergency revisit rate(at 30 days post-discharge)
- Cardiovascular hospitalisation rate(at 30 days post-discharge)
- Free-hospitalization survival(at 30 days post-discharge)
- Acute heart failure emergency revisit rate(at 30 days post-discharge)
- Cardiovascular emergency revisit rate(at 30 days post-discharge)
- All-cause hospitalisation rate(at 30 days post-discharge)
- Pharmacological adherence (assessed by Morisky Medication Adherence Scale)(Within 30 days after discharge)
研究者
F. Javier Martin Sanchez
Principal Investigator
Hospital San Carlos, Madrid